221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Alzheimer's Disease
In brief
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) \[ADAS-Cog 13\], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) \[ADCS-ADL-MCI\].
Key facts
- Study ID
- NCT02484547
- Run by
- Biogen
- People needed
- 1643
- Starts
- 2015-09-15
- Expected to finish
- 2019-08-05
- Last updated by the study team
- 2021-09-02
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Banner Alzheimer's Institute — Phoenix, Arizona, United States
- Xenoscience Inc. — Phoenix, Arizona, United States
- Banner Sun Health Research Institute — Sun City, Arizona, United States
- Institute for Memory Impairments — Irvine, California, United States
- Renewal Behavioral Health — Long Beach, California, United States
- USC Keck School of Medicine — Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
- Excell Research, Inc. — Oceanside, California, United States
- Pacific Neuroscience Medical Group — Oxnard, California, United States
- Anderson Clinical Research — Redlands, California, United States
- Pacific Research Network — San Diego, California, United States
- University of California San Diego Medical Center — San Diego, California, United States
- California Pacific Medical Center — San Francisco, California, United States
- Syrentis Clinical Research — Santa Ana, California, United States
- St Joseph Heritage Healthcare — Santa Rosa, California, United States
- Stanford University Medical Center — Stanford, California, United States
- University Of Colorado Denver — Aurora, Colorado, United States
- IMMUNOe International Research Centers — Thornton, Colorado, United States
- Associated Neurologists of Southern Connecticut, PC — Fairfield, Connecticut, United States
- Yale University School Of Medicine — New Haven, Connecticut, United States
- Research Center for Clinical Studies, Inc. — Norwalk, Connecticut, United States
- JEM Research Institute — Atlantis, Florida, United States
- Bradenton Research Center, Inc. — Bradenton, Florida, United States
- Meridien Research — Brooksville, Florida, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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