AAB-001 in Patients With Mild to Moderate Alzheimer's Disease
- Registration Number
- NCT00112073
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 234
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.15 mg/kg placebo placebo - 0.5 mg/kg active bapineuzumab bapineuzumab - 0.5 mg/kg placebo placebo - 1.0 mg/kg active bapineuzumab bapineuzumab - 1.0 mg/kg placebo placebo - 2.0 mg/kg placebo placebo - 0.15 mg/kg active bapineuzumab bapineuzumab - 2.0 mg/kg active bapineuzumab bapineuzumab -
- Primary Outcome Measures
Name Time Method safety assessments 18 months
- Secondary Outcome Measures
Name Time Method blood levels of administered study drug 18 months cognitive and functional assessments 18 months
Trial Locations
- Locations (25)
Cleo Roberts Center for Clinical Research / Sun Health Research Institute
🇺🇸Sun City, Arizona, United States
UC Irvine
🇺🇸Irvine, California, United States
Pharmacology Research Institute
🇺🇸Northridge, California, United States
UCSD Shiley-Marcos Alzheimer's Disease Research Center
🇺🇸San Diego, California, United States
Memory & Aging Center, UCSF
🇺🇸San Francisco, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Brain Matters Research, Inc.
🇺🇸Delray Beach, Florida, United States
Mayo Clinic - Department of Neurology
🇺🇸Jacksonville, Florida, United States
Rush Presbyterian St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Scroll for more (15 remaining)Cleo Roberts Center for Clinical Research / Sun Health Research Institute🇺🇸Sun City, Arizona, United States