Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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This study in individuals with mild to moderate Alzheimer's Disease is designed to assess:(1) safety and tolerability (2) the capacity of subcutaneous bapineuzumab to reduce brain amyloid load as measured by positron emission tomography (PET) scans.

Official Title
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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center, Biomarker, Safety, and Pharmacokinetic Study of Bapineuzumab (AAB-001) Administered Subcutaneously at Monthly Intervals in Subjects With Mild to Moderate Alzheimer's Disease

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Experimental Bapineuzumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of probable AD Age from 50 to less than 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 or seizure, autoimmune disease, myocardial infarction within the last 2 years Smoking greater than 20 cigarettes per day Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications 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: Bapineuzumab SC Dose 1; 2 mg<br> | Drug: Experimental Bapineuzumab<br>* Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo<br>|
| Experimental: Bapineuzumab SC Dose 2; 7 mg<br> | Drug: Experimental Bapineuzumab<br>* Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo<br>|
| Experimental: Bapineuzumab SC Dose 3; 20 mg<br> | Drug: Experimental Bapineuzumab<br>* Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo<br>|
| Placebo Comparator: Placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of bapineuzumab administered subcutaneously (SC) at monthly intervals compared to placebo on cerebral amyloid burden in subjects with mild to moderate AD. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD |  | 24 months | 
| To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints. |  | 24 months |