221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease
Status:
Terminated
Trial end date:
2019-08-08
Target enrollment:
Participant gender:
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].