- Study Director: Peter Ljubenkov, MD
- Sponsor: Bristol-Myers Squibb
- Status: Active trial, closed to new enrollment
- 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
Inclusion Criteria
- 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.
- Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline.
- Evidence of AD pathology.
- Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II).
- Mini Mental Status Examination (MMSE) score ≥22 to 30 (inclusive).
Exclusion Criteria
- Any evidence of a condition that may affect cognition other than AD.
- Contraindications to PET imaging.
- Inability to tolerate or contraindication to magnetic resonance imaging.
- Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments.
- Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening.
- Other protocol-defined Inclusion/Exclusion criteria apply.
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