Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Official Title
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Phase Iia, Multicenter, Randomized, Third-party Unblinded, Adjuvant-controlled, Multiple Ascending Dose, Safety, Tolerability, And Immunogenicity Trial Of Acc-001 Withqs-21 Adjuvant In Japanese Subjects With Mild To Moderate Alzheimer's Disease.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: ACC-001
* Other: QS-21
* Other: QS-21


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACC-001 + QS-21<br>Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12 | Biological: ACC-001<br>* IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12<br>Other: QS-21<br>* IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12<br>|
| Placebo Comparator: QS-21<br>Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12 | Other: QS-21<br>* IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline up to 24 months | 
| 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. | Baseline up to 24 months | 
| 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. | Baseline up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-a-beta IgG Titer at Specified Visits | Geometric mean of anti-a-beta IgG titer from pre-study through Week 104 | Baseline up to 24 months | 
| Anti-a-beta IgM Titer at Specified Visits | Geotmetric mean of anti-a-beta IgM titer from pre-study through Week 104 | Baseline up to 24 months |