NCT02477800

221AD301 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer's Disease

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,653 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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) \[ADCS-ADL-MCI\].

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Aducanumab (BIIB037)	Low dose
DRUG	Aducanumab (BIIB037)	High dose
DRUG	Placebo	Placebo

Timeline

• Start date: 2015-08-13
• Primary completion: 2019-08-08
• Completion: 2019-08-08
• First posted: 2015-06-23
• Last updated: 2021-09-02
• Results posted: 2021-09-02

Locations

181 sites across 14 countries: United States, Australia, Austria, Canada, Denmark, France, Germany, Italy, Japan, Portugal, South Korea, Spain, Taiwan, United Kingdom