NCT05310071

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease

A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,027 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer's disease.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Aducanumab	Administered as specified in the treatment arm.
DRUG	Placebo	Administered as specified in the treatment arm.

Timeline

• Start date: 2022-06-02
• Primary completion: 2024-08-12
• Completion: 2024-08-12
• First posted: 2022-04-04
• Last updated: 2025-04-23
• Results posted: 2025-04-23

Locations

265 sites across 16 countries: United States, Australia, Belgium, Brazil, Canada, Finland, France, Germany, Italy, Japan, Mexico, Poland, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study