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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 1,121
- Locations
- 184
- Primary Endpoint
- Cognitive and Functional
Study 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 88 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Drug)
Placebo Dose
infusion every 13 weeks for a total of 6 infusions.
Intervention: Placebo Control (Drug)
Bapineuzumab 1.0 m/kg
infusion every 13 weeks for a total of 6 infusions.
Intervention: Bapineuzumab 1.0 m/kg (Drug)
Outcomes
Primary Outcomes
Cognitive and Functional
Time Frame: 18 months
Secondary Outcomes
- Imaging and biochemical biomarkers of disease status(18 months)
- Cognitive and Global(18 months)