Phase 2 Infusion Study of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody

  • Study Director: Peter Ljubenkov, MD
  • Sponsor: Bristol-Myers Squibb
  • Status: Recruiting (screening closes March 28, 2025)
  • Official Study Title: A Randomized, Double-blind, Placebo-controlled, Global, 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)
  • ClinicalTrials.gov Identifier: NCT06268886
  • Conditions Studied: Mild cognitive impairment (MCI), Alzheimer's disease (AD)
  • Intervention: BMS-986446
  • Phase: Phase 2
  • Duration of Participation: Up to 2 years including the screening period

Purpose of the Study

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.

Eligibility

What to Expect

Testing: Neurological and physical examinations, cognitive testing and neuropsychiatric assessments, telephone calls, blood and urine specimen collection, vital signs, and a PET scan

The Frequency of Visits: Visits occur every 4 weeks

Materials Needed Before Evaluation: Prior to participating in the trial, the patient will need a diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria.

Costs: No costs will be charged for any of the study procedures. Parking will be reimbursed.

Contact Information

Coordinator: [email protected]
Clinical Trials Nurse: Whitney Walker, MS, CNS, RN – [email protected], 415.353.7532