Long Term Extension Study Evaluating Safety, Tolerability And Immunogenicity 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 long term extension study is to assess safety, tolerability and immunogenicity of ACC-001 with QS-21 adjuvant in Japanese subjects with mild to moderate AD who were randomized in the preceding P2 double blind studies.

Official Title
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A Phase Iia, Multicenter, Treatment Assigned, Open-label, Long-term Extension Study To Determine Safety, Tolerability, And Immunogenicity Of Acc-001 With Qs-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
* Biological: ACC-001
* Biological: ACC-001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects randomized under previous 3134K1-2202-JA (NCT00752232) and 3134K1-2206-JA (NCT00959192) and met all inclusion criteria and non of the exclusion criteria. Screening brain MRI scan is consistent with the diagnosis of AD. MMSE score 10 and above. Exclusion Criteria: Significant neurological diseases other than AD. Brain MRI evidence of vasogenic edema during the preceding studies. Clinically significant illness.

Ages Eligible for Study
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Minimum Age: 52 Years
Maximum Age: 87 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACC-001 (3 micrograms) + QS-21<br>Active vaccine dose of 3 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18 | Biological: ACC-001<br>* IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18<br>|
| Experimental: ACC-001 (10 micrograms) + QS-21<br>Active vaccine dose of 10 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18 | Biological: ACC-001<br>* IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18<br>|
| Experimental: ACC-001 (30 micrograms) + QS-21<br>Active vaccine dose of 30 micrograms +adjuvant, IM injection, at Day 1, month 6, 12 and 18 | Biological: ACC-001<br>* IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Emergent Adverse Events (AEs) by Severity | Number of mild, moderate, and 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 Nerve Function, Cranial Nerve II, Sensory Function, Motor Function, Coordination, Gait and Station, Reflexes and Deep Tendon Reflexes. | Baseline of the preceding studies through 24 months of this study |