NCT03352557

Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 654 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD. The primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	BIIB092	Administered as specified in treatment arm.
DRUG	Placebo	Administered as specified in treatment arm.

Timeline

• Start date: 2018-05-03
• Primary completion: 2021-08-30
• Completion: 2021-08-30
• First posted: 2017-11-24
• Last updated: 2022-11-08
• Results posted: 2022-11-08

Locations

101 sites across 9 countries: United States, Australia, France, Germany, Italy, Japan, Poland, Spain, Sweden

Regulatory

• FDA-regulated drug study