A Multiple Dose Study of PF-04360365 In Patients With Mild to Moderate Alzheimer's Disease

A PHASE 2 DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS/ PHARMACODYNAMICS OF PF-04360365 IN MILD TO MODERATE ALZHEIMER'S DISEASE PATIENTS

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945672

Enrollment

Registered

2009-07-24

Start date

2009-08-06

Completion date

2011-06-01

Last updated

2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease amyloid imaging antibody

Brief summary

The purpose of this study is to determine whether multiple dose administration is safe and well tolerated in patients with mild to moderate Alzheimer's Disease.

Interventions

BIOLOGICALPF-04360365 10 mg/kg

10 mg/kg every 90 days (5 total doses)

BIOLOGICALPF-04360365 7.5 mg/kg

10 mg/kg loading dose followed by 7.5 mg/kg monthly maintenance dosing (total of 13 doses)

DRUGplacebo

placebo administered every 90 days or monthly to match experimental treatment arms.

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

* Males or females of non childbearing potential, age \> or = 50. * Diagnosis of probable Alzheimer's disease, consistent with criteria 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 Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	0 hour (pre-dose) on Day 360	—
Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 540: Cohort Q	0 hours (pre-dose) on Day 540	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 540: Cohort M	0 hour (pre-dose) on Day 540	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	0 hour on Day 0 (Day prior to dosing)	A-beta is a peptide fragment of the amyloid precursor protein (found in the brain of participants suffering from of Alzheimer's disease (AD). In this outcome, CSF concentration of 3 variants of A-beta were reported: A-beta (1-X), A-beta (1-40) and A-beta (1-42).
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M	216 hours post-dose on Day 1	—
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M	456 hours post-dose on Day 1	—
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M	0 hour (pre-dose) on Day 30	—
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q	936 hours post-dose on Day 1 (Samples taken on Day 40)	—
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q	1176 hours post-dose on Day 1 (Samples taken on Day 50)	—
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q	1416 hours post-dose on Day 1 (Samples taken on Day 60)	—
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q	0 hour (pre-dose) on Day 90	—
Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	0 hour (pre-dose) on Day 180	—
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 (up to 18 months)	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 are events between first dose of study medication and up to 6 months after last dose (up to 18 months) that were absent before treatment or worsened relative to pre-treatment state. AEs included both serious and non-serious adverse events.
Number of Participants With Change From Baseline in Brain Magnetic Resonance Imaging (MRI) Abnormalities	Baseline up to Month 18	Number of participants with new clinical findings not evident on the baseline scans, such as brain edema, hemorrhage, encephalitis and other pathology (cerebral edema, cerebral/meningeal enhancement, micro hemorrhage, parenchymal hematoma, subarachnoid hemorrhage, subdural hematoma, cortical infarcts, subcortical grey matter infarcts, white matter infarcts and white matter hyper intensities) were assessed from structural magnetic resonance imaging (MRI). Participants with brain abnormality other than those listed above assessed using MRI scan were reported under 'other' category. Only those MRI findings in which at least 1 participant had event, were reported.
Number of Participants With Gadolinium Use in Brain Magnetic Resonance Imaging (MRI)	Baseline up to Month 18	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.
Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline, Month 13	Quantitative amyloid imaging was performed using PET technique using \[11C\] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M.
Mean Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 0	0 hour on Day 0 (Day prior to dosing)	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 1	0 hour (pre-dose) on Day 1	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 1	0.25 hours post-infusion start on Day 1	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 10: Cohort M	216 hours post dose on Day 1 (samples taken on Day 10)	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 20: Cohort M	456 hours post dose on Day 1 (samples taken on Day 20)	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 30: Cohort M	0 hour (pre-dose) on Day 30	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 30: Cohort M	0.25 hours post-infusion start on Day 30	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 40: Cohort Q	936 hours post dose on Day 1 (samples taken on Day 40)	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 50: Cohort Q	1176 hours post dose on Day 1 (samples taken on Day 50)	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 on Day 60: Cohort Q	1416 hours post-dose on Day 1 (samples taken on Day 60)	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hours on Day 60: Cohort M	0 hour (pre-dose) on Day 60	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 60: Cohort M	0.25 hours post-infusion start on Day 60	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 90	0 hour (pre-dose) on Day 90	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 90	0.25 hours post-infusion start on Day 90	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 120: Cohort M	0 hour (pre-dose) on Day 120	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 120: Cohort M	0.25 hours post-infusion start on Day 120	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 150: Cohort M	0 hour (pre-dose) on Day 150	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 150: Cohort M	0.25 hours post-infusion start on Day 150	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 180	0 hour (pre-dose) on Day 180	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 180	0.25 hours post-infusion start on Day 180	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 210: Cohort M	0 hour (pre-dose) on Day 210	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 210: Cohort M	0.25 hours post-infusion start on Day 210	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 240: Cohort M	0 hour (pre-dose) on Day 240	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 240: Cohort M	0.25 hours post-infusion start on Day 240	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 270	0 hour (pre-dose) on Day 270	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 270	0.25 hours post-infusion start on Day 270	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 300: Cohort M	0 hour (pre-dose) on Day 300	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 300: Cohort M	0.25 hours post-infusion start on Day 300	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 330: Cohort M	0 hour (pre-dose) on Day 330	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 330: Cohort M	0.25 hours post-infusion start on Day 330	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma and Cerebrospinal Fluid (CSF) Concentration of PF-04360365 at 0 Hour on Day 360	0 hour (pre-dose) on Day 360	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0.25 Hours on Day 360	0.25 hours post-infusion start on Day 360	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 720 Hours Post-dose on Day 360: Cohort Q	720 hours post-dose on Day 360 (samples taken on Day 390)	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.
Mean Plasma Concentration of PF-04360365 at 0 Hour on Day 390: Cohort M	0 hour (pre-dose) on Day 390	Samples for PF-04360365 concentration were assayed using a validated, sensitive and specific enzyme-linked immunosorbent assay method.

Secondary

Measure	Time frame	Description
Change From Baseline in Mini-Mental State Examination (MMSE) Total Score at Month 13	Baseline, Month 13	Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total MMSE score ranged from 0 (worst cognitive state) to 30 (best cognitive state), where higher score indicates better cognitive state.
Mean Plasma Concentration of Amyloid Beta 1-x (A-beta 1-x)	Cohort M&Q: 0 hour(hr) & 0.25 hrs post dose (pd) on Day (D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936,1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D 60, 0 hr & 0.25 hrs pd on D 30,120,150,210,240,300,330	—
Mean Plasma Concentration of Amyloid Beta 1-40 (A-beta 1-40)	Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390,540; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330	—
Mean Plasma Concentration of Amyloid Beta 1-42 (A-beta 1-42)	Cohort M&Q: 0 hr & 0.25 hrs post dose(pd) on Day(D) 1,90,180,270,360, 0 hr pd on D 60,390; Cohort Q: 936, 1176 hrs pd on D1(D 40,50); Cohort M: 216, 456 hrs pd on D1(D 10,20), 0.25 hrs pd on D60, 0 hr & 0.25 hrs pd on D 30,120,150,210, 240,300,330	—
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-cog) Total Score at Months 3, 6, 9, 13 and 18	Baseline, Month 3, 6, 9, 13, 18	ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's Disease. It comprises 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). The total score was calculated as the sum of the scores for the 11 items. ADAS-cog total score ranges from 0 (no impairment) to 70 (maximum impairment). Higher total and individual item scores indicate greater cognitive impairment.
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Month 6, 13 and 18	Baseline, Month 6, 13, 18	DAD is a functional assessment based on interview with the caregiver of participants. It consists of 40 items, 17 related to self-care and 23 items involving instrumental activities of daily living. Each item scored as yes = 1, no = 0 and not applicable= N/A. A total score is obtained by adding the rating for each question and converting this to a total score out of 100. The items rated N/A are not considered for the total score. DAD total score range from 0 (more dysfunction) to 100 (better function), with higher scores indicating better functioning.

Other

Measure	Time frame	Description
Mean Cerebrospinal Fluid (CSF) Concentration of Total Tau and Phospho-tau (P-tau) Proteins	Cohort M&Q: Pre dose (0 hr) on Day 0, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30	—
Change From Baseline in Red Blood Cells (RBCs) and White Blood Cells (WBCs) Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360	Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30	—
Change From Baseline in Glucose Concentration in Cerebrospinal Fluid (CSF) at Day 10, 20, 30, 40, 50, 60, 90, 180, 360	Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30	—
Number of Participants With Measurable Serum Anti-Drug Antibody (ADA) Concentration	Day 1 up to Month 18	A measurable ADA is defined as a serum anti-drug anti body response (total binding assay) greater than the lower limit of quantification (4.32).
Change From Baseline in Cerebrospinal Fluid (CSF) Protein Concentration at Day 10, 20, 30, 40, 50, 60, 90, 180 and 360	Cohort M&Q: Baseline, 0 hr post dose on Day 180, 360; Cohort Q: 936, 1176 hrs post dose on Day 1(Day 40,50), 0 hr post dose on Day 60, 90; Cohort M: 216, 456 hrs post dose on Day 1(Day 10, 20), 0 hr post dose on Day 30	—

Countries

Sweden

Participant flow

Participants by arm

Arm	Count
PF-04360365 10 mg/kg (Cohort Q) Participants received PF-04360365 10 milligram per kilogram (mg/kg) intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.	12
Placebo (Cohort Q) Participants received placebo matched to PF-04360365 10 mg/kg intravenous infusion over 10 minutes on Day 1 and then once in every 3 months up to a maximum duration of 12 months.	6
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M) Participants received PF-04360365 loading dose of 10 mg/kg intravenous infusion over 10 minutes on Day 1, followed by PF-04360365 7.5 mg/kg intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.	12
Placebo (Cohort M) Participants received placebo matched to PF-04360365 on Day 1, followed by placebo intravenous infusion over 10 minutes every month starting from Month 1 up to 12 months.	6
Total	36

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Withdrawal by Subject	0	0	0	1

Baseline characteristics

Characteristic	PF-04360365 10 mg/kg (Cohort Q)	Placebo (Cohort Q)	PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Placebo (Cohort M)	Total
Age, Continuous	65.1 years STANDARD_DEVIATION 7.4	71.3 years STANDARD_DEVIATION 8.5	69.8 years STANDARD_DEVIATION 7.5	65.8 years STANDARD_DEVIATION 8.3	67.8 years STANDARD_DEVIATION 7.8
Sex: Female, Male Female	4 Participants	3 Participants	3 Participants	5 Participants	15 Participants
Sex: Female, Male Male	8 Participants	3 Participants	9 Participants	1 Participants	21 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	9 / 12	5 / 6	10 / 12	5 / 6
serious Total, serious adverse events	2 / 12	1 / 6	1 / 12	0 / 6

Outcome results

Primary

Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M

Quantitative amyloid imaging was performed using PET technique using \[11C\] Pittsburgh Compound B (PIB) for following brain areas: frontal, temporal, parietal and occipital cortices, anterior and posterior cingular cortex, cerebellum, pons, and subcortical white matter. For target regions of interest, beta-amyloid plaque imaging radiotracer (PIB) retention data was expressed as standard uptake value ratio (SUVR) which was defined as a ratio of radioactivity uptake of the target region relative to the cerebellum reference region. This outcome measure was planned to be analyzed only for cohort M.

Time frame: Baseline, Month 13

Population: Per Protocol (PP) analysis set included all participants who had received the study drug infusions consistent with the protocol specified procedures, had successful PET scans at Month 13, and had no major protocol deviations. Only participants in cohort M were planned to be analyzed for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Frontal Cortex	-0.092 Standard update value ratio	Standard Deviation 0.3081
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Anterior Cingulum	2.723 Standard update value ratio	Standard Deviation 0.6085
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Parietal Cortex	-0.030 Standard update value ratio	Standard Deviation 0.2039
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Lateral Temporal Cortex	2.492 Standard update value ratio	Standard Deviation 0.4945
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Lateral Temporal Cortex	-0.056 Standard update value ratio	Standard Deviation 0.2485
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Temporal Medial	1.557 Standard update value ratio	Standard Deviation 0.1693
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Occipital Cortex	-0.066 Standard update value ratio	Standard Deviation 0.2027
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Cerebellum	1.000 Standard update value ratio	Standard Deviation 0
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Cerebellum	0.000 Standard update value ratio	Standard Deviation 0
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Posterior Cingulum	2.866 Standard update value ratio	Standard Deviation 0.5547
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Striatum	-0.047 Standard update value ratio	Standard Deviation 0.1602
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Parietal Cortex	2.480 Standard update value ratio	Standard Deviation 0.5175
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Anterior Cingulum	-0.103 Standard update value ratio	Standard Deviation 0.2397
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Pons	2.042 Standard update value ratio	Standard Deviation 0.3195
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Temporal Medial	-0.009 Standard update value ratio	Standard Deviation 0.096
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Striatum	2.325 Standard update value ratio	Standard Deviation 0.4351
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Posterior Cingulum	-0.065 Standard update value ratio	Standard Deviation 0.277
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Subcortical White Matter	2.315 Standard update value ratio	Standard Deviation 0.3442
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Pons	-0.026 Standard update value ratio	Standard Deviation 0.2034
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Occipital Cortex	2.085 Standard update value ratio	Standard Deviation 0.4064
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Subcortical White Matter	-0.083 Standard update value ratio	Standard Deviation 0.2047
PF-04360365 10 mg/kg (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Frontal Cortex	2.781 Standard update value ratio	Standard Deviation 0.6769
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Subcortical White Matter	-0.024 Standard update value ratio	Standard Deviation 0.2781
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Frontal Cortex	2.835 Standard update value ratio	Standard Deviation 0.3775
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Parietal Cortex	2.647 Standard update value ratio	Standard Deviation 0.402
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Lateral Temporal Cortex	2.626 Standard update value ratio	Standard Deviation 0.3327
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Occipital Cortex	1.994 Standard update value ratio	Standard Deviation 0.2066
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Cerebellum	1.000 Standard update value ratio	Standard Deviation 0
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Striatum	2.440 Standard update value ratio	Standard Deviation 0.3468
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Anterior Cingulum	2.845 Standard update value ratio	Standard Deviation 0.3109
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Temporal Medial	1.615 Standard update value ratio	Standard Deviation 0.1334
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Posterior Cingulum	2.927 Standard update value ratio	Standard Deviation 0.3624
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Pons	2.091 Standard update value ratio	Standard Deviation 0.3871
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Baseline: Subcortical White Matter	2.407 Standard update value ratio	Standard Deviation 0.318
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Frontal Cortex	-0.096 Standard update value ratio	Standard Deviation 0.3243
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Parietal Cortex	-0.113 Standard update value ratio	Standard Deviation 0.3309
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Lateral Temporal Cortex	-0.094 Standard update value ratio	Standard Deviation 0.2956
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Occipital Cortex	0.047 Standard update value ratio	Standard Deviation 0.2409
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Cerebellum	0.000 Standard update value ratio	Standard Deviation 0
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Striatum	-0.091 Standard update value ratio	Standard Deviation 0.2568
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Anterior Cingulum	-0.068 Standard update value ratio	Standard Deviation 0.3245
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Temporal Medial	-0.025 Standard update value ratio	Standard Deviation 0.2255
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Posterior Cingulum	-0.103 Standard update value ratio	Standard Deviation 0.3539
Placebo (Cohort Q)	Change From Baseline in Amyloid Load at Month 13 Using Positron Emission Tomography (PET) Technique: Cohort M	Change at Month 13: Pons	-0.013 Standard update value ratio	Standard Deviation 0.2181

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0

A-beta is a peptide fragment of the amyloid precursor protein (found in the brain of participants suffering from of Alzheimer's disease (AD). In this outcome, CSF concentration of 3 variants of A-beta were reported: A-beta (1-X), A-beta (1-40) and A-beta (1-42).

Time frame: 0 hour on Day 0 (Day prior to dosing)

Population: Full Analysis Set (FAS) included all randomized participants who received at least 1 infusion of study medication.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-x	31150.00 Picogram per milliliter (pg/mL)	Standard Deviation 9063.66
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-42	1003.75 Picogram per milliliter (pg/mL)	Standard Deviation 358.3
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-40	15794.17 Picogram per milliliter (pg/mL)	Standard Deviation 7569.38
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-x	28533.33 Picogram per milliliter (pg/mL)	Standard Deviation 5269.41
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-42	882.00 Picogram per milliliter (pg/mL)	Standard Deviation 185.95
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-40	13296.67 Picogram per milliliter (pg/mL)	Standard Deviation 2428.35
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-40	11688.33 Picogram per milliliter (pg/mL)	Standard Deviation 3813.4
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-x	30497.50 Picogram per milliliter (pg/mL)	Standard Deviation 16885
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-42	758.67 Picogram per milliliter (pg/mL)	Standard Deviation 204.65
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-x	28500.00 Picogram per milliliter (pg/mL)	Standard Deviation 8696.44
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-42	870.00 Picogram per milliliter (pg/mL)	Standard Deviation 270.25
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 0	A-beta 1-40	12215.00 Picogram per milliliter (pg/mL)	Standard Deviation 2674.13

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180

Time frame: 0 hour (pre-dose) on Day 180

Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here Overall Number of Participants Analyzed signifies participants evaluable for this measure and 'Number Analyzed' signifies participants evaluable for specified amyloid beta for each treatment arm, respectively.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-40	-60.93 pg/mL	Standard Deviation 13.99
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-42	18.57 pg/mL	Standard Deviation 19.99
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-x	-37.94 pg/mL	Standard Deviation 9.81
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-x	-44.49 pg/mL	Standard Deviation 10.99
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-42	-4.18 pg/mL	Standard Deviation 22.66
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-40	-60.42 pg/mL	Standard Deviation 7.98
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-40	179.14 pg/mL	Standard Deviation 121.44
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-x	13.91 pg/mL	Standard Deviation 21.25
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-42	75.58 pg/mL	Standard Deviation 45.47
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-x	-0.57 pg/mL	Standard Deviation 23.16
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-42	-15.77 pg/mL	Standard Deviation 34.09
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 180	A-beta 1-40	147.17 pg/mL	Standard Deviation 126.47

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M

Time frame: 0 hour (pre-dose) on Day 30

Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here Overall Number of Participants Analyzed signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M	A-beta 1-x	0.80 pg/mL	Standard Deviation 31.57
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M	A-beta 1-40	43.33 pg/mL	Standard Deviation 20.67
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M	A-beta 1-42	14.15 pg/mL	Standard Deviation 17.45
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M	A-beta 1-x	-0.79 pg/mL	Standard Deviation 30.68
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M	A-beta 1-40	-17.07 pg/mL	Standard Deviation 19.05
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 30: Cohort M	A-beta 1-42	-13.98 pg/mL	Standard Deviation 12.48

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360

Time frame: 0 hour (pre-dose) on Day 360

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-40	98.33 pg/mL	Standard Deviation 133.77
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-42	-26.70 pg/mL	Standard Deviation 40.32
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-x	-16.70 pg/mL	Standard Deviation 22.23
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-x	-30.01 pg/mL	Standard Deviation 11.85
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-42	-40.24 pg/mL	Standard Deviation 14.77
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-40	35.60 pg/mL	Standard Deviation 122.29
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-40	3.07 pg/mL	Standard Deviation 69.15
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-x	-27.69 pg/mL	Standard Deviation 28.11
PF-04360365 10 mg/kg, Then PF-04360365 7.5 mg/kg (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-42	49.15 pg/mL	Standard Deviation 54.18
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-x	-42.16 pg/mL	Standard Deviation 17.77
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-42	-27.46 pg/mL	Standard Deviation 11.27
Placebo (Cohort M)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 360	A-beta 1-40	56.66 pg/mL	Standard Deviation 90.93

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q

Time frame: 0 hour (pre-dose) on Day 90

Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here Overall Number of Participants Analyzed signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q	A-beta 1-x	-0.51 pg/mL	Standard Deviation 8.96
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q	A-beta 1-40	27.67 pg/mL	Standard Deviation 40.65
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q	A-beta 1-42	-15.62 pg/mL	Standard Deviation 18.01
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q	A-beta 1-x	-15.57 pg/mL	—
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q	A-beta 1-40	-23.23 pg/mL	—
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 0 Hour on Day 90: Cohort Q	A-beta 1-42	-38.65 pg/mL	—

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q

Time frame: 1176 hours post-dose on Day 1 (Samples taken on Day 50)

Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here Overall Number of Participants Analyzed signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q	A-beta 1-x	12.35 pg/mL	Standard Deviation 11.45
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q	A-beta 1-40	-17.98 pg/mL	Standard Deviation 37.02
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q	A-beta 1-42	2.32 pg/mL	Standard Deviation 16.51
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q	A-beta 1-x	-1.60 pg/mL	Standard Deviation 9.02
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q	A-beta 1-40	-6.67 pg/mL	Standard Deviation 9.43
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1176 Hours Post-dose on Day 1: Cohort Q	A-beta 1-42	-3.36 pg/mL	Standard Deviation 18.68

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q

Time frame: 1416 hours post-dose on Day 1 (Samples taken on Day 60)

Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here Overall Number of Participants Analyzed signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q	A-beta 1-x	9.62 pg/mL	Standard Deviation 6.51
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q	A-beta 1-40	27.85 pg/mL	Standard Deviation 35.55
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q	A-beta 1-42	9.52 pg/mL	Standard Deviation 14.31
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q	A-beta 1-x	0.04 pg/mL	Standard Deviation 1.33
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q	A-beta 1-40	-5.61 pg/mL	Standard Deviation 0.44
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 1416 Hours Post-dose on Day 1: Cohort Q	A-beta 1-42	-12.08 pg/mL	Standard Deviation 2.95

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M

Time frame: 216 hours post-dose on Day 1

Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here Overall Number of Participants Analyzed signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M	A-beta 1-x	22.32 pg/mL	Standard Deviation 17.55
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M	A-beta 1-40	9.24 pg/mL	Standard Deviation 44.06
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M	A-beta 1-42	-0.46 pg/mL	Standard Deviation 14.59
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M	A-beta 1-x	-21.21 pg/mL	—
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M	A-beta 1-40	1.43 pg/mL	—
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 216 Hours Post-dose on Day 1: Cohort M	A-beta 1-42	-3.78 pg/mL	—

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M

Time frame: 456 hours post-dose on Day 1

Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here Overall Number of Participants Analyzed signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every month (cohort M) were to be analyzed for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M	A-beta 1-x	-2.38 pg/mL	Standard Deviation 14.01
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M	A-beta 1-40	4.23 pg/mL	Standard Deviation 25.16
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M	A-beta 1-42	8.14 pg/mL	Standard Deviation 31.37
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M	A-beta 1-x	-5.95 pg/mL	—
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M	A-beta 1-40	-8.75 pg/mL	—
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 456 Hours Post-dose on Day 1: Cohort M	A-beta 1-42	-24.57 pg/mL	—

Primary

Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q

Time frame: 936 hours post-dose on Day 1 (Samples taken on Day 40)

Population: FAS included all randomized participants who received at least 1 infusion of PF-04360365. Here Overall Number of Participants Analyzed signifies participants evaluable for this measure. Only participants receiving PF-04360365 or placebo every 3 months (cohort Q) were to be analyzed for this outcome measure.

Arm	Measure	Group	Value (MEAN)	Dispersion
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q	A-beta 1-x	16.78 pg/mL	Standard Deviation 9.69
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q	A-beta 1-40	26.77 pg/mL	Standard Deviation 16.01
PF-04360365 10 mg/kg (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q	A-beta 1-42	17.30 pg/mL	Standard Deviation 14.03
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q	A-beta 1-x	5.05 pg/mL	Standard Deviation 3.71
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q	A-beta 1-40	160.62 pg/mL	Standard Deviation 51.13
Placebo (Cohort Q)	Mean Cerebrospinal Fluid (CSF) Concentration of Amyloid Beta 1-x (A-beta 1-x), Amyloid Beta 1-40 (A-beta 1-40) and Amyloid Beta 1-42 (A-beta 1-42) at 936 Hours Post-dose on Day 1: Cohort Q	A-beta 1-42	-7.40 pg/mL	Standard Deviation 13.74

Primary