Alzheimer's Disease
Conditions
Keywords
Alzheimer's disease, antibody, amyloid
Brief summary
Purpose of the study is to determine whether multiple dose administration of PF-04360365 is safe and well tolerated in patient with mild to moderate Alzheimer's disease.
Interventions
BIOLOGICALPF-04360365 0.1 mg/kg
0.1 mg/kg every 60 days (10 doses total)
BIOLOGICALPF-04360365 0.5 mg/kg
0.5 mg/kg every 60 days (10 doses total)
BIOLOGICALPF-04360365 1 mg/kg
1 mg/kg every 60 days (10 doses total)
DRUGPlacebo
Placebo every 60 days (10 doses total)
BIOLOGICALPF-04360365 3 mg/kg
3 mg/kg every 60 days (10 doses total)
BIOLOGICALPF-04360365 8.5 mg/kg
8.5 mg/kg every 60 days (10 doses total)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females of non childbearing potential, age \> or = 50 * Diagnosis of probable Alzheimer's disease, consistent with criterial from both: * National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) * Diagnostic and Statistical Manual of Mental Disorders (DSM IV) * Mini-mental status exam score of 16-26 inclusive * Rosen-Modified Hachinski Ischemia Score of \< or = 4
Exclusion criteria
* Diagnosis or history of other demential or neurodegenerative disorders * Diagnosis or history of clinically significant cerebrovascular disease * Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities * History of autoimmune disorders * History of allergic or anaphylactic reactions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Plasma Concentration of PF-04360365 on Day 720 | Day 720 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300 | 0 Hour (pre-dose) on Day 300 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300 | 2 Hours on Day 300 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360 | 0 Hour (pre-dose) on Day 360 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360 | 2 Hours on Day 360 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 on Day 390 | Day 390 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420 | 0 Hour (pre-dose) on Day 420 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420 | 2 Hours on Day 420 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480 | 0 Hour (pre-dose) on Day 480 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480 | 2 Hours on Day 480 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540 | 0 Hour (pre-dose) on Day 540 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540 | 2 Hours on Day 540 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | Day 570 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 on Day 660 | Day 660 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Day 1 up to 6 months after last dose of study medication, assessed up to Month 24 | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1 | 2 Hours on Day 1 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60 | 0 Hour (pre-dose) on Day 60 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Baseline up to Month 24 | Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion. |
| Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | Baseline up to Month 24 | Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion. |
| Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 | 0 Hour on Day 0 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 | 0 Hour (pre-dose) on Day 1 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60 | 2 Hours on Day 60 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | Day 90 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120 | 0 Hour (pre-dose) on Day 120 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120 | 2 Hours on Day 120 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 on Day 150 | Day 150 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180 | 0 Hour (pre-dose) on Day 180 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180 | 2 Hours on Day 180 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 on Day 210 | Day 210 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240 | 0 Hour (pre-dose) on Day 240 | Only participants received PF-04360365 were analyzed for this outcome measure. |
| Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240 | 2 Hours on Day 240 | Only participants received PF-04360365 were analyzed for this outcome measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline | Baseline | ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion. |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19 | Baseline and Month 19 | ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion. |
| Disability Assessment for Dementia (DAD) Score at Baseline | Baseline | DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion. |
| Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19 | Baseline and Month 19 | DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion. |
| Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720 | — |
| Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720 | — |
| Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720 | Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL). |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 0 (Hour 0), 90, 570 | — |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 0 (Hour 0), 90, 570 | — |
| Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0 (Hour 0), 90, 570 | — |
| Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | Baseline up to Month 24 | Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion |
| Number of Participants With Serum Anti-Drug Anti Body (ADA) | Day 1 up to Month 24 | Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure. |
| Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 0 (Hour 0), 90, 570 | — |
Countries
Australia, Belgium, Canada, South Korea, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-04360365 0.1 mg/kg (Part A) PF-04360365 0.1 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study. | 25 |
| PF-04360365 0.5 mg/kg (Part A) PF-04360365 0.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study. | 25 |
| PF-04360365 1.0 mg/kg (Part A) PF-04360365 1.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study. | 25 |
| Placebo (Part A) Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part A of the study. | 24 |
| PF-04360365 3.0 mg/kg (Part B) PF-04360365 3.0 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study. | 32 |
| PF-04360365 8.5 mg/kg (Part B) PF-04360365 8.5 mg/kg intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study. | 31 |
| Placebo (Part B) Placebo intravenous infusion over 2 hours every 60 days up to 18 months in Part B of the study. | 32 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 | 1 | 2 | 1 | 0 |
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Other | 0 | 0 | 1 | 1 | 3 | 2 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Randomized, but not treated | 1 | 1 | 0 | 2 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 4 | 4 | 4 | 7 | 3 |
Baseline characteristics
| Characteristic | PF-04360365 0.1 mg/kg (Part A) | PF-04360365 0.5 mg/kg (Part A) | PF-04360365 1.0 mg/kg (Part A) | Placebo (Part A) | PF-04360365 3.0 mg/kg (Part B) | PF-04360365 8.5 mg/kg (Part B) | Placebo (Part B) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 8.2 | 71.9 years STANDARD_DEVIATION 9.4 | 72.2 years STANDARD_DEVIATION 8.4 | 70.0 years STANDARD_DEVIATION 7.8 | 70.5 years STANDARD_DEVIATION 8.9 | 71.8 years STANDARD_DEVIATION 7.3 | 70.4 years STANDARD_DEVIATION 10.3 | 71.1 years STANDARD_DEVIATION 8.6 |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 11 Participants | 13 Participants | 20 Participants | 17 Participants | 17 Participants | 105 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 14 Participants | 11 Participants | 12 Participants | 14 Participants | 15 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 24 / 25 | 24 / 25 | 23 / 25 | 24 / 24 | 26 / 32 | 28 / 31 | 32 / 32 |
| serious Total, serious adverse events | 7 / 25 | 8 / 25 | 7 / 25 | 3 / 24 | 7 / 32 | 10 / 31 | 3 / 32 |
Outcome results
Primary
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour on Day 0
Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
Primary
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: Day 570
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified category for rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | CSF | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | Plasma | 360.05 Nanogram per milliliter | Standard Deviation 165.65 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | CSF | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | Plasma | 2023.95 Nanogram per milliliter | Standard Deviation 911 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | CSF | 6.30 Nanogram per milliliter | Standard Deviation 10.91 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | Plasma | 4374.00 Nanogram per milliliter | Standard Deviation 1465.99 |
| Placebo (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | Plasma | 19638.68 Nanogram per milliliter | Standard Deviation 8134.26 |
| Placebo (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | CSF | 56.77 Nanogram per milliliter | Standard Deviation 23.14 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | CSF | 115.36 Nanogram per milliliter | Standard Deviation 79.21 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 570 | Plasma | 44945.95 Nanogram per milliliter | Standard Deviation 25370.94 |
Primary
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: Day 90
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified rows.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | Plasma | 286.20 Nanogram per milliliter | Standard Deviation 133.25 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | CSF | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | Plasma | 2074.48 Nanogram per milliliter | Standard Deviation 558.85 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | CSF | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | Plasma | 4277.88 Nanogram per milliliter | Standard Deviation 1073.25 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | CSF | 6.36 Nanogram per milliliter | Standard Deviation 14.22 |
| Placebo (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | CSF | 43.44 Nanogram per milliliter | Standard Deviation 17.76 |
| Placebo (Part A) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | Plasma | 16733.03 Nanogram per milliliter | Standard Deviation 5624.57 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | Plasma | 49141.68 Nanogram per milliliter | Standard Deviation 11941.83 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 90 | CSF | 157.40 Nanogram per milliliter | Standard Deviation 85.17 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 1
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 | 14.25 Nanogram per milliliter | Standard Deviation 69.81 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1 | 38.10 Nanogram per milliliter | Standard Deviation 208.68 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 120
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120 | 106.08 Nanogram per milliliter | Standard Deviation 116 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120 | 1259.68 Nanogram per milliliter | Standard Deviation 360.11 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120 | 2573.64 Nanogram per milliliter | Standard Deviation 622.86 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120 | 8781.20 Nanogram per milliliter | Standard Deviation 3267.52 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120 | 31916.04 Nanogram per milliliter | Standard Deviation 24631.87 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 180
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180 | 114.71 Nanogram per milliliter | Standard Deviation 137.86 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180 | 1344.00 Nanogram per milliliter | Standard Deviation 556.59 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180 | 2819.68 Nanogram per milliliter | Standard Deviation 819.68 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180 | 9885.71 Nanogram per milliliter | Standard Deviation 3673.92 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 180 | 30306.81 Nanogram per milliliter | Standard Deviation 11823.33 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 240
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240 | 170.64 Nanogram per milliliter | Standard Deviation 389 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240 | 1423.83 Nanogram per milliliter | Standard Deviation 582.13 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240 | 2782.17 Nanogram per milliliter | Standard Deviation 1147.38 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240 | 11221.22 Nanogram per milliliter | Standard Deviation 4030.07 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240 | 31093.81 Nanogram per milliliter | Standard Deviation 11083.26 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 300
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300 | 176.25 Nanogram per milliliter | Standard Deviation 140.95 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300 | 1690.41 Nanogram per milliliter | Standard Deviation 1585.87 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300 | 2958.13 Nanogram per milliliter | Standard Deviation 1150.02 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300 | 11935.88 Nanogram per milliliter | Standard Deviation 3779.5 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300 | 31766.30 Nanogram per milliliter | Standard Deviation 12335.11 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 360
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360 | 247.52 Nanogram per milliliter | Standard Deviation 102.75 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360 | 1377.95 Nanogram per milliliter | Standard Deviation 476.42 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360 | 3161.00 Nanogram per milliliter | Standard Deviation 972.99 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360 | 10643.58 Nanogram per milliliter | Standard Deviation 3986.99 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 360 | 31485.52 Nanogram per milliliter | Standard Deviation 12609.26 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 420
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420 | 204.62 Nanogram per milliliter | Standard Deviation 123.72 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420 | 1433.52 Nanogram per milliliter | Standard Deviation 550.12 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420 | 3102.24 Nanogram per milliliter | Standard Deviation 1146 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420 | 9711.42 Nanogram per milliliter | Standard Deviation 3012.62 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 420 | 30782.57 Nanogram per milliliter | Standard Deviation 11295.55 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 480
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480 | 162.52 Nanogram per milliliter | Standard Deviation 161.33 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480 | 1480.95 Nanogram per milliliter | Standard Deviation 557.75 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480 | 3125.25 Nanogram per milliliter | Standard Deviation 1074.07 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480 | 10585.67 Nanogram per milliliter | Standard Deviation 3272.66 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 480 | 26612.45 Nanogram per milliliter | Standard Deviation 12061.46 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 540
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540 | 177.30 Nanogram per milliliter | Standard Deviation 163.34 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540 | 1297.26 Nanogram per milliliter | Standard Deviation 578.84 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540 | 2718.38 Nanogram per milliliter | Standard Deviation 949.54 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540 | 10372.65 Nanogram per milliliter | Standard Deviation 4310.28 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540 | 32303.09 Nanogram per milliliter | Standard Deviation 35225.88 |
Primary
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 0 Hour (pre-dose) on Day 60
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60 | 33.96 Nanogram per milliliter | Standard Deviation 82.22 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60 | 792.80 Nanogram per milliliter | Standard Deviation 217.31 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60 | 1747.04 Nanogram per milliliter | Standard Deviation 311.05 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60 | 6715.34 Nanogram per milliliter | Standard Deviation 3797.08 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 60 | 30517.76 Nanogram per milliliter | Standard Deviation 34018.99 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 1
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1 | 1731.36 Nanogram per milliliter | Standard Deviation 605.07 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1 | 10051.85 Nanogram per milliliter | Standard Deviation 1857.36 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1 | 21972.09 Nanogram per milliliter | Standard Deviation 6582.5 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1 | 65832.36 Nanogram per milliliter | Standard Deviation 23334.31 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 1 | 187953.19 Nanogram per milliliter | Standard Deviation 36763.8 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 120
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120 | 2083.14 Nanogram per milliliter | Standard Deviation 549.16 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120 | 12229.60 Nanogram per milliliter | Standard Deviation 2813.13 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120 | 25263.43 Nanogram per milliliter | Standard Deviation 6395.62 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120 | 69437.52 Nanogram per milliliter | Standard Deviation 19262.08 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 120 | 191019.54 Nanogram per milliliter | Standard Deviation 65338.19 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 180
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180 | 1959.05 Nanogram per milliliter | Standard Deviation 650.77 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180 | 12096.22 Nanogram per milliliter | Standard Deviation 3346.68 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180 | 24574.57 Nanogram per milliliter | Standard Deviation 5989.22 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180 | 72597.58 Nanogram per milliliter | Standard Deviation 13930.48 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 180 | 194768.61 Nanogram per milliliter | Standard Deviation 42953.08 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 240
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240 | 1660.76 Nanogram per milliliter | Standard Deviation 511.32 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240 | 10501.00 Nanogram per milliliter | Standard Deviation 2550.48 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240 | 22340.46 Nanogram per milliliter | Standard Deviation 5364.94 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240 | 80142.40 Nanogram per milliliter | Standard Deviation 15093.45 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 240 | 216585.87 Nanogram per milliliter | Standard Deviation 32947.73 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 300
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300 | 1919.42 Nanogram per milliliter | Standard Deviation 446.62 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300 | 10774.35 Nanogram per milliliter | Standard Deviation 1736.85 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300 | 22273.26 Nanogram per milliliter | Standard Deviation 6285.72 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300 | 76511.29 Nanogram per milliliter | Standard Deviation 13832.35 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 300 | 207292.95 Nanogram per milliliter | Standard Deviation 50582.35 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 360
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360 | 2019.23 Nanogram per milliliter | Standard Deviation 396.63 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360 | 11047.68 Nanogram per milliliter | Standard Deviation 2232.06 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360 | 22833.43 Nanogram per milliliter | Standard Deviation 4544.54 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360 | 71309.58 Nanogram per milliliter | Standard Deviation 12691.07 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 360 | 203124.84 Nanogram per milliliter | Standard Deviation 35756.46 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 420
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420 | 1919.50 Nanogram per milliliter | Standard Deviation 600.41 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420 | 11513.89 Nanogram per milliliter | Standard Deviation 1589.13 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420 | 23519.67 Nanogram per milliliter | Standard Deviation 4499.54 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420 | 69975.00 Nanogram per milliliter | Standard Deviation 16885.06 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 420 | 196647.81 Nanogram per milliliter | Standard Deviation 29248.03 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 480
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480 | 1936.67 Nanogram per milliliter | Standard Deviation 484.01 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480 | 11293.26 Nanogram per milliliter | Standard Deviation 2237.99 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480 | 22930.21 Nanogram per milliliter | Standard Deviation 4146.48 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480 | 67981.00 Nanogram per milliliter | Standard Deviation 10368.3 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 480 | 169955.72 Nanogram per milliliter | Standard Deviation 35843.29 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 540
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540 | 1981.20 Nanogram per milliliter | Standard Deviation 591.23 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540 | 11291.40 Nanogram per milliliter | Standard Deviation 2033.92 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540 | 20793.73 Nanogram per milliliter | Standard Deviation 4168.51 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540 | 70660.14 Nanogram per milliliter | Standard Deviation 16140.32 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 540 | 178273.50 Nanogram per milliliter | Standard Deviation 40289 |
Primary
Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: 2 Hours on Day 60
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60 | 2018.13 Nanogram per milliliter | Standard Deviation 402.12 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60 | 11372.46 Nanogram per milliliter | Standard Deviation 2730.02 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60 | 23100.33 Nanogram per milliliter | Standard Deviation 5598.52 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60 | 81464.62 Nanogram per milliliter | Standard Deviation 25466.75 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 at 2 Hours on Day 60 | 209962.13 Nanogram per milliliter | Standard Deviation 64637.17 |
Primary
Mean Plasma Concentration of PF-04360365 on Day 150
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: Day 150
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 150 | 344.17 Nanogram per milliliter | Standard Deviation 157.08 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 150 | 2512.36 Nanogram per milliliter | Standard Deviation 804.43 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 150 | 4673.32 Nanogram per milliliter | Standard Deviation 932.48 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 on Day 150 | 17636.10 Nanogram per milliliter | Standard Deviation 6440.44 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 on Day 150 | 53918.22 Nanogram per milliliter | Standard Deviation 15265.59 |
Primary
Mean Plasma Concentration of PF-04360365 on Day 210
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: Day 210
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 210 | 245.33 Nanogram per milliliter | Standard Deviation 233.16 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 210 | 2419.25 Nanogram per milliliter | Standard Deviation 1034.32 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 210 | 4935.00 Nanogram per milliliter | Standard Deviation 1349.38 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 on Day 210 | 17973.43 Nanogram per milliliter | Standard Deviation 6279.98 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 on Day 210 | 55881.07 Nanogram per milliliter | Standard Deviation 17445.49 |
Primary
Mean Plasma Concentration of PF-04360365 on Day 390
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: Day 390
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 390 | 411.00 Nanogram per milliliter | Standard Deviation 195.94 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 390 | 2344.76 Nanogram per milliliter | Standard Deviation 780.92 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 390 | 4902.36 Nanogram per milliliter | Standard Deviation 1373.05 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 on Day 390 | 18721.04 Nanogram per milliliter | Standard Deviation 6458.67 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 on Day 390 | 54956.65 Nanogram per milliliter | Standard Deviation 20091.21 |
Primary
Mean Plasma Concentration of PF-04360365 on Day 660
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: Day 660
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 660 | 10.33 Nanogram per milliliter | Standard Deviation 47.35 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 660 | 480.78 Nanogram per milliliter | Standard Deviation 303.49 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 660 | 1212.22 Nanogram per milliliter | Standard Deviation 596.19 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 on Day 660 | 4196.50 Nanogram per milliliter | Standard Deviation 2342.84 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 on Day 660 | 7576.29 Nanogram per milliliter | Standard Deviation 5013.34 |
Primary
Mean Plasma Concentration of PF-04360365 on Day 720
Only participants received PF-04360365 were analyzed for this outcome measure.
Time frame: Day 720
Population: PK analysis set included all participants who received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 720 | 0.00 Nanogram per milliliter | Standard Deviation 0 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 720 | 198.70 Nanogram per milliliter | Standard Deviation 206.3 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of PF-04360365 on Day 720 | 590.56 Nanogram per milliliter | Standard Deviation 380.08 |
| Placebo (Part A) | Mean Plasma Concentration of PF-04360365 on Day 720 | 1583.22 Nanogram per milliliter | Standard Deviation 1163.66 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of PF-04360365 on Day 720 | 2795.30 Nanogram per milliliter | Standard Deviation 1606.9 |
Primary
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities
Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral/meningeal enhancement, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyperintensities) were assessed from structural MRI. Participants with brain abnormality other than those listed above, assessed using MRI scan, were reported under other abnormality. Baseline was defined as the last assessment prior to the first study drug infusion.
Time frame: Baseline up to Month 24
Population: Safety analysis set included all participants who received an infusion of study medication (including partial infusions). Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subcortical Grey Matter Infarcts | 0 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Infarcts | 0 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral/Meningeal Enhancement | 0 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cortical Infarcts | 1 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Hyper Intensities | 0 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Micro Hemorrhage | 4 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral Edema | 0 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Other Abnormality | 12 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subdural Hematoma | 0 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subdural Hematoma | 1 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subcortical Grey Matter Infarcts | 0 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Hyper Intensities | 3 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Infarcts | 1 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Micro Hemorrhage | 7 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral Edema | 1 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cortical Infarcts | 0 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral/Meningeal Enhancement | 1 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Other Abnormality | 9 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Infarcts | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral/Meningeal Enhancement | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subdural Hematoma | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subcortical Grey Matter Infarcts | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cortical Infarcts | 2 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral Edema | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Hyper Intensities | 2 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Other Abnormality | 8 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Micro Hemorrhage | 2 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Infarcts | 0 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cortical Infarcts | 0 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral/Meningeal Enhancement | 0 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Other Abnormality | 10 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Micro Hemorrhage | 6 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral Edema | 0 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subdural Hematoma | 0 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Hyper Intensities | 2 Participants |
| Placebo (Part A) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subcortical Grey Matter Infarcts | 0 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral Edema | 0 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Micro Hemorrhage | 3 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subdural Hematoma | 0 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cortical Infarcts | 0 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subcortical Grey Matter Infarcts | 1 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Hyper Intensities | 4 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Other Abnormality | 8 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral/Meningeal Enhancement | 0 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Infarcts | 0 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cortical Infarcts | 1 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subcortical Grey Matter Infarcts | 1 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Other Abnormality | 12 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subdural Hematoma | 0 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Hyper Intensities | 0 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Micro Hemorrhage | 6 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral Edema | 0 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Infarcts | 0 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral/Meningeal Enhancement | 0 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subdural Hematoma | 0 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Other Abnormality | 10 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Hyper Intensities | 2 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cortical Infarcts | 0 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | White Matter Infarcts | 2 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral/Meningeal Enhancement | 0 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Subcortical Grey Matter Infarcts | 0 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Micro Hemorrhage | 6 Participants |
| Placebo (Part B) | Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities | Cerebral Edema | 0 Participants |
Primary
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)
Brain MRI included gadolinium contrast if investigator determined this was necessary for participant care either based on clinical signs or the non-contrast MRI. This decision was made by the investigator on the basis of change in the clinical examination or in response to a possible abnormality seen on the non-contrast brain MRI. Baseline was defined as the last assessment prior to the first study drug infusion.
Time frame: Baseline up to Month 24
Population: Safety analysis set included all participants who received an infusion of study medication (including partial infusions). Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | 3 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | 1 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | 2 Participants |
| Placebo (Part A) | Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | 1 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | 1 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | 2 Participants |
| Placebo (Part B) | Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI) | 3 Participants |
Primary
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs are events between first dose of study medication and up to 6 months after last dose that were absent before treatment or worsened relative to pre-treatment state.
Time frame: Day 1 up to 6 months after last dose of study medication, assessed up to Month 24
Population: Safety analysis set included all participants who received an infusion of study medication (including partial infusions).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 7 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 24 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 24 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 8 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 24 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 7 Participants |
| Placebo (Part A) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 3 Participants |
| Placebo (Part A) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 24 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 27 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 7 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 28 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 10 Participants |
| Placebo (Part B) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | AEs | 32 Participants |
| Placebo (Part B) | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | SAEs | 3 Participants |
Secondary
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Time frame: Baseline
Population: Full analysis set (FAS) included all randomized participants who had received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline | 20.0 Units on a scale | Standard Deviation 7.87 |
| PF-04360365 0.5 mg/kg (Part A) | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline | 20.4 Units on a scale | Standard Deviation 8.19 |
| PF-04360365 1.0 mg/kg (Part A) | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline | 20.8 Units on a scale | Standard Deviation 6.08 |
| Placebo (Part A) | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline | 20.0 Units on a scale | Standard Deviation 6.98 |
| PF-04360365 3.0 mg/kg (Part B) | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline | 19.4 Units on a scale | Standard Deviation 6.96 |
| PF-04360365 8.5 mg/kg (Part B) | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline | 24.5 Units on a scale | Standard Deviation 10.15 |
| Placebo (Part B) | Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Baseline | 18.4 Units on a scale | Standard Deviation 7.45 |
Secondary
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19
ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprised of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). ADAS-cog total score was calculated as the sum of scores for the 11 items and ranged from 0 to 70. Higher total and individual item scores indicate greater cognitive impairment. Baseline was defined as the last assessment prior to the first study drug infusion.
Time frame: Baseline and Month 19
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19 | 8.36 Units on a scale | Standard Error 2.07 |
| PF-04360365 0.5 mg/kg (Part A) | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19 | 9.00 Units on a scale | Standard Error 2.2 |
| PF-04360365 1.0 mg/kg (Part A) | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19 | 9.25 Units on a scale | Standard Error 2.2 |
| Placebo (Part A) | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19 | 6.98 Units on a scale | Standard Error 2.22 |
| PF-04360365 3.0 mg/kg (Part B) | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19 | 9.58 Units on a scale | Standard Error 1.95 |
| PF-04360365 8.5 mg/kg (Part B) | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19 | 8.71 Units on a scale | Standard Error 1.99 |
| Placebo (Part B) | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Score at Month 19 | 7.85 Units on a scale | Standard Error 1.81 |
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.650490% CI: [-3.68, 6.45]Mixed Models Analysis
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.521390% CI: [-3.2, 7.23]Mixed Models Analysis
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.469890% CI: [-2.94, 7.48]Mixed Models Analysis
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.518390% CI: [-2.71, 6.17]Mixed Models Analysis
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.752990% CI: [-3.65, 5.35]Mixed Models Analysis
Secondary
Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Time frame: Baseline and Month 19
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19 | -20.09 Units on a scale | Standard Error 3.8 |
| PF-04360365 0.5 mg/kg (Part A) | Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19 | -16.20 Units on a scale | Standard Error 3.9 |
| PF-04360365 1.0 mg/kg (Part A) | Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19 | -15.18 Units on a scale | Standard Error 3.91 |
| Placebo (Part A) | Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19 | -16.02 Units on a scale | Standard Error 4.07 |
| PF-04360365 3.0 mg/kg (Part B) | Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19 | -22.53 Units on a scale | Standard Error 4.17 |
| PF-04360365 8.5 mg/kg (Part B) | Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19 | -18.12 Units on a scale | Standard Error 4.3 |
| Placebo (Part B) | Change From Baseline in Disability Assessment for Dementia (DAD) Score at Month 19 | -18.44 Units on a scale | Standard Error 4 |
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.468890% CI: [-13.38, 5.24]Mixed Models Analysis
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.974390% CI: [-9.59, 9.22]Mixed Models Analysis
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.882490% CI: [-8.57, 10.25]Mixed Models Analysis
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.483190% CI: [-13.77, 5.58]Mixed Models Analysis
Comparison: Mixed model repeated measures used terms for treatment, visit, baseline value, country, and treatment-by-visit interaction, with unstructured covariance matrix.p-value: 0.956290% CI: [-9.48, 10.13]Mixed Models Analysis
Secondary
Disability Assessment for Dementia (DAD) Score at Baseline
DAD is a functional assessment based on interview with the caregiver. It consisted of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item was scored as yes = 1, no = 0 and not applicable= N/A. A total score was obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A were not considered for the total score. DAD total score ranged from 0 to 100, with higher scores indicating better functioning. Baseline was defined as the last assessment prior to the first study drug infusion.
Time frame: Baseline
Population: FAS included all randomized participants who had received at least 1 infusion of study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Disability Assessment for Dementia (DAD) Score at Baseline | 79.6 Units on a scale | Standard Deviation 13.73 |
| PF-04360365 0.5 mg/kg (Part A) | Disability Assessment for Dementia (DAD) Score at Baseline | 83.4 Units on a scale | Standard Deviation 12.83 |
| PF-04360365 1.0 mg/kg (Part A) | Disability Assessment for Dementia (DAD) Score at Baseline | 78.1 Units on a scale | Standard Deviation 20.55 |
| Placebo (Part A) | Disability Assessment for Dementia (DAD) Score at Baseline | 78.0 Units on a scale | Standard Deviation 16.4 |
| PF-04360365 3.0 mg/kg (Part B) | Disability Assessment for Dementia (DAD) Score at Baseline | 83.5 Units on a scale | Standard Deviation 13.16 |
| PF-04360365 8.5 mg/kg (Part B) | Disability Assessment for Dementia (DAD) Score at Baseline | 77.1 Units on a scale | Standard Deviation 20.16 |
| Placebo (Part B) | Disability Assessment for Dementia (DAD) Score at Baseline | 80.7 Units on a scale | Standard Deviation 15.6 |
Secondary
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40)
Time frame: Day 0 (Hour 0), 90, 570
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 0 | 18100.00 Picogram per milliliter | Standard Deviation 4513.31 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 16833.33 Picogram per milliliter | Standard Deviation 4244.21 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 4930.00 Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 10775.00 Picogram per milliliter | Standard Deviation 5811.55 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 0 | 11907.50 Picogram per milliliter | Standard Deviation 3569.78 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 14733.33 Picogram per milliliter | Standard Deviation 4341.27 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 0 | 11700.00 Picogram per milliliter | Standard Deviation 1525.34 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 8445.00 Picogram per milliliter | Standard Deviation 2128.39 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 12350.00 Picogram per milliliter | Standard Deviation 2537.06 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 0 | 7947.50 Picogram per milliliter | Standard Deviation 2501 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 5235.00 Picogram per milliliter | Standard Deviation 572.76 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 7977.50 Picogram per milliliter | Standard Deviation 1542.95 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 7108.89 Picogram per milliliter | Standard Deviation 1712.55 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 0 | 14672.31 Picogram per milliliter | Standard Deviation 6776.14 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 14106.36 Picogram per milliliter | Standard Deviation 5225.42 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 13733.00 Picogram per milliliter | Standard Deviation 4712.08 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 0 | 12301.82 Picogram per milliliter | Standard Deviation 4272.94 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 9315.00 Picogram per milliliter | Standard Deviation 3779.86 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 4730.00 Picogram per milliliter | Standard Deviation 1235.86 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 11745.71 Picogram per milliliter | Standard Deviation 3627.05 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 0 | 12713.53 Picogram per milliliter | Standard Deviation 5960.78 |
Secondary
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42)
Time frame: Day 0 (Hour 0), 90, 570
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 802.00 Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 1009.00 Picogram per milliliter | Standard Deviation 298.29 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 0 | 983.00 Picogram per milliliter | Standard Deviation 370.31 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 0 | 800.13 Picogram per milliliter | Standard Deviation 267.63 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 821.33 Picogram per milliliter | Standard Deviation 235.97 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 803.00 Picogram per milliliter | Standard Deviation 7.55 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 866.00 Picogram per milliliter | Standard Deviation 176.4 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 0 | 851.75 Picogram per milliliter | Standard Deviation 17.75 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 958.00 Picogram per milliliter | — |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 557.50 Picogram per milliliter | Standard Deviation 159.32 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 421.50 Picogram per milliliter | Standard Deviation 142.13 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 0 | 694.00 Picogram per milliliter | Standard Deviation 217.22 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 0 | 959.54 Picogram per milliliter | Standard Deviation 281.3 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 487.11 Picogram per milliliter | Standard Deviation 483.28 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 949.36 Picogram per milliliter | Standard Deviation 223.5 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 895.80 Picogram per milliliter | Standard Deviation 273.28 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 0 | 817.36 Picogram per milliliter | Standard Deviation 323.31 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 582.33 Picogram per milliliter | Standard Deviation 489.19 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 778.29 Picogram per milliliter | Standard Deviation 221.01 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 665.25 Picogram per milliliter | Standard Deviation 358.57 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 0 | 803.41 Picogram per milliliter | Standard Deviation 232.38 |
Secondary
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x)
Time frame: Day 0 (Hour 0), 90, 570
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 12200.00 Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 0 | 27400.00 Picogram per milliliter | Standard Deviation 8361.22 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 31766.67 Picogram per milliliter | Standard Deviation 6906.04 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 31050.00 Picogram per milliliter | Standard Deviation 9056.88 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 32466.67 Picogram per milliliter | Standard Deviation 7305.02 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 0 | 30187.50 Picogram per milliliter | Standard Deviation 10584.28 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 22775.00 Picogram per milliliter | Standard Deviation 3856.06 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 0 | 32150.00 Picogram per milliliter | Standard Deviation 10033.44 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 15250.00 Picogram per milliliter | Standard Deviation 7424.62 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 16025.00 Picogram per milliliter | Standard Deviation 3279.61 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 0 | 18425.00 Picogram per milliliter | Standard Deviation 5034.13 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 11650.00 Picogram per milliliter | Standard Deviation 1626.35 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 27850.00 Picogram per milliliter | Standard Deviation 11601.4 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 0 | 31553.85 Picogram per milliliter | Standard Deviation 10242.12 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 13378.75 Picogram per milliliter | Standard Deviation 3643.53 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 0 | 25536.36 Picogram per milliliter | Standard Deviation 9602.63 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 10688.57 Picogram per milliliter | Standard Deviation 2937.67 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 31580.00 Picogram per milliliter | Standard Deviation 16461.79 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 10467.50 Picogram per milliliter | Standard Deviation 2876.3 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 22888.57 Picogram per milliliter | Standard Deviation 9294.7 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 0 | 25923.53 Picogram per milliliter | Standard Deviation 8724.93 |
Secondary
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau)
Time frame: Day 0 (Hour 0), 90, 570
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: tau | 188.90 Picogram per milliliter | Standard Deviation 118.6 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: p-tau | 70.70 Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: p-tau | 73.27 Picogram per milliliter | Standard Deviation 7.28 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: p-tau | 72.53 Picogram per milliliter | Standard Deviation 10.46 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: tau | 78.00 Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: tau | 202.33 Picogram per milliliter | Standard Deviation 112.51 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: p-tau | 70.15 Picogram per milliliter | Standard Deviation 31.21 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: p-tau | 65.89 Picogram per milliliter | Standard Deviation 28.22 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: tau | 223.79 Picogram per milliliter | Standard Deviation 99.03 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: tau | 210.33 Picogram per milliliter | Standard Deviation 98.42 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: p-tau | 112.10 Picogram per milliliter | Standard Deviation 45.51 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: tau | 158.98 Picogram per milliliter | Standard Deviation 93.46 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: p-tau | 64.50 Picogram per milliliter | Standard Deviation 30.38 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: tau | 190.43 Picogram per milliliter | Standard Deviation 102.86 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: tau | 167.78 Picogram per milliliter | Standard Deviation 83.2 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: tau | 90.80 Picogram per milliliter | Standard Deviation 28.57 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: p-tau | 49.13 Picogram per milliliter | Standard Deviation 13.83 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: p-tau | 76.45 Picogram per milliliter | Standard Deviation 50.28 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: p-tau | 53.65 Picogram per milliliter | Standard Deviation 34.58 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: tau | 96.13 Picogram per milliliter | Standard Deviation 34.73 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: tau | 49.20 Picogram per milliliter | Standard Deviation 5.37 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: p-tau | 34.98 Picogram per milliliter | Standard Deviation 11.4 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: p-tau | 47.13 Picogram per milliliter | Standard Deviation 19.96 |
| Placebo (Part A) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: tau | 117.38 Picogram per milliliter | Standard Deviation 22.52 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: tau | 217.64 Picogram per milliliter | Standard Deviation 149.25 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: tau | 219.09 Picogram per milliliter | Standard Deviation 192.54 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: p-tau | 56.72 Picogram per milliliter | Standard Deviation 30.64 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: p-tau | 54.43 Picogram per milliliter | Standard Deviation 31.79 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: tau | 166.18 Picogram per milliliter | Standard Deviation 115.72 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: p-tau | 60.26 Picogram per milliliter | Standard Deviation 36.98 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: p-tau | 49.45 Picogram per milliliter | Standard Deviation 23.76 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: tau | 167.40 Picogram per milliliter | Standard Deviation 101.42 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: tau | 169.76 Picogram per milliliter | Standard Deviation 121.25 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: tau | 139.94 Picogram per milliliter | Standard Deviation 83.16 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: p-tau | 57.77 Picogram per milliliter | Standard Deviation 31.63 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: p-tau | 42.47 Picogram per milliliter | Standard Deviation 16.69 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: p-tau | 59.17 Picogram per milliliter | Standard Deviation 28.41 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: tau | 124.24 Picogram per milliliter | Standard Deviation 51.28 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: tau | 158.00 Picogram per milliliter | Standard Deviation 62.91 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 0: tau | 196.31 Picogram per milliliter | Standard Deviation 147.04 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 570: p-tau | 53.59 Picogram per milliliter | Standard Deviation 32.04 |
| Placebo (Part B) | Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) | Day 90: p-tau | 47.98 Picogram per milliliter | Standard Deviation 16.91 |
Secondary
Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40)
Time frame: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here 'Number Analyzed' signifies participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 540 | 4149.30 Picogram per milliliter | Standard Deviation 1711.36 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 300 | 2756.25 Picogram per milliliter | Standard Deviation 1012.41 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 360 | 3277.27 Picogram per milliliter | Standard Deviation 983.77 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 420 | 1451.33 Picogram per milliliter | Standard Deviation 602.01 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 60 | 2502.39 Picogram per milliliter | Standard Deviation 920.12 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 120 | 1345.72 Picogram per milliliter | Standard Deviation 525.64 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 300 | 1630.16 Picogram per milliliter | Standard Deviation 662.16 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 3147.27 Picogram per milliliter | Standard Deviation 1910.78 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 240 | 2868.10 Picogram per milliliter | Standard Deviation 778.74 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 420 | 2647.78 Picogram per milliliter | Standard Deviation 826.97 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 180 | 2973.05 Picogram per milliliter | Standard Deviation 1614.36 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 540 | 2437.70 Picogram per milliliter | Standard Deviation 1483.48 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 1 | 185.52 Picogram per milliliter | Standard Deviation 109.7 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 240 | 1471.84 Picogram per milliliter | Standard Deviation 549.7 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 60 | 1073.50 Picogram per milliliter | Standard Deviation 409.71 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 210 | 2274.58 Picogram per milliliter | Standard Deviation 878.71 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 480 | 1931.78 Picogram per milliliter | Standard Deviation 1339.28 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 390 | 2543.50 Picogram per milliliter | Standard Deviation 1446.05 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 660 | 1318.67 Picogram per milliliter | Standard Deviation 927.31 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 1 | 1239.41 Picogram per milliliter | Standard Deviation 388.07 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 180 | 1632.54 Picogram per milliliter | Standard Deviation 931.22 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 720 | 913.57 Picogram per milliliter | Standard Deviation 273.04 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 150 | 2564.21 Picogram per milliliter | Standard Deviation 1566.85 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 480 | 3336.29 Picogram per milliliter | Standard Deviation 1529.23 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 360 | 1694.26 Picogram per milliliter | Standard Deviation 566.45 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 120 | 3000.00 Picogram per milliliter | Standard Deviation 1145.59 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 2096.40 Picogram per milliliter | Standard Deviation 896.2 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 13888.80 Picogram per milliliter | Standard Deviation 5357.63 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 1 | 145.92 Picogram per milliliter | Standard Deviation 104.5 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 16370.00 Picogram per milliliter | Standard Deviation 10166.72 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 60 | 8676.09 Picogram per milliliter | Standard Deviation 2600.95 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 60 | 5860.00 Picogram per milliliter | Standard Deviation 1923.23 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 1 | 1580.70 Picogram per milliliter | Standard Deviation 500.06 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 180 | 11533.48 Picogram per milliliter | Standard Deviation 3718.57 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 120 | 7823.75 Picogram per milliliter | Standard Deviation 3119.88 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 540 | 12428.67 Picogram per milliliter | Standard Deviation 6799.53 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 360 | 11555.79 Picogram per milliliter | Standard Deviation 3710.85 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 720 | 3631.50 Picogram per milliliter | Standard Deviation 2062.26 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 540 | 10103.16 Picogram per milliliter | Standard Deviation 6545 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 480 | 12793.68 Picogram per milliliter | Standard Deviation 5639.73 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 360 | 8194.76 Picogram per milliliter | Standard Deviation 3665.29 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 390 | 10594.76 Picogram per milliliter | Standard Deviation 3948.17 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 300 | 10428.50 Picogram per milliliter | Standard Deviation 2989.2 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 300 | 8989.55 Picogram per milliliter | Standard Deviation 4776.13 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 420 | 7863.81 Picogram per milliliter | Standard Deviation 3449.31 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 240 | 11830.45 Picogram per milliliter | Standard Deviation 5542.51 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 420 | 10538.42 Picogram per milliliter | Standard Deviation 4177.09 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 660 | 4411.24 Picogram per milliliter | Standard Deviation 3426.58 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 240 | 8583.75 Picogram per milliliter | Standard Deviation 4003.84 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 210 | 14409.58 Picogram per milliliter | Standard Deviation 5966.02 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 480 | 10108.10 Picogram per milliliter | Standard Deviation 5878.7 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 180 | 8604.40 Picogram per milliliter | Standard Deviation 3269.47 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 150 | 16254.80 Picogram per milliliter | Standard Deviation 5774.43 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 120 | 11108.00 Picogram per milliliter | Standard Deviation 3594.09 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 720 | 6642.94 Picogram per milliliter | Standard Deviation 5669.98 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 120 | 16724.00 Picogram per milliliter | Standard Deviation 7330.78 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 180 | 17727.60 Picogram per milliliter | Standard Deviation 7878.69 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 180 | 23146.36 Picogram per milliliter | Standard Deviation 9074.15 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 360 | 16970.95 Picogram per milliliter | Standard Deviation 6137.24 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 390 | 21660.45 Picogram per milliliter | Standard Deviation 7216.95 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 420 | 14975.24 Picogram per milliliter | Standard Deviation 7980.85 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 420 | 16612.22 Picogram per milliliter | Standard Deviation 5658.05 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 480 | 16535.00 Picogram per milliliter | Standard Deviation 9242.28 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 1 | 162.04 Picogram per milliliter | Standard Deviation 125 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 1 | 1665.57 Picogram per milliliter | Standard Deviation 953.5 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 60 | 11643.20 Picogram per milliliter | Standard Deviation 4588.36 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 60 | 14517.08 Picogram per milliliter | Standard Deviation 6129.96 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 25008.00 Picogram per milliliter | Standard Deviation 8167.92 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 120 | 20834.78 Picogram per milliliter | Standard Deviation 8115.4 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 150 | 27640.00 Picogram per milliliter | Standard Deviation 11619.21 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 210 | 28548.00 Picogram per milliliter | Standard Deviation 11006.03 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 240 | 16937.08 Picogram per milliliter | Standard Deviation 7343.63 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 240 | 20021.25 Picogram per milliliter | Standard Deviation 7600.16 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 300 | 17817.08 Picogram per milliliter | Standard Deviation 13181.85 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 300 | 17809.57 Picogram per milliliter | Standard Deviation 6105.73 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 360 | 15651.74 Picogram per milliliter | Standard Deviation 5075.04 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 480 | 16610.00 Picogram per milliliter | Standard Deviation 6540.14 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 540 | 27048.75 Picogram per milliliter | Standard Deviation 23150.54 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 540 | 31972.67 Picogram per milliliter | Standard Deviation 24882.62 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 32728.24 Picogram per milliliter | Standard Deviation 20157.92 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 660 | 8720.00 Picogram per milliliter | Standard Deviation 4958.03 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 180 | 225.17 Picogram per milliliter | Standard Deviation 94.23 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 1 | 180.54 Picogram per milliliter | Standard Deviation 108.32 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 300 | 190.38 Picogram per milliliter | Standard Deviation 80.76 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 420 | 157.80 Picogram per milliliter | Standard Deviation 91.81 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 240 | 182.71 Picogram per milliliter | Standard Deviation 60.37 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 180 | 182.41 Picogram per milliliter | Standard Deviation 86.46 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 240 | 164.29 Picogram per milliliter | Standard Deviation 46.78 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 210 | 191.82 Picogram per milliliter | Standard Deviation 92.92 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 540 | 186.69 Picogram per milliliter | Standard Deviation 95.55 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 420 | 151.13 Picogram per milliliter | Standard Deviation 86.07 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 120 | 192.91 Picogram per milliliter | Standard Deviation 110.77 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 60 | 209.46 Picogram per milliliter | Standard Deviation 71.27 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 720 | 330.11 Picogram per milliliter | Standard Deviation 112.78 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 237.12 Picogram per milliliter | Standard Deviation 176.71 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 120 | 191.95 Picogram per milliliter | Standard Deviation 76.36 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 204.25 Picogram per milliliter | Standard Deviation 71.71 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 540 | 190.94 Picogram per milliliter | Standard Deviation 127 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 360 | 211.33 Picogram per milliliter | Standard Deviation 101.44 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 480 | 133.53 Picogram per milliliter | Standard Deviation 91.3 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 360 | 236.71 Picogram per milliliter | Standard Deviation 190.38 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 390 | 150.81 Picogram per milliliter | Standard Deviation 85.06 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 150 | 195.96 Picogram per milliliter | Standard Deviation 78.74 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 60 | 227.57 Picogram per milliliter | Standard Deviation 60.84 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 300 | 208.85 Picogram per milliliter | Standard Deviation 108.79 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 660 | 290.63 Picogram per milliliter | Standard Deviation 244.94 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 1 | 187.95 Picogram per milliliter | Standard Deviation 55.99 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 480 | 139.61 Picogram per milliliter | Standard Deviation 106.88 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 540 | 52720.91 Picogram per milliliter | Standard Deviation 26005.06 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 57333.33 Picogram per milliliter | Standard Deviation 15829.03 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 120 | 36926.67 Picogram per milliliter | Standard Deviation 15677.13 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 720 | 13954.48 Picogram per milliliter | Standard Deviation 9828.94 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 58548.10 Picogram per milliliter | Standard Deviation 25034.67 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 120 | 38466.67 Picogram per milliliter | Standard Deviation 12659.44 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 150 | 52753.33 Picogram per milliliter | Standard Deviation 19076.48 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 480 | 74334.78 Picogram per milliliter | Standard Deviation 21163.94 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 180 | 38644.00 Picogram per milliliter | Standard Deviation 13630.61 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 210 | 51135.71 Picogram per milliliter | Standard Deviation 14603.53 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 420 | 44047.62 Picogram per milliliter | Standard Deviation 21069.28 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 180 | 35539.29 Picogram per milliliter | Standard Deviation 12873.73 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 240 | 36451.85 Picogram per milliliter | Standard Deviation 10133.13 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 240 | 35996.00 Picogram per milliliter | Standard Deviation 9149.79 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 420 | 47820.83 Picogram per milliliter | Standard Deviation 23683.71 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 300 | 37692.31 Picogram per milliliter | Standard Deviation 15132.16 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 390 | 54165.20 Picogram per milliliter | Standard Deviation 20804.9 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 300 | 42245.83 Picogram per milliliter | Standard Deviation 12637.11 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 660 | 27949.09 Picogram per milliliter | Standard Deviation 14956.33 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 360 | 30459.62 Picogram per milliliter | Standard Deviation 13619.52 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 480 | 66049.05 Picogram per milliliter | Standard Deviation 37625.89 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 360 | 31191.67 Picogram per milliliter | Standard Deviation 10742.4 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 540 | 52960.00 Picogram per milliliter | Standard Deviation 25018.95 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 1 | 1924.50 Picogram per milliliter | Standard Deviation 773 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 60 | 33203.45 Picogram per milliliter | Standard Deviation 13116.74 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 1 | 318.09 Picogram per milliliter | Standard Deviation 495.37 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 60 | 32306.90 Picogram per milliliter | Standard Deviation 11373.09 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 77292.38 Picogram per milliliter | Standard Deviation 46608.1 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 180 | 61634.78 Picogram per milliliter | Standard Deviation 21758.96 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 300 | 55488.89 Picogram per milliliter | Standard Deviation 17874.01 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 390 | 77274.78 Picogram per milliliter | Standard Deviation 33435.47 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 1 | 192.03 Picogram per milliliter | Standard Deviation 199.53 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 150 | 75033.33 Picogram per milliliter | Standard Deviation 19112.32 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 180 | 67450.00 Picogram per milliliter | Standard Deviation 21320.3 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 300 | 54838.10 Picogram per milliliter | Standard Deviation 14484.59 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 720 | 22094.00 Picogram per milliliter | Standard Deviation 13058.87 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 480 | 77302.27 Picogram per milliliter | Standard Deviation 44463.25 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 360 | 64868.42 Picogram per milliliter | Standard Deviation 30014.29 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 660 | 42087.62 Picogram per milliliter | Standard Deviation 26245.07 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 60 | 66972.41 Picogram per milliliter | Standard Deviation 19944.83 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 480 | 102094.44 Picogram per milliliter | Standard Deviation 43738.4 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 120 | 76860.87 Picogram per milliliter | Standard Deviation 22351.34 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 60 | 69627.27 Picogram per milliliter | Standard Deviation 21824.67 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 540 | 77010.48 Picogram per milliliter | Standard Deviation 50743.64 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 360 | 48904.35 Picogram per milliliter | Standard Deviation 18386.82 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 120 | 75514.81 Picogram per milliliter | Standard Deviation 22013.7 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 540 | 84750.00 Picogram per milliliter | Standard Deviation 42228.62 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 210 | 71200.00 Picogram per milliliter | Standard Deviation 17902.92 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 95967.86 Picogram per milliliter | Standard Deviation 27202.68 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 240 | 58873.08 Picogram per milliliter | Standard Deviation 21088.17 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 420 | 65819.05 Picogram per milliliter | Standard Deviation 42467.11 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 420 | 70846.67 Picogram per milliliter | Standard Deviation 41555.5 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 1 | 1764.64 Picogram per milliliter | Standard Deviation 546.77 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 240 | 58225.00 Picogram per milliliter | Standard Deviation 20401.28 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 720 | 358.04 Picogram per milliliter | Standard Deviation 148.65 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 180 | 150.79 Picogram per milliliter | Standard Deviation 99.12 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 1 | 184.19 Picogram per milliliter | Standard Deviation 124.59 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 540 | 198.00 Picogram per milliliter | Standard Deviation 114.84 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 300 | 149.20 Picogram per milliliter | Standard Deviation 122.88 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 360 | 87.18 Picogram per milliliter | Standard Deviation 96.11 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 240 | 141.40 Picogram per milliliter | Standard Deviation 106.52 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 150 | 148.47 Picogram per milliliter | Standard Deviation 106.04 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 120 | 168.41 Picogram per milliliter | Standard Deviation 81.95 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 420 | 201.31 Picogram per milliliter | Standard Deviation 165.16 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 60 | 195.83 Picogram per milliliter | Standard Deviation 110.94 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 300 | 245.31 Picogram per milliliter | Standard Deviation 239.9 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 1 | 180.22 Picogram per milliliter | Standard Deviation 117.09 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 360 | 156.68 Picogram per milliliter | Standard Deviation 148.86 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 390 | 131.07 Picogram per milliliter | Standard Deviation 102.02 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 540 | 230.30 Picogram per milliliter | Standard Deviation 71.67 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 90 | 157.31 Picogram per milliliter | Standard Deviation 107.72 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 210 | 189.13 Picogram per milliliter | Standard Deviation 78.73 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 180 | 161.48 Picogram per milliliter | Standard Deviation 166.6 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 480 | 252.00 Picogram per milliliter | Standard Deviation 135.67 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 240 | 171.66 Picogram per milliliter | Standard Deviation 98.41 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 420 | 181.83 Picogram per milliliter | Standard Deviation 123.4 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 480 | 310.39 Picogram per milliliter | Standard Deviation 302.75 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 0 Hour Day 60 | 158.16 Picogram per milliliter | Standard Deviation 121.12 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | 2 Hours Day 120 | 177.55 Picogram per milliliter | Standard Deviation 94.5 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 660 | 321.46 Picogram per milliliter | Standard Deviation 140.99 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-40 (Aβ1-40) | Day 570 | 192.13 Picogram per milliliter | Standard Deviation 104.14 |
Secondary
Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42)
Results are not reported for PF-04360365 0.1, 0.5, 1.0 mg/kg, Placebo (Part A and B) arms because plasma Aβ1-42 concentrations were sporadic and below the lower limit of quantification (20 pg/mL).
Time frame: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 180 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 300 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 240 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 420 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 180 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 120 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 150 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 1 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 60 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 480 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 210 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 720 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 660 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 360 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 300 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 540 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 540 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 1 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 390 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 60 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 420 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 360 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 240 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 480 | NA Picogram per milliliter | — |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 120 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 60 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 120 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 180 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 150 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 60 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 540 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 480 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 120 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 480 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 180 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 420 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 210 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 240 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 1 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 300 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 420 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 360 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 390 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 540 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 360 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 660 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 720 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 300 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 1 | NA Picogram per milliliter | — |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 240 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 480 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 720 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 360 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 540 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 1 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 390 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 1 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 360 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 660 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 60 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 120 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 60 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 420 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 540 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 210 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 150 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 480 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 180 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 240 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 300 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 420 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 120 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 180 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 300 | NA Picogram per milliliter | — |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 240 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 540 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 1 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 1 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 60 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 120 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 150 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 210 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 240 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 480 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 60 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 120 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 180 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 180 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 240 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 300 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 300 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 360 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 360 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 390 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 420 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 420 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 480 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 540 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 660 | NA Picogram per milliliter | — |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 720 | NA Picogram per milliliter | — |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 480 | 7.50 Picogram per milliliter | Standard Deviation 14 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 1 | 13.43 Picogram per milliliter | Standard Deviation 25.72 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 390 | 12.57 Picogram per milliliter | Standard Deviation 30.68 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 480 | 6.94 Picogram per milliliter | Standard Deviation 16 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 120 | 13.62 Picogram per milliliter | Standard Deviation 31.54 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 120 | 11.35 Picogram per milliliter | Standard Deviation 27.02 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 150 | 12.01 Picogram per milliliter | Standard Deviation 32.98 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 240 | 13.19 Picogram per milliliter | Standard Deviation 26.27 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 1 | 11.13 Picogram per milliliter | Standard Deviation 24.15 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 420 | 9.89 Picogram per milliliter | Standard Deviation 28.01 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 60 | 24.82 Picogram per milliliter | Standard Deviation 50.09 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 420 | 6.09 Picogram per milliliter | Standard Deviation 22.85 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 660 | 7.09 Picogram per milliliter | Standard Deviation 33.26 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 210 | 10.08 Picogram per milliliter | Standard Deviation 32.66 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 300 | 12.21 Picogram per milliliter | Standard Deviation 22.64 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 180 | 12.66 Picogram per milliliter | Standard Deviation 27.27 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 60 | 15.27 Picogram per milliliter | Standard Deviation 38.72 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 540 | 5.05 Picogram per milliliter | Standard Deviation 14.19 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 240 | 8.83 Picogram per milliliter | Standard Deviation 20.44 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 15.34 Picogram per milliliter | Standard Deviation 37.22 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 720 | 7.70 Picogram per milliliter | Standard Deviation 29.7 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 360 | 12.08 Picogram per milliliter | Standard Deviation 30.02 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 180 | 13.11 Picogram per milliliter | Standard Deviation 30.57 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 4.53 Picogram per milliliter | Standard Deviation 15.68 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 360 | 11.93 Picogram per milliliter | Standard Deviation 22.97 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 540 | 4.36 Picogram per milliliter | Standard Deviation 11.09 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 300 | 12.68 Picogram per milliliter | Standard Deviation 25 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 390 | 72.92 Picogram per milliliter | Standard Deviation 220.09 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 60 | 33.21 Picogram per milliliter | Standard Deviation 51.41 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 240 | 28.11 Picogram per milliliter | Standard Deviation 66.93 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 1 | 22.23 Picogram per milliliter | Standard Deviation 56.62 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 300 | 55.96 Picogram per milliliter | Standard Deviation 142.05 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 1 | 19.14 Picogram per milliliter | Standard Deviation 46.75 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 300 | 57.44 Picogram per milliliter | Standard Deviation 156.63 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | 43.1 Picogram per milliliter | Standard Deviation 114.46 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 360 | 66.16 Picogram per milliliter | Standard Deviation 194.92 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 360 | 62.57 Picogram per milliliter | Standard Deviation 164.16 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 480 | 37.13 Picogram per milliliter | Standard Deviation 98.93 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 720 | 33.11 Picogram per milliliter | Standard Deviation 144.3 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 420 | 54.91 Picogram per milliliter | Standard Deviation 131.76 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 150 | 43.57 Picogram per milliliter | Standard Deviation 125.33 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 420 | 64.51 Picogram per milliliter | Standard Deviation 162.91 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 660 | 26.21 Picogram per milliliter | Standard Deviation 106.89 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 480 | 30.32 Picogram per milliliter | Standard Deviation 91.79 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | 41.53 Picogram per milliliter | Standard Deviation 89.72 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 60 | 60.77 Picogram per milliliter | Standard Deviation 210.62 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 540 | 36.62 Picogram per milliliter | Standard Deviation 87.98 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 540 | 26.73 Picogram per milliliter | Standard Deviation 70.63 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 180 | 41.39 Picogram per milliliter | Standard Deviation 77.77 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 120 | 14.86 Picogram per milliliter | Standard Deviation 37.79 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 180 | 21.64 Picogram per milliliter | Standard Deviation 43.59 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 210 | 24.06 Picogram per milliliter | Standard Deviation 57.43 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 240 | 35.47 Picogram per milliliter | Standard Deviation 83.01 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 120 | 32.26 Picogram per milliliter | Standard Deviation 56.72 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 240 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 480 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 60 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 120 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 570 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 540 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 540 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 300 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 300 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 150 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 720 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 1 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 1 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 180 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 660 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 210 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 420 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 240 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 420 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 360 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 360 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 390 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 180 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 60 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 2 Hours Day 120 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | 0 Hour Day 480 | NA Picogram per milliliter | — |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-42 (Aβ1-42) | Day 90 | NA Picogram per milliliter | — |
Secondary
Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x)
Time frame: 0 Hour (pre-dose) and 2 hours on Day 1, 60, 120, 180, 240, 300, 360, 420, 480, 540; Day 90, 150, 210, 390, 570, 660, 720
Population: FAS included all randomized participants who had received at least 1 infusion of study medication. Here 'Number Analyzed' signifies participants evaluable at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 180 | 3017.50 Picogram per milliliter | Standard Deviation 1296.78 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 540 | 3163.48 Picogram per milliliter | Standard Deviation 1389.06 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 1 | 2128.73 Picogram per milliliter | Standard Deviation 537.63 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 390 | 4300.82 Picogram per milliliter | Standard Deviation 1647.44 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 60 | 3892.17 Picogram per milliliter | Standard Deviation 1013.64 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 1 | 294.12 Picogram per milliliter | Standard Deviation 95.78 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 4568.64 Picogram per milliliter | Standard Deviation 2097.91 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 540 | 5755.50 Picogram per milliliter | Standard Deviation 3402.11 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 420 | 5090.56 Picogram per milliliter | Standard Deviation 1713.37 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 360 | 5253.18 Picogram per milliliter | Standard Deviation 1802.73 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 300 | 4984.58 Picogram per milliliter | Standard Deviation 1496.74 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 300 | 2963.6 Picogram per milliliter | Standard Deviation 1047.13 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 480 | 2899.17 Picogram per milliliter | Standard Deviation 1058.84 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 720 | 1383.76 Picogram per milliliter | Standard Deviation 449.57 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 150 | 4531.25 Picogram per milliliter | Standard Deviation 1597.31 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 60 | 1828.13 Picogram per milliliter | Standard Deviation 976.47 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 120 | 4425.05 Picogram per milliliter | Standard Deviation 1427.1 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 360 | 3053.04 Picogram per milliliter | Standard Deviation 972.76 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 240 | 5269.05 Picogram per milliliter | Standard Deviation 1614.58 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 180 | 5544.76 Picogram per milliliter | Standard Deviation 2044.34 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 240 | 3085.20 Picogram per milliliter | Standard Deviation 1190.23 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 480 | 5196.19 Picogram per milliliter | Standard Deviation 1676.54 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 120 | 2440.00 Picogram per milliliter | Standard Deviation 1054.77 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 3997.20 Picogram per milliliter | Standard Deviation 1322.48 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 420 | 3123.19 Picogram per milliliter | Standard Deviation 1245.1 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 660 | 2422.29 Picogram per milliliter | Standard Deviation 1956.43 |
| PF-04360365 0.1 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 210 | 4673.33 Picogram per milliliter | Standard Deviation 1524 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 60 | 8122.40 Picogram per milliliter | Standard Deviation 2209.66 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 300 | 14710.45 Picogram per milliliter | Standard Deviation 6472.62 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 360 | 14153.16 Picogram per milliliter | Standard Deviation 6473.23 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 300 | 15878.00 Picogram per milliliter | Standard Deviation 7211.88 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 360 | 14313.81 Picogram per milliliter | Standard Deviation 6254.35 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 180 | 16894.78 Picogram per milliliter | Standard Deviation 5283.81 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 660 | 8181.11 Picogram per milliliter | Standard Deviation 7497.62 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 210 | 25108.33 Picogram per milliliter | Standard Deviation 8120.77 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 420 | 14675.24 Picogram per milliliter | Standard Deviation 6367.51 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 420 | 14711.58 Picogram per milliliter | Standard Deviation 5023.57 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 540 | 15516.00 Picogram per milliliter | Standard Deviation 6002.06 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 22257.14 Picogram per milliliter | Standard Deviation 10734.97 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 720 | 3773.5 Picogram per milliliter | Standard Deviation 2447.14 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 1 | 229.68 Picogram per milliliter | Standard Deviation 112.23 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 540 | 14449.47 Picogram per milliliter | Standard Deviation 6474.26 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 1 | 2106.50 Picogram per milliliter | Standard Deviation 480.76 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 60 | 9645.22 Picogram per milliliter | Standard Deviation 1953.32 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 20476.00 Picogram per milliliter | Standard Deviation 5034.49 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 120 | 11435.00 Picogram per milliliter | Standard Deviation 3379.92 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 480 | 16105.79 Picogram per milliliter | Standard Deviation 7332.47 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 120 | 12988.80 Picogram per milliliter | Standard Deviation 4021.06 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 150 | 23600.00 Picogram per milliliter | Standard Deviation 6871.74 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 480 | 13864.29 Picogram per milliliter | Standard Deviation 6772.94 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 180 | 14386.00 Picogram per milliliter | Standard Deviation 5203.12 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 240 | 15445.83 Picogram per milliliter | Standard Deviation 5718.03 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 390 | 19984.76 Picogram per milliliter | Standard Deviation 7108.94 |
| PF-04360365 0.5 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 240 | 15930.91 Picogram per milliliter | Standard Deviation 6681.72 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 60 | 16952.50 Picogram per milliliter | Standard Deviation 4358.13 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 540 | 32468.13 Picogram per milliliter | Standard Deviation 14928.53 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 480 | 29448.00 Picogram per milliliter | Standard Deviation 11647.42 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 660 | 20496.11 Picogram per milliliter | Standard Deviation 20540.31 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 240 | 25532.50 Picogram per milliliter | Standard Deviation 7102.35 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 150 | 43872.00 Picogram per milliliter | Standard Deviation 10714.22 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 480 | 28064.21 Picogram per milliliter | Standard Deviation 11182.9 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 300 | 28366.67 Picogram per milliliter | Standard Deviation 14592.96 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 360 | 23664.29 Picogram per milliliter | Standard Deviation 11040.37 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 540 | 30778.67 Picogram per milliliter | Standard Deviation 16628.98 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 300 | 28647.83 Picogram per milliliter | Standard Deviation 14306.1 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 420 | 23987.78 Picogram per milliliter | Standard Deviation 9082.14 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 240 | 28520.83 Picogram per milliliter | Standard Deviation 8766.83 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 120 | 22416.00 Picogram per milliliter | Standard Deviation 6636.56 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 720 | 7876.67 Picogram per milliliter | Standard Deviation 5846.23 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 210 | 49676.00 Picogram per milliliter | Standard Deviation 12637.16 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 60 | 15558.40 Picogram per milliliter | Standard Deviation 4994.54 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 390 | 40330.45 Picogram per milliliter | Standard Deviation 13327.52 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 180 | 27118.18 Picogram per milliliter | Standard Deviation 7787.09 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 49461.76 Picogram per milliliter | Standard Deviation 22369.81 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 360 | 27999.13 Picogram per milliliter | Standard Deviation 13280.23 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 180 | 26036.00 Picogram per milliliter | Standard Deviation 7745.58 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 36904.00 Picogram per milliliter | Standard Deviation 12258.21 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 120 | 22260.87 Picogram per milliliter | Standard Deviation 6276.85 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 1 | 2199.87 Picogram per milliliter | Standard Deviation 621.29 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 1 | 355.80 Picogram per milliliter | Standard Deviation 514.9 |
| PF-04360365 1.0 mg/kg (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 420 | 26109.52 Picogram per milliliter | Standard Deviation 13214.13 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 1 | 273.21 Picogram per milliliter | Standard Deviation 96 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 390 | 303.76 Picogram per milliliter | Standard Deviation 125.67 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 210 | 385.27 Picogram per milliliter | Standard Deviation 71.98 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 1 | 282.86 Picogram per milliliter | Standard Deviation 75.09 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 240 | 336.24 Picogram per milliliter | Standard Deviation 47.77 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 341.33 Picogram per milliliter | Standard Deviation 80.25 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 480 | 396.44 Picogram per milliliter | Standard Deviation 98.1 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 180 | 363.61 Picogram per milliliter | Standard Deviation 72.24 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 120 | 340.87 Picogram per milliliter | Standard Deviation 96.43 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 60 | 291.62 Picogram per milliliter | Standard Deviation 108.42 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 240 | 327.29 Picogram per milliliter | Standard Deviation 67.08 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 180 | 367.55 Picogram per milliliter | Standard Deviation 63.64 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 120 | 361.80 Picogram per milliliter | Standard Deviation 53.92 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 360 | 287.90 Picogram per milliliter | Standard Deviation 103.73 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 480 | 339.16 Picogram per milliliter | Standard Deviation 86.94 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 150 | 360.30 Picogram per milliliter | Standard Deviation 74.99 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 300 | 297.20 Picogram per milliliter | Standard Deviation 97.78 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 420 | 318.88 Picogram per milliliter | Standard Deviation 61.86 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 720 | 419.11 Picogram per milliliter | Standard Deviation 143.12 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 660 | 421.71 Picogram per milliliter | Standard Deviation 140.09 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 540 | 387.65 Picogram per milliliter | Standard Deviation 119.66 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 60 | 332.46 Picogram per milliliter | Standard Deviation 94.47 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 360 | 277.72 Picogram per milliliter | Standard Deviation 94.14 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 356.71 Picogram per milliliter | Standard Deviation 151.05 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 540 | 359.06 Picogram per milliliter | Standard Deviation 91.66 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 420 | 318.45 Picogram per milliliter | Standard Deviation 76.39 |
| Placebo (Part A) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 300 | 311.43 Picogram per milliliter | Standard Deviation 63.44 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 210 | 84810.71 Picogram per milliliter | Standard Deviation 20382.91 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 60 | 48603.45 Picogram per milliliter | Standard Deviation 20147.32 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 60 | 41772.41 Picogram per milliliter | Standard Deviation 11979.65 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 180 | 55125.00 Picogram per milliliter | Standard Deviation 15273.79 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 180 | 47316.00 Picogram per milliliter | Standard Deviation 15189.79 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 420 | 55273.91 Picogram per milliliter | Standard Deviation 22852.2 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 420 | 54461.90 Picogram per milliliter | Standard Deviation 22287.94 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 540 | 54190.00 Picogram per milliliter | Standard Deviation 20426.89 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 69914.29 Picogram per milliliter | Standard Deviation 19836.82 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 1 | 607.50 Picogram per milliliter | Standard Deviation 765.24 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 1 | 2446.64 Picogram per milliliter | Standard Deviation 1055.11 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 89856.67 Picogram per milliliter | Standard Deviation 20377.45 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 120 | 61270.00 Picogram per milliliter | Standard Deviation 22462.23 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 120 | 49233.33 Picogram per milliliter | Standard Deviation 18308.66 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 150 | 85203.33 Picogram per milliliter | Standard Deviation 21436.55 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 240 | 48344.44 Picogram per milliliter | Standard Deviation 14065.65 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 240 | 47100.00 Picogram per milliliter | Standard Deviation 15547.48 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 300 | 62607.69 Picogram per milliliter | Standard Deviation 21254.16 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 300 | 53808.33 Picogram per milliliter | Standard Deviation 18101.79 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 360 | 58157.69 Picogram per milliliter | Standard Deviation 15871.24 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 360 | 50820.83 Picogram per milliliter | Standard Deviation 16118.2 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 390 | 75133.85 Picogram per milliliter | Standard Deviation 23426.25 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 480 | 75033.33 Picogram per milliliter | Standard Deviation 29410.21 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 480 | 77633.33 Picogram per milliliter | Standard Deviation 35071.25 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 540 | 53154.55 Picogram per milliliter | Standard Deviation 18919.37 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 660 | 28198.18 Picogram per milliliter | Standard Deviation 10933.08 |
| PF-04360365 3.0 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 720 | 14912.65 Picogram per milliliter | Standard Deviation 8037.28 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 240 | 78354.17 Picogram per milliliter | Standard Deviation 28042.48 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 60 | 83050.00 Picogram per milliliter | Standard Deviation 28159.1 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 360 | 84168.42 Picogram per milliliter | Standard Deviation 34779.51 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 240 | 83653.85 Picogram per milliliter | Standard Deviation 28195.07 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 210 | 116703.85 Picogram per milliliter | Standard Deviation 37969.45 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 390 | 114104.35 Picogram per milliliter | Standard Deviation 31087.6 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 1 | 2648.93 Picogram per milliliter | Standard Deviation 695.78 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 420 | 89080.00 Picogram per milliliter | Standard Deviation 25517.79 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 150 | 135288.89 Picogram per milliliter | Standard Deviation 29714.08 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 120 | 91508.70 Picogram per milliliter | Standard Deviation 20558.34 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 60 | 91475.86 Picogram per milliliter | Standard Deviation 22246.33 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 480 | 97239.57 Picogram per milliliter | Standard Deviation 40197.5 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 120 | 110074.07 Picogram per milliliter | Standard Deviation 23932 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 127132.14 Picogram per milliliter | Standard Deviation 25567.72 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 480 | 100941.18 Picogram per milliliter | Standard Deviation 36351.53 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 1 | 337.87 Picogram per milliliter | Standard Deviation 112.84 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 90576.19 Picogram per milliliter | Standard Deviation 60817.37 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 540 | 77400.00 Picogram per milliliter | Standard Deviation 37951.5 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 540 | 94271.43 Picogram per milliliter | Standard Deviation 36384.07 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 420 | 89038.10 Picogram per milliliter | Standard Deviation 31754.61 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 180 | 81960.87 Picogram per milliliter | Standard Deviation 26561.69 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 180 | 93180.00 Picogram per milliliter | Standard Deviation 28531.81 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 720 | 22663.00 Picogram per milliliter | Standard Deviation 14507.34 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 660 | 49011.19 Picogram per milliliter | Standard Deviation 35384.55 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 300 | 79900.00 Picogram per milliliter | Standard Deviation 26477.07 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 360 | 100691.30 Picogram per milliliter | Standard Deviation 37696.25 |
| PF-04360365 8.5 mg/kg (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 300 | 96537.04 Picogram per milliliter | Standard Deviation 44313.44 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 480 | 402.72 Picogram per milliliter | Standard Deviation 195.38 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 60 | 380.90 Picogram per milliliter | Standard Deviation 119.24 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 1 | 382.10 Picogram per milliliter | Standard Deviation 158.9 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 360 | 351.31 Picogram per milliliter | Standard Deviation 105.35 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 240 | 318.37 Picogram per milliliter | Standard Deviation 116.19 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 180 | 297.87 Picogram per milliliter | Standard Deviation 122.91 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 210 | 301.84 Picogram per milliliter | Standard Deviation 110.9 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 660 | 475.46 Picogram per milliliter | Standard Deviation 386.01 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 60 | 405.44 Picogram per milliliter | Standard Deviation 245.46 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 720 | 421.44 Picogram per milliliter | Standard Deviation 170.96 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 390 | 338.79 Picogram per milliliter | Standard Deviation 92.17 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 240 | 350.28 Picogram per milliliter | Standard Deviation 130.39 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 540 | 493.71 Picogram per milliliter | Standard Deviation 251.99 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 420 | 394.04 Picogram per milliliter | Standard Deviation 229.59 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 150 | 363.38 Picogram per milliliter | Standard Deviation 126.56 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 540 | 455.04 Picogram per milliliter | Standard Deviation 201.94 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 120 | 396.10 Picogram per milliliter | Standard Deviation 117.46 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 360 | 353.86 Picogram per milliliter | Standard Deviation 108.68 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 420 | 376.08 Picogram per milliliter | Standard Deviation 172.83 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 300 | 353.24 Picogram per milliliter | Standard Deviation 129.21 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 480 | 356.11 Picogram per milliliter | Standard Deviation 197.3 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 120 | 375.22 Picogram per milliliter | Standard Deviation 118.27 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 570 | 400.58 Picogram per milliliter | Standard Deviation 175.08 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | Day 90 | 386.50 Picogram per milliliter | Standard Deviation 167.65 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 180 | 289.24 Picogram per milliliter | Standard Deviation 139.31 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 2 Hours Day 1 | 380.07 Picogram per milliliter | Standard Deviation 101.11 |
| Placebo (Part B) | Mean Plasma Concentration of Amyloid Beta 1-x (Aβ1-x) | 0 Hour Day 300 | 327.83 Picogram per milliliter | Standard Deviation 112.77 |
Secondary
Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration
Abnormality was defined as concentration either less than lower limit of normal (LLN) or more than upper limit of normal (ULN). Baseline was defined as the last assessment prior to the first study drug infusion
Time frame: Baseline up to Month 24
Population: Safety analysis set included all participants who received an infusion of study medication (including partial infusions). Here Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure and 'Number Analyzed' signifies participants evaluable for specified row.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF RBCs (>ULN) | 2 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Glucose (>ULN) | 2 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF WBCs (>ULN) | 0 Participants |
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Protein (>ULN) | 1 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF RBCs (>ULN) | 2 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Glucose (>ULN) | 0 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Protein (>ULN) | 3 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF WBCs (>ULN) | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF WBCs (>ULN) | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Glucose (>ULN) | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Protein (>ULN) | 1 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF RBCs (>ULN) | 4 Participants |
| Placebo (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Protein (>ULN) | 3 Participants |
| Placebo (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF WBCs (>ULN) | 0 Participants |
| Placebo (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF RBCs (>ULN) | 1 Participants |
| Placebo (Part A) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Glucose (>ULN) | 0 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF RBCs (>ULN) | 6 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Protein (>ULN) | 4 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF WBCs (>ULN) | 2 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Glucose (>ULN) | 2 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF WBCs (>ULN) | 0 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Protein (>ULN) | 4 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF RBCs (>ULN) | 2 Participants |
| PF-04360365 8.5 mg/kg (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Glucose (>ULN) | 2 Participants |
| Placebo (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF WBCs (>ULN) | 0 Participants |
| Placebo (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Protein (>ULN) | 4 Participants |
| Placebo (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF Glucose (>ULN) | 3 Participants |
| Placebo (Part B) | Number of Participants With Abnormal Cerebrospinal Fluid (CSF) Protein, Red Blood Cells (RBCs), White Blood Cells (WBCs), and Glucose Concentration | CSF RBCs (>ULN) | 5 Participants |
Secondary
Number of Participants With Serum Anti-Drug Anti Body (ADA)
Serum samples were analyzed for the presence or absence of anti-PF-04360365 antibodies using validated semi-quantitative enzyme linked immunosorbent assay (ELISA). Only participants receiving PF-04360365 were analyzed for this outcome measure.
Time frame: Day 1 up to Month 24
Population: Safety analysis set included all participants who received an infusion of study medication (including partial infusions).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-04360365 0.1 mg/kg (Part A) | Number of Participants With Serum Anti-Drug Anti Body (ADA) | 0 Participants |
| PF-04360365 0.5 mg/kg (Part A) | Number of Participants With Serum Anti-Drug Anti Body (ADA) | 0 Participants |
| PF-04360365 1.0 mg/kg (Part A) | Number of Participants With Serum Anti-Drug Anti Body (ADA) | 0 Participants |
| Placebo (Part A) | Number of Participants With Serum Anti-Drug Anti Body (ADA) | 0 Participants |
| PF-04360365 3.0 mg/kg (Part B) | Number of Participants With Serum Anti-Drug Anti Body (ADA) | 0 Participants |