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Active Not Recruiting NCT06268886

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

Conditions: Alzheimer Disease, Early Onset

Sex: All
Ages: 50 Years – 80 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 310
Sponsor: Bristol-Myers Squibb

Location: Local Institution - 0068 Chandler Arizona

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 Criteria

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 ≥ 20 to 28 (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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06268886). StuddyBuddy aggregates publicly available trial information.