Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease

Study Overview
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Brief Summary
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This study in individuals with early Alzheimer's disease is designed to assess:(1) safety and tolerability (2) the capacity of ACC-001 and QS-21 adjuvant to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Official Title
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A Phase 2, Multicenter, 24-month, Randomized, Third-party Unblinded, Placebo-controlled, Parallel-group Amyloid Imaging Positron Emission Tomography (Pet) And Safety Trial Of Acc-001 And Qs-21 Adjuvant In Subjects With Early Alzheimer's Disease.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: ACC-001 3 μg/ QS-21 50 μg
* Biological: ACC-001 10 μg/ QS-21 50 μg
* Other: Placebo- Phosphate buffered saline (PBS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Concern about a change in cognition expressed by the subject or by an informant that knows the subject well Mini-Mental State Examination (MMSE) score ≥ 25 Global Clinical Dementia Rating = 0.5. General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer's dementia cannot not be made by the site physician at the time of screening. Amyloid burden detected on screening brain PET scan. Other inclusion criteria apply. Exclusion Criteria: Significant neurological disease other than early Alzheimer's disease Major psychiatric disorder or symptom Contraindication to undergo brain MRI Unstable medical conditions Other exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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 3 μg/ QS-21 50 μg<br> | Biological: ACC-001 3 μg/ QS-21 50 μg<br>* ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18<br>* Other names: Vanutide Cridificar;|
| Experimental: ACC-001 10 μg/ QS-21 50 μg<br> | Biological: ACC-001 10 μg/ QS-21 50 μg<br>* ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18<br>* Other names: Vanutide Cridificar;|
| Placebo Comparator: Placebo- Phosphate buffered saline (PBS)<br> | Other: Placebo- Phosphate buffered saline (PBS)<br>* Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) at Week 104 as Measured by Standard Uptake Value Ratios (SUVRs) Over the Composite Regions of Interest (ROIs) | Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline. | 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Alzheimer's disease, active immunization, amyloid imaging