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

Study Overview
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Brief Summary
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A Phase II clinical research study to evaluate the efficacy and safety of two different dose levels of an injectable investigational treatment (ACC-001) in subjects with Mild-to-Moderate Alzheimer's disease. ACC-001 (vanutide cridificar) is a beta amyloid fragment attached to a carrier protein. It is intended to help induce an antibody response against beta amyloid and is administered as an intramuscular injection.

Official Title
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A Phase 2, 24-Month, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Amyloid-Imaging Positron Emission Tomography (PET) and Safety Study of ACC-001 and QS-21 Adjuvant in 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 (vanutide cridificar)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of probable AD Age from 50 to 89 Mini-Mental Status Exam score of 18-26 inclusive Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD Stable doses of medications (cholinesterase inhibitors and memantine allowed) Caregiver able to attend all clinic visits with patient Amyloid burden on screening PET scan consistent with diagnosis of AD Exclusion Criteria: Significant neurological disease other than AD Major psychiatric disorder Significant systemic illness History of stroke, seizure or autoimmune disease History of myocardial infarction within the last 2 years Smoking greater than 20 cigarettes per day Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications (anticonvulsants used for non-seizure reasons are allowed) Prior treatment experimental immunotherapeutics or vaccines for AD Women of childbearing potential Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 89 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: 3 μg ACC-001 / QS-21 50 μg IM dose 1<br>3 μg ACC-001 / QS-21 50 μg IM | Biological: ACC-001 (vanutide cridificar)<br>* Comparisons of 2 different doses of ACC-001 or placebo for 24 months<br>* Other names: vanutide cridificar;|
| Experimental: 10 μg ACC-001 / QS-21 50 μg IM dose 2<br>10 μg ACC-001 / QS-21 50 μg IM | Biological: ACC-001 (vanutide cridificar)<br>* Comparisons of 2 different doses of ACC-001 or placebo for 24 months<br>* Other names: vanutide cridificar;|
| No Intervention: Placebo - Phosphate buffered saline (PBS) IM dose<br>Placebo - Phosphate buffered saline (PBS) IM | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease. |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 vs. placebo in subjects with mild to moderate AD. | As assessed by: The incidence and severity of treatment-emergent adverse events (TEAEs); and Clinically important changes in safety assessment results (vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], and physical and neurological examinations). | 24 Months | 
| Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers. |  | 24 Months | 
| Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity. |  | 24 Months | 
| Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in cognitive and functional scales. |  | 24 Months | 
| Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in health outcome measures. |  | 24 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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injection, vaccine, immunization, amyloid imaging, Mild to moderate Alzheimer's disease