NCT04241068

A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,696 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).

Conditions

• Alzheimer's Disease

Interventions

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

Timeline

• Start date: 2020-03-02
• Primary completion: 2024-07-22
• Completion: 2024-07-22
• First posted: 2020-01-27
• Last updated: 2025-02-21
• Results posted: 2025-02-21

Locations

297 sites across 20 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Poland, Portugal, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study