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221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
PLS AVAILABLE
Study Identifier221AD301
Clinicaltrials.gov
#NCT02477800
Details
Development Status
Withdrawn
Study Type
Interventional
Results Available
Yes
Study Dates
08/2015 - 08/2019
Enrollment
1653
Commercial Product
ADUHELM®
Study Drug
Placebo, BIIB037 (aducanumab)
Summary
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].
Study Results
View and download the Results Summaries with the results of this completed study.
PDF
CSR Synopsis
PDF Document
PDF
Plain Language Summary
PDF Document
View study results on registries