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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,331
infusion every 13 weeks for a total of 6 infusions
given by infusion every 13 weeks for a total of 6 infusions.
infusion every 13 weeks for a total of 6 infusions
University of Alabama Hospital (UAB)
Birmingham, Alabama, United States
Dedicated Clinical Research, Inc.
Goodyear, Arizona, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
HOPE Research Institute, LLC
Phoenix, Arizona, United States
Banner Research Institute
Sun City, Arizona, United States
Cognitive and Functional
Time frame: 18 months
Cognitive and Global
Time frame: 18 months
Imaging and biochemical biomarkers of disease status
Time frame: 18 months
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University of Arizona College of Medicine, Health Science Center
Tucson, Arizona, United States
Northwest Neurospecialists, PLLC
Tucson, Arizona, United States
Clinical Trials Inc.
Little Rock, Arkansas, United States
East Bay Physicians Medical Group
Berkeley, California, United States
AVI Clinical Research
Carson, California, United States
...and 241 more locations