221AD301 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
- NCT02477800
- Run by
- Biogen
- People needed
- 1653
- Starts
- 2015-08-13
- Expected to finish
- 2019-08-08
- 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
- Center for Neurosciences — Tucson, Arizona, United States
- Neurology Center of North Orange County — Fullerton, California, United States
- Senior Clinical Trials, Inc. — Laguna Hills, California, United States
- Torrance Clinical Research Institute, Inc. — Lomita, California, United States
- University of California - Los Angeles — Los Angeles, California, United States
- UCSF - Memory and Aging Center — San Francisco, California, United States
- California Neuroscience Research Medical Group Inc. — Sherman Oaks, California, United States
- Southern California Research LLC — Simi Valley, California, United States
- Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
- Georgetown University Hospital — Washington D.C., District of Columbia, United States
- Brain Matters Research, Inc. — Delray Beach, Florida, United States
- Neuropsychiatric Research Center of Southwest Florida — Fort Myers, Florida, United States
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
- University of Miami — Miami, Florida, United States
- Miami Jewish Health Systems — Miami, Florida, United States
- Compass Research Main — Orlando, Florida, United States
- Palm Beach Neurological Center — Palm Beach Gardens, Florida, United States
- Stedman Clinical Trials, LLC — Tampa, Florida, United States
- USF Health Byrd Institute — Tampa, Florida, United States
- Meridien Research — Tampa, Florida, United States
- Compass Research Main — The Villages, Florida, United States
- Premiere Research Institute — West Palm Beach, Florida, United States
- Cleveland Clinic Florida - Weston — Weston, Florida, United States
- Alexian Brothers Neurosciences Institute — Elk Grove Village, Illinois, United States
- St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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