NCT06268886

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

A Randomized, Double-blind, Placebo-controlled, Global Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease (TargetTau-1)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.

Conditions

• Alzheimer Disease, Early Onset

Interventions

Type	Name	Description
DRUG	BMS-986446	Specified dose on specified days
OTHER	Placebo	Specified dose on specified days

Timeline

• Start date: 2024-03-20
• Primary completion: 2027-03-18
• Completion: 2027-03-18
• First posted: 2024-02-20
• Last updated: 2025-07-24

Locations

176 sites across 10 countries: United States, Australia, Belgium, Canada, Japan, Singapore, South Korea, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study