Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The study is to evaluate the safety, tolerability and whether there is an immune system response to multiple doses of ACC-001 with or without the use of a substance that may increase the response to the drug.

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

Conditions
-----------------
Alzheimer Disease

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mild to moderate Alzheimer's Disease Mini Mental Status Exam (MMSE) of 16-26 Exclusion Criteria: Significant Neurological Disease Major Psychiatric Disorder Clinically significant systemic illness

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial 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, 30 micrograms, Day 1, month 3, 6, 9, 12 | Biological: ACC-001<br>* IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12<br>Other: QS-21<br>* IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12<br>|
| Experimental: ACC-001<br>Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 | Biological: ACC-001<br>* IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12<br>|
| Placebo Comparator: QS-21<br>Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12 | Other: QS-21<br>* IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12<br>|
| Placebo Comparator: PBS<br>Placebo, IM injection, Day 1, month 3, 6, 9, 12 | Other: PBS<br>* IM injection, Day 1, month 3, 6, 9, 12<br>|

What is the study measuring?
-----------------
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 investigator. | 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 | Geometric mean of anti-a-beta IgM titer from pre-study through Week 104 | Baseline up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Phase IIa, multiple ascending dose study of ACC-001