AAB-001 in Patients With Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and tolerability of multiple doses of AAB-001 passive immunization in patients with mild to moderate Alzheimer's disease (AD).

Detailed Description
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The humanized monoclonal antibody, AAB-001, which binds to and clears beta amyloid peptide, is designed to provide antibodies to beta amyloid directly to the patient, rather than requiring the patient to mount his/her own individual response. It is believed that this approach may eliminate the need for the patient to mount an immune response to beta amyloid. Animal studies have shown that this approach is equally effective in clearing beta amyloid from the brain as traditional active immunization methods. This is a multicenter, double-blind, placebo controlled, randomized, outpatient, multiple ascending dose study in male and female patients aged 50 to 85 years with mild to moderate AD. Approximately 30 study sites will be involved. Patients will be randomized to receive either AAB-001 or placebo. Each patient's participation will last approximately 2 years.

Official Title
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A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: bapineuzumab
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of probable AD Age from 50 to 85 years Rosen Modified Hachinski Ischemic score less than or equal to 4 Magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD Fluency in English Stable doses of medications Exclusion Criteria: Significant neurological disease other than AD Major psychiatric disorder Significant systemic illness History of stroke or seizure Weight greater than 120 kg (264 lbs.) History of autoimmune disease Smoking more than 20 cigarettes per day Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications Prior treatment with experimental immunotherapeutics or vaccines for AD Presence of pacemakers or foreign metal objects in the eyes, skin, or body

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 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: 0.15 mg/kg active bapineuzumab<br> | Drug: bapineuzumab<br>* IV, Q13w<br>* Other names: AAB-001;|
| Placebo Comparator: 0.15 mg/kg placebo<br> | Other: placebo<br>* IV Q13w<br>|
| Experimental: 0.5 mg/kg active bapineuzumab<br> | Drug: bapineuzumab<br>* IV, Q13w<br>* Other names: AAB-001;|
| Placebo Comparator: 0.5 mg/kg placebo<br> | Other: placebo<br>* IV Q13w<br>|
| Experimental: 1.0 mg/kg active bapineuzumab<br> | Drug: bapineuzumab<br>* IV, Q13w<br>* Other names: AAB-001;|
| Placebo Comparator: 1.0 mg/kg placebo<br> | Other: placebo<br>* IV Q13w<br>|
| Experimental: 2.0 mg/kg active bapineuzumab<br> | Drug: bapineuzumab<br>* IV, Q13w<br>* Other names: AAB-001;|
| Placebo Comparator: 2.0 mg/kg placebo<br> | Other: placebo<br>* IV Q13w<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety assessments |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood levels of administered study drug |  | 18 months | 
| cognitive and functional assessments |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease, immunotherapy, beta amyloid