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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
234
IV, Q13w
IV Q13w
safety assessments
Time frame: 18 months
blood levels of administered study drug
Time frame: 18 months
cognitive and functional assessments
Time frame: 18 months
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Cleo Roberts Center for Clinical Research / Sun Health Research Institute
Sun City, Arizona, United States
UC Irvine
Irvine, California, United States
Pharmacology Research Institute
Los Alamitos, 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 D.C., District of Columbia, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Mayo Clinic - Department of Neurology
Jacksonville, Florida, United States
...and 16 more locations