The purpose of this study is to assess the long-term safety and tolerability of Bapineuzumab (AAB-001, ELN115727) in subjects with Alzheimer's disease who participated in study ELN115727-301 or study ELN115727-302.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
896
0.5 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years. 1.0 mg/kg, administered via IV (in the vein) infusion every 13 weeks for 4 years.
Clinically important changes in safety assessment results including vital signs, weight, clinical laboratory tests, electrocardiograms (ECGs), brain magnetic resonance imaging (MRI), physical and neurological examinations, and infusion site assessments.
Time frame: Varies according to assessment: vital signs and adverse events on ongoing basis; MRI and ECG as required per protocol
To evaluate the efficacy of long term treatment of IV administered bapineuzumab in subjects with AD.
Time frame: The trial duration is expected to be approximately 4 years. The study will last up to the time of commercial launch of bapineuzumab, or termination of the clinical trials program, whichever comes first
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University of Alabama Hospital
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
University of Arizona College of Medicine, Health Sciences 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 181 more locations