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

ID#: NCT06268886

Age: 50 - 80 years

Gender: All

Healthy Subjects: No

Study Phase: Phase 2

Recruitment Status: Recruiting

Start Date: March 20, 2024

End Date: November 16, 2027

Contact Information:
BMS Study Connect Contact Center
First line of the email MUST contain NCT # and Site #.
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.
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.