Alzheimer's Disease
Conditions
Brief summary
The purpose of this study is to assess the safety, tolerability, and immunogenicity of ACC-001, an investigational vaccine, in subjects with mild to moderate Alzheimer's disease in Japan.
Interventions
Sponsors
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of mild to moderate Alzheimer's Disease * Mini-Mental State Examination (MMSE) 16-26
Exclusion criteria
* Significant Neurological Disease other than Alzheimer's disease * Major psychiatric disorder * Clinically significant systemic illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Baseline up to 24 months | Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function) |
| Number of Participants With Abnormalities in Neurological Examination | Baseline up to 24 months | Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg. |
| Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Baseline up to 24 months | Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-a-beta IgG Titer at Specified Visits | Baseline up to 24 months | Geometric mean of anti-a-beta IgG titer from pre-study through Week 104 |
| Anti-a-beta IgM Titer at Specified Visits | Baseline up to 24 months | Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104 |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Baseline up to 24 months | The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction. |
| The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Baseline up to 24 months | The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment. |
| The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Baseline up to 24 months | The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y\_visit - y\_base)/SD\_base, where y\_visit is a value at a particular time point and y\_base is the average test score, and SD\_base is the SD based on all participants' observed baseline scores in the study. |
| The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Baseline up to 24 months | The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ACC-001 3 Micrograms + QS-21 A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 | 6 |
| ACC-001 10 Micrograms + QS-21 A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 | 9 |
| ACC-001 30 Micrograms + QS-21 A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 | 9 |
| QS-21 A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12 | 8 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 1 | 0 |
| Overall Study | Caregiver Request | 0 | 0 | 2 | 1 |
| Overall Study | Investigator Request | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | ACC-001 3 Micrograms + QS-21 | ACC-001 10 Micrograms + QS-21 | ACC-001 30 Micrograms + QS-21 | QS-21 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 72.50 years STANDARD_DEVIATION 8.73 | 68.00 years STANDARD_DEVIATION 10.34 | 74.33 years STANDARD_DEVIATION 6.69 | 64.75 years STANDARD_DEVIATION 7.15 | 69.81 years STANDARD_DEVIATION 8.83 |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 6 Participants | 7 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants | 1 Participants | 7 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 | 6 / 6 | 8 / 9 | 9 / 9 | 7 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 9 | 0 / 9 | 0 / 8 |
Outcome results
Primary
Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)
Time frame: Baseline up to 24 months
Population: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Mild | 4 Participants |
| ACC-001 3 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Severe | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Moderate | 2 Participants |
| ACC-001 10 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Mild | 7 Participants |
| ACC-001 10 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Severe | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Moderate | 1 Participants |
| ACC-001 30 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Moderate | 1 Participants |
| ACC-001 30 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Mild | 7 Participants |
| ACC-001 30 Micrograms + QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Severe | 1 Participants |
| QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Mild | 5 Participants |
| QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Severe | 0 Participants |
| QS-21 | Incidence of Treatment-emergent Adverse Events (AEs) by Severity | Moderate | 2 Participants |
Primary
Number of Participants With Abnormalities in Neurological Examination
Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.
Time frame: Baseline up to 24 months
Population: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Motor | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Cranial Nerves | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Romberg | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Gate | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Tendon reflexes | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Visual Field | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Speech | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Mental Status | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Coordination | 0 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Sensory | 1 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Total | 1 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Primitive reflexes | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Mental Status | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Motor | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Total | 1 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Gate | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Coordination | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Speech | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Tendon reflexes | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Cranial Nerves | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Romberg | 1 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Visual Field | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Primitive reflexes | 0 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Sensory | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Gate | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Total | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Mental Status | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Speech | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Cranial Nerves | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Visual Field | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Sensory | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Motor | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Coordination | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Primitive reflexes | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Tendon reflexes | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Abnormalities in Neurological Examination | Romberg | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Sensory | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Visual Field | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Total | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Primitive reflexes | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Cranial Nerves | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Speech | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Romberg | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Tendon reflexes | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Mental Status | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Coordination | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Motor | 0 Participants |
| QS-21 | Number of Participants With Abnormalities in Neurological Examination | Gate | 0 Participants |
Primary
Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.
Time frame: Baseline up to 24 months
Population: The safety analysis population includes all of the randomly assigned participants who took at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Abnormal - inconsistent with AD | 1 Participants |
| ACC-001 3 Micrograms + QS-21 | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Abnormal - consistent with AD | 6 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Abnormal - consistent with AD | 9 Participants |
| ACC-001 10 Micrograms + QS-21 | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Abnormal - inconsistent with AD | 0 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Abnormal - inconsistent with AD | 2 Participants |
| ACC-001 30 Micrograms + QS-21 | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Abnormal - consistent with AD | 9 Participants |
| QS-21 | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Abnormal - inconsistent with AD | 0 Participants |
| QS-21 | Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data | Abnormal - consistent with AD | 8 Participants |
Secondary
Anti-a-beta IgG Titer at Specified Visits
Geometric mean of anti-a-beta IgG titer from pre-study through Week 104
Time frame: Baseline up to 24 months
Population: The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Pre-study (n=6,9,9,8) | 50.0 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 10 (n=6,9,9,8) | 979.2 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 50 (n=6,8,7,8) | 1854.5 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 40 (n=5,9,8,8) | 3136.4 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 30 (n=6,9,7,8) | 7218.7 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 14 (n=6,9,9,8) | 6088.4 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 54 (n=5,8,7,7) | 2873.6 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 104 (n=0,1,1,0) | NA Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 78 (n=4,8,6,7) | 5108.6 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 16 (n=6,9,9,8) | 3860.4 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 2 (n=6,9,9,8) | 62.2 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 4 (n=6,9,9,8) | 107.9 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 91 (n=0,1,1,0) | NA Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 24 (n=6,9,9,8) | 1151.5 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 8 (n=6,9,9,8) | 1143.3 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 6 (n=6,9,9,8) | 2106.5 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 66 (n=4,8,7,7) | 7407.9 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 28 (n=6,9,7,8) | 8216.5 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 56 (n=4,8,7,7) | 11006.2 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 28 (n=6,9,7,8) | 8929.3 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 56 (n=4,8,7,7) | 7582.4 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 30 (n=6,9,7,8) | 7017.4 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 91 (n=0,1,1,0) | 546.0 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 40 (n=5,9,8,8) | 2706.5 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 54 (n=5,8,7,7) | 9636.4 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 50 (n=6,8,7,8) | 1255.8 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 6 (n=6,9,9,8) | 4793.2 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 8 (n=6,9,9,8) | 2331.4 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 2 (n=6,9,9,8) | 65.0 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 10 (n=6,9,9,8) | 1674.9 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Pre-study (n=6,9,9,8) | 50.0 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 78 (n=4,8,6,7) | 2465.3 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 14 (n=6,9,9,8) | 6286.2 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 16 (n=6,9,9,8) | 4170.4 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 66 (n=4,8,7,7) | 3942.5 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 24 (n=6,9,9,8) | 1455.0 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 4 (n=6,9,9,8) | 94.2 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 104 (n=0,1,1,0) | 414.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 78 (n=4,8,6,7) | 1316.3 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Pre-study (n=6,9,9,8) | 50.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 2 (n=6,9,9,8) | 67.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 4 (n=6,9,9,8) | 79.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 6 (n=6,9,9,8) | 5702.6 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 8 (n=6,9,9,8) | 3423.9 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 10 (n=6,9,9,8) | 2012.4 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 14 (n=6,9,9,8) | 9983.5 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 16 (n=6,9,9,8) | 9228.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 24 (n=6,9,9,8) | 3903.1 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 28 (n=6,9,7,8) | 7429.5 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 30 (n=6,9,7,8) | 6162.2 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 40 (n=5,9,8,8) | 3615.5 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 50 (n=6,8,7,8) | 1261.4 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 54 (n=5,8,7,7) | 8604.6 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 56 (n=4,8,7,7) | 6201.5 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 66 (n=4,8,7,7) | 2452.5 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 91 (n=0,1,1,0) | 389.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 104 (n=0,1,1,0) | 285.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 28 (n=6,9,7,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 2 (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 56 (n=4,8,7,7) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 24 (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 16 (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Pre-study (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 66 (n=4,8,7,7) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 14 (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 10 (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 8 (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 78 (n=4,8,6,7) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 6 (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 4 (n=6,9,9,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 104 (n=0,1,1,0) | NA Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 50 (n=6,8,7,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 40 (n=5,9,8,8) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 91 (n=0,1,1,0) | NA Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 54 (n=5,8,7,7) | 50.0 Units/mL |
| QS-21 | Anti-a-beta IgG Titer at Specified Visits | Week 30 (n=6,9,7,8) | 50.0 Units/mL |
Secondary
Anti-a-beta IgM Titer at Specified Visits
Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104
Time frame: Baseline up to 24 months
Population: The population for immunogenicity analysis includes all of the randomly assigned participants who took at least one dose of study medication, having the baseline and at least one post baseline immunogenicity evaluation.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Pre-study (n=6,9,9,8) | 30.9 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 10 (n=6,9,9,8) | 850.8 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 50 (n=6,8,7,8) | 354.2 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 40 (n=5,9,8,8) | 449.0 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 30 (n=6,9,7,8) | 859.5 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 14 (n=6,9,9,8) | 1487.6 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 54 (n=5,8,7,7) | 680.7 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 104 (n=0,1,1,0) | NA Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 78 (n=4,8,6,7) | 952.8 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 16 (n=6,9,9,8) | 1503.2 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 2 (n=6,9,9,8) | 77.1 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 4 (n=6,9,9,8) | 108.5 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 91 (n=0,1,1,0) | NA Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 24 (n=6,9,9,8) | 898.5 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 8 (n=6,9,9,8) | 848.6 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 6 (n=6,9,9,8) | 953.2 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 66 (n=4,8,7,7) | 1213.0 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 28 (n=6,9,7,8) | 885.9 Units/mL |
| ACC-001 3 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 56 (n=4,8,7,7) | 1768.3 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 28 (n=6,9,7,8) | 3395.8 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 56 (n=4,8,7,7) | 2570.6 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 30 (n=6,9,7,8) | 3729.9 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 91 (n=0,1,1,0) | 219.0 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 40 (n=5,9,8,8) | 2480.5 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 54 (n=5,8,7,7) | 2605.4 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 50 (n=6,8,7,8) | 1330.0 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 6 (n=6,9,9,8) | 2988.4 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 8 (n=6,9,9,8) | 2940.1 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 2 (n=6,9,9,8) | 92.0 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 10 (n=6,9,9,8) | 2432.1 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Pre-study (n=6,9,9,8) | 28.2 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 78 (n=4,8,6,7) | 1650.3 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 14 (n=6,9,9,8) | 2231.0 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 16 (n=6,9,9,8) | 2484.8 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 66 (n=4,8,7,7) | 1872.7 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 24 (n=6,9,9,8) | 1421.8 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 4 (n=6,9,9,8) | 141.5 Units/mL |
| ACC-001 10 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 104 (n=0,1,1,0) | 154.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 78 (n=4,8,6,7) | 844.9 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Pre-study (n=6,9,9,8) | 25.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 2 (n=6,9,9,8) | 53.5 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 4 (n=6,9,9,8) | 108.5 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 6 (n=6,9,9,8) | 2381.4 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 8 (n=6,9,9,8) | 2776.2 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 10 (n=6,9,9,8) | 2323.9 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 14 (n=6,9,9,8) | 4438.5 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 16 (n=6,9,9,8) | 4590.6 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 24 (n=6,9,9,8) | 2396.4 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 28 (n=6,9,7,8) | 3592.8 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 30 (n=6,9,7,8) | 2956.7 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 40 (n=5,9,8,8) | 1967.3 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 50 (n=6,8,7,8) | 1326.8 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 54 (n=5,8,7,7) | 3017.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 56 (n=4,8,7,7) | 3051.9 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 66 (n=4,8,7,7) | 1825.1 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 91 (n=0,1,1,0) | 351.0 Units/mL |
| ACC-001 30 Micrograms + QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 104 (n=0,1,1,0) | 258.0 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 28 (n=6,9,7,8) | 42.1 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 2 (n=6,9,9,8) | 42.4 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 56 (n=4,8,7,7) | 40.5 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 24 (n=6,9,9,8) | 40.1 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 16 (n=6,9,9,8) | 40.5 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Pre-study (n=6,9,9,8) | 41.5 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 66 (n=4,8,7,7) | 46.0 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 14 (n=6,9,9,8) | 37.6 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 10 (n=6,9,9,8) | 36.1 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 8 (n=6,9,9,8) | 46.9 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 78 (n=4,8,6,7) | 48.3 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 6 (n=6,9,9,8) | 43.0 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 4 (n=6,9,9,8) | 43.7 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 104 (n=0,1,1,0) | NA Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 50 (n=6,8,7,8) | 39.9 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 40 (n=5,9,8,8) | 37.8 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 91 (n=0,1,1,0) | NA Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 54 (n=5,8,7,7) | 48.3 Units/mL |
| QS-21 | Anti-a-beta IgM Titer at Specified Visits | Week 30 (n=6,9,7,8) | 38.9 Units/mL |
Other Pre-specified
The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104.
The ADAS-Cog is a 12-item,objective measure of cognitive function, consisting of 1) Word Recall, 2) Naming Objects and Fingers, 3) Following Commands, 4) Constructional Praxis, 5) Ideational Praxis, 6) Orientation, 7) Word Recognition, 8) Recall of Test Instructions, 9) Spoken Language Ability, 10) Word-Finding Difficulty, 11) Comprehension of Spoken Language and 12) Concentration/Distractibility. For this study, the ADAS-Cog total score is derived by summing the individual scores from items 1 to 11. Total score ranges from 0 to 70 points, with higher scores indicating a greater degree of impairment.
Time frame: Baseline up to 24 months
Population: Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 78 (n=4,8,6,7) | 0.17 Units on a scale | Standard Deviation 3.5 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 26 (n=6,9,9,8) | 0.39 Units on a scale | Standard Deviation 4.38 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 104 (n=0,1,1,0) | NA Units on a scale | — |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 52 (n=5,9,7,8) | 1.87 Units on a scale | Standard Deviation 8.32 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 12 (n=6,9,9,8) | 0.06 Units on a scale | Standard Deviation 5.2 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 52 (n=5,9,7,8) | 0.15 Units on a scale | Standard Deviation 4.82 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 78 (n=4,8,6,7) | 3.40 Units on a scale | Standard Deviation 7.08 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 104 (n=0,1,1,0) | -4.33 Units on a scale | — |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 26 (n=6,9,9,8) | -0.41 Units on a scale | Standard Deviation 5.41 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 12 (n=6,9,9,8) | 0.52 Units on a scale | Standard Deviation 4.39 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 52 (n=5,9,7,8) | 5.05 Units on a scale | Standard Deviation 6.68 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 12 (n=6,9,9,8) | 2.93 Units on a scale | Standard Deviation 4.1 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 26 (n=6,9,9,8) | 3.56 Units on a scale | Standard Deviation 6.74 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 78 (n=4,8,6,7) | 5.39 Units on a scale | Standard Deviation 3.66 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 104 (n=0,1,1,0) | 8.33 Units on a scale | — |
| QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 78 (n=4,8,6,7) | 2.33 Units on a scale | Standard Deviation 7.78 |
| QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 26 (n=6,9,9,8) | -0.63 Units on a scale | Standard Deviation 5.76 |
| QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 12 (n=6,9,9,8) | -0.25 Units on a scale | Standard Deviation 3.3 |
| QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 52 (n=5,9,7,8) | 1.04 Units on a scale | Standard Deviation 7.01 |
| QS-21 | The Mean Changes in Alzheimer's Disease Assessment Scale-Cognitive Behavior (ADAS-Cog) Score From Baseline at Week 12, 26, 52, 78 and 104. | Week 104 (n=0,1,1,0) | NA Units on a scale | — |
Other Pre-specified
The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104.
The DAD is administered through an interview with the caregiver and measures instrumental and basic activities of daily living. A total score is obtained by adding the rating for each question and converting this total score out of 100. Higher scores represent less disability in ADL while lower scores indicate more dysfunction.
Time frame: Baseline up to 24 months
Population: Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 12 (n=5,9,7,8) | -4.7 Units on a scale | Standard Deviation 9.7 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 78 (n=4,8,5,6) | -0.6 Units on a scale | Standard Deviation 3.1 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 52 (n=5,8,6,8) | -11.2 Units on a scale | Standard Deviation 20.9 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 104 (n=0,1,1,0) | NA Units on a scale | — |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 26 (n=6,9,8,8) | -10.1 Units on a scale | Standard Deviation 14.5 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 104 (n=0,1,1,0) | 0 Units on a scale | — |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 12 (n=5,9,7,8) | 0.7 Units on a scale | Standard Deviation 2.6 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 26 (n=6,9,8,8) | -0.2 Units on a scale | Standard Deviation 11.9 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 52 (n=5,8,6,8) | -3.4 Units on a scale | Standard Deviation 10.7 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 78 (n=4,8,5,6) | -5.4 Units on a scale | Standard Deviation 7.7 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 26 (n=6,9,8,8) | -4.4 Units on a scale | Standard Deviation 28.6 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 12 (n=5,9,7,8) | 1.5 Units on a scale | Standard Deviation 5.1 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 104 (n=0,1,1,0) | 12.8 Units on a scale | — |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 78 (n=4,8,5,6) | 0.5 Units on a scale | Standard Deviation 6.9 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 52 (n=5,8,6,8) | -1.8 Units on a scale | Standard Deviation 5.1 |
| QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 104 (n=0,1,1,0) | NA Units on a scale | — |
| QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 52 (n=5,8,6,8) | -3.1 Units on a scale | Standard Deviation 9 |
| QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 78 (n=4,8,5,6) | 3.5 Units on a scale | Standard Deviation 3.2 |
| QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 12 (n=5,9,7,8) | 1.7 Units on a scale | Standard Deviation 6.4 |
| QS-21 | The Mean Changes in Disability Assessment for Dementia (DAD) Score From Baseline at Week 12, 26, 52,78 and 104. | Week 26 (n=6,9,8,8) | -0.6 Units on a scale | Standard Deviation 6.5 |
Other Pre-specified
The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104.
The MMSE is a brief, structured examination of cognitive function. It has a total score of 30 points (0-30), and any score equal to or lower than 26 points indicates cognitive impairment.
Time frame: Baseline up to 24 months
Population: Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 4 (n=6,9,9,8) | 1.7 Units on a scale | Standard Deviation 1.5 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 8 (n=6,9,9,8) | 2.2 Units on a scale | Standard Deviation 3.1 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 12 (n=6,9,9,8) | 0.8 Units on a scale | Standard Deviation 2.8 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 16 (n=6,9,9,8) | 1.5 Units on a scale | Standard Deviation 3.4 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 26 (n=6,9,8,8) | 0.3 Units on a scale | Standard Deviation 3.8 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 30 (n=6,9,8,8) | 0.3 Units on a scale | Standard Deviation 3.7 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 40 (n=4,9,7,8) | 2.3 Units on a scale | Standard Deviation 2.2 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 52 (n=5,8,7,7) | 0.4 Units on a scale | Standard Deviation 4.5 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 78 (n=4,8,6,7) | 1.8 Units on a scale | Standard Deviation 2.5 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 104 (n=0,1,1,0) | NA Units on a scale | — |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 12 (n=6,9,9,8) | 1.1 Units on a scale | Standard Deviation 2.7 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 78 (n=4,8,6,7) | -1.4 Units on a scale | Standard Deviation 3.9 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 16 (n=6,9,9,8) | 1.3 Units on a scale | Standard Deviation 2.3 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 26 (n=6,9,8,8) | 0.1 Units on a scale | Standard Deviation 2.6 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 30 (n=6,9,8,8) | 1.2 Units on a scale | Standard Deviation 2.4 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 40 (n=4,9,7,8) | 0.8 Units on a scale | Standard Deviation 3.5 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 104 (n=0,1,1,0) | -2.0 Units on a scale | — |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 52 (n=5,8,7,7) | 1.0 Units on a scale | Standard Deviation 3.8 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 4 (n=6,9,9,8) | 1.3 Units on a scale | Standard Deviation 1.7 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 8 (n=6,9,9,8) | 0.9 Units on a scale | Standard Deviation 3.2 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 52 (n=5,8,7,7) | 1.1 Units on a scale | Standard Deviation 2.1 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 40 (n=4,9,7,8) | 0.7 Units on a scale | Standard Deviation 2 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 104 (n=0,1,1,0) | -1.0 Units on a scale | — |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 4 (n=6,9,9,8) | 1.6 Units on a scale | Standard Deviation 2.7 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 16 (n=6,9,9,8) | 2.9 Units on a scale | Standard Deviation 2.5 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 30 (n=6,9,8,8) | 1.6 Units on a scale | Standard Deviation 2.4 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 78 (n=4,8,6,7) | -0.3 Units on a scale | Standard Deviation 1.2 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 8 (n=6,9,9,8) | 1.3 Units on a scale | Standard Deviation 1.7 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 26 (n=6,9,8,8) | 1.0 Units on a scale | Standard Deviation 2.8 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 12 (n=6,9,9,8) | 1.1 Units on a scale | Standard Deviation 2 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 26 (n=6,9,8,8) | -0.1 Units on a scale | Standard Deviation 1.6 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 52 (n=5,8,7,7) | 0.6 Units on a scale | Standard Deviation 2.5 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 30 (n=6,9,8,8) | 0.3 Units on a scale | Standard Deviation 3.3 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 104 (n=0,1,1,0) | NA Units on a scale | — |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 40 (n=4,9,7,8) | 0.5 Units on a scale | Standard Deviation 3.2 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 8 (n=6,9,9,8) | 0.9 Units on a scale | Standard Deviation 2.6 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 12 (n=6,9,9,8) | 1.4 Units on a scale | Standard Deviation 2.7 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 16 (n=6,9,9,8) | 0.4 Units on a scale | Standard Deviation 1.8 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 4 (n=6,9,9,8) | 0.4 Units on a scale | Standard Deviation 2.3 |
| QS-21 | The Mean Changes in Mini-Mental State Examination (MMSE) Score From Baseline at Week 4, 8, 12, 16, 26, 30, 40, 52, 78 and 104. | Week 78 (n=4,8,6,7) | 0.0 Units on a scale | Standard Deviation 3.2 |
Other Pre-specified
The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78.
The NTB is a composite of nine widely used neuropsychological tests that assess immediate and delayed recall of verbal and visual information, attention, verbal fluency and executive function. The cognitive tests included in the NTB are the Wechsler Memory Scale (WMS) Visual-Paired Associates (immediate and delayed), WMS-Verbal Paired Associates (immediate and delayed), Rey Auditory Verbal Learning Test (immediate and delayed), WMS-Digit Span, Controlled Word Association Test, and Category Fluency Test. The NTB z-score is used for analysis. The z-score for each component is calculated through the following formula: z = (y\_visit - y\_base)/SD\_base, where y\_visit is a value at a particular time point and y\_base is the average test score, and SD\_base is the SD based on all participants' observed baseline scores in the study.
Time frame: Baseline up to 24 months
Population: Efficacy analyses were performed on the modified intent-to-treat (mITT) population. The mITT population included all of the randomly assigned participants who took at least one dose of study medication, and had the baseline and at least one post baseline evaluation of the key efficacy variable (ADAS-Cog).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 78 (n=4,8,6,7) | -0.088 Z-score | Standard Deviation 0.334 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 26 (n=6,9,9,8) | 0.114 Z-score | Standard Deviation 0.423 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 104 (n=0,1,1,0) | NA Z-score | — |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 52 (n=5,9,7,8) | 0.081 Z-score | Standard Deviation 0.288 |
| ACC-001 3 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 12 (n=6,9,8,8) | 0.023 Z-score | Standard Deviation 0.416 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 52 (n=5,9,7,8) | 0.211 Z-score | Standard Deviation 0.285 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 78 (n=4,8,6,7) | -0.037 Z-score | Standard Deviation 0.494 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 104 (n=0,1,1,0) | 0.514 Z-score | — |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 26 (n=6,9,9,8) | 0.254 Z-score | Standard Deviation 0.353 |
| ACC-001 10 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 12 (n=6,9,8,8) | 0.275 Z-score | Standard Deviation 0.28 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 52 (n=5,9,7,8) | -0.109 Z-score | Standard Deviation 0.263 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 12 (n=6,9,8,8) | -0.028 Z-score | Standard Deviation 0.282 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 26 (n=6,9,9,8) | -0.081 Z-score | Standard Deviation 0.53 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 78 (n=4,8,6,7) | -0.120 Z-score | Standard Deviation 0.442 |
| ACC-001 30 Micrograms + QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 104 (n=0,1,1,0) | -0.559 Z-score | — |
| QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 78 (n=4,8,6,7) | 0.246 Z-score | Standard Deviation 0.336 |
| QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 26 (n=6,9,9,8) | 0.222 Z-score | Standard Deviation 0.308 |
| QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 12 (n=6,9,8,8) | 0.227 Z-score | Standard Deviation 0.107 |
| QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 52 (n=5,9,7,8) | 0.213 Z-score | Standard Deviation 0.416 |
| QS-21 | The Mean Changes in Neuropsychological Test Battery (NTB) Score From Baseline at Week 12, 26, 52 and 78. | Week 104 (n=0,1,1,0) | NA Z-score | — |