Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)

Study Overview
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Brief Summary
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This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 200 study sites in the US and Canada will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years. Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Official Title
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Carriers.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Bapineuzumab 0.5 mg/kg
* Drug: Placebo Control
* Drug: Bapineuzumab 1.0 m/kg


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 16-26 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 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: 88 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 0.5 mg/kg<br>infusion every 13 weeks for a total of 6 infusions | Drug: Bapineuzumab 0.5 mg/kg<br>* given by infusion every 13 weeks for a total of 6 infusions.<br>* Other names: AAB-001;|
| Placebo Comparator: Placebo Dose<br>infusion every 13 weeks for a total of 6 infusions. | Drug: Placebo Control<br>* given by infusion every 13 weeks for a total of 6 infusions.<br>|
| Experimental: Bapineuzumab 1.0 m/kg<br>infusion every 13 weeks for a total of 6 infusions. | Drug: Bapineuzumab 1.0 m/kg<br>* given by infusion every 13 weeks for a total of 6 infusions.<br>* Other names: AAB-001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive and Functional |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive and Global |  | 18 months | 
| Imaging and biochemical biomarkers of disease status |  | 18 months |