NCT06268886 · Phase 2 · ACTIVE NOT RECRUITING
Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
This Phase 2 trial is testing BMS-986446, an antibody designed to target a specific form of tau protein that builds up in Alzheimer's disease. Researchers want to know whether it slows cognitive decline, and whether it is safe and tolerable. Phase 2 means this is a mid-stage test — researchers are looking for signs it works and checking for side effects, but it is not yet proven or approved.
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're excluded 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-07-24