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 Non- Carriers.
Overview
- Phase
- Phase 3
- Intervention
- Bapineuzumab 0.5 mg/kg
- Conditions
- Alzheimer's Disease
- Sponsor
- JANSSEN Alzheimer Immunotherapy Research & Development, LLC
- Enrollment
- 1331
- Locations
- 247
- Primary Endpoint
- Cognitive and Functional
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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 230 study sites in the US and Canada and up to 35 sites outside of North America 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Bapineuzumab 0.5 mg/kg
infusion every 13 weeks for a total of 6 infusions
Intervention: Bapineuzumab 0.5 mg/kg
Placebo Control
infusion every 13 weeks for a total of 6 infusions.
Intervention: Placebo Control
Bapineuzumab 1.0 m/kg
infusion every 13 weeks for a total of 6 infusions.
Intervention: Bapineuzumab 1.0 m/kg
Outcomes
Primary Outcomes
Cognitive and Functional
Time Frame: 18 months
Secondary Outcomes
- Cognitive and Global(18 months)
- Imaging and biochemical biomarkers of disease status(18 months)