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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Alzheimer Disease, Early Onset

In brief

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.

Key facts

Study ID

NCT06268886

Run by

Bristol-Myers Squibb

People needed

310

Starts

2024-03-20

Expected to finish

2027-03-18

Last updated by the study team

2025-07-24

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ≥ 20 to 28 (inclusive).

You may not qualify if…

• 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.

Where it is running

• Local Institution - 0102 — Gilbert, Arizona, United States
• Local Institution - 0019 — Phoenix, Arizona, United States
• Local Institution - 0018 — Scottsdale, Arizona, United States
• Local Institution - 0026 — Scottsdale, Arizona, United States
• Local Institution - 0077 — Tucson, Arizona, United States
• Local Institution - 0038 — Tucson, Arizona, United States
• Local Institution - 0164 — Encino, California, United States
• Local Institution - 0139 — Fullerton, California, United States
• Local Institution - 0191 — Irvine, California, United States
• Local Institution - 0234 — Long Beach, California, United States
• Local Institution - 0142 — Los Alamitos, California, United States
• Local Institution - 0037 — Napa, California, United States
• Local Institution - 0209 — Sacramento, California, United States
• Local Institution - 0052 — San Francisco, California, United States
• Local Institution - 0137 — Santa Ana, California, United States
• Local Institution - 0046 — Sherman Oaks, California, United States
• Local Institution - 0106 — Danbury, Connecticut, United States
• Local Institution - 0148 — New Haven, Connecticut, United States
• Local Institution - 0056 — New Haven, Connecticut, United States
• Local Institution - 0153 — Stamford, Connecticut, United States
• Local Institution - 0022 — Altamonte Springs, Florida, United States
• Local Institution - 0048 — Atlantis, Florida, United States
• Local Institution - 0228 — Boca Raton, Florida, United States
• Local Institution - 0250 — Boca Raton, Florida, United States
• Local Institution - 0068 — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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