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Therapeutic Areas: Neurology | Family Medicine
Disease Category: Alzheimer's Disease
Location: United States, FL
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Aducanumab (BIIB037) in Subjects With Early Alzheimer's Disease
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].
CW ID: 209892
Date Last Changed:
August 18, 2015
Key Inclusion Criteria:
Must meet all of the following clinical criteria for MCI due to AD or mild AD and must have:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Protocol Number: 221AD301
Jill SmithUniversity of South Florida- Byrd Alzheimer's Institute4001 East Fletcher AvenueTampa, FL 33613Phone: 813-974-1294
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