Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease
Study Phase: Phase 2
Recruitment Status: Recruiting
Start Date: March 20, 2024
End Date: November 16, 2027
BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
855-907-3286
First line of the email MUST contain NCT # and Site #.
- 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.
-
Conditions:
- Alzheimer Disease