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

NCT06268886 · tracked via the Priya Life Science Australia tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 2

Started

2024-03-20

Last updated

2025-07-24

Condition(s) studied

Alzheimer Disease, Early Onset

Investigational drug(s) / intervention(s)

BMS-986446 →Placebo

BMS-986446: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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

Sex

ALL

Min age

50 Years

Max age

80 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) — At week 76

Trial sites (176)

Facility	City	Region
Local Institution - 0068	Chandler	Arizona
Local Institution - 0102	Gilbert	Arizona
Local Institution - 0019	Phoenix	Arizona
Local Institution - 0018	Scottsdale	Arizona
Local Institution - 0026	Scottsdale	Arizona
Local Institution - 0077	Tucson	Arizona
Local Institution - 0038	Tucson	Arizona
Local Institution - 0164	Encino	California
Local Institution - 0139	Fullerton	California
Local Institution - 0191	Irvine	California
Local Institution - 0234	Long Beach	California
Local Institution - 0142	Los Alamitos	California
Local Institution - 0037	Napa	California
Local Institution - 0209	Sacramento	California
Local Institution - 0052	San Francisco	California
Local Institution - 0137	Santa Ana	California
Local Institution - 0046	Sherman Oaks	California
Local Institution - 0106	Danbury	Connecticut
Local Institution - 0148	New Haven	Connecticut
Local Institution - 0056	New Haven	Connecticut
Local Institution - 0153	Stamford	Connecticut
Local Institution - 0022	Altamonte Springs	Florida
Local Institution - 0048	Atlantis	Florida
Local Institution - 0228	Boca Raton	Florida
Local Institution - 0250	Boca Raton	Florida
Local Institution - 0224	Bradenton	Florida
Local Institution - 0020	Clermont	Florida
Local Institution - 0009	Daytona Beach	Florida
Local Institution - 0213	Fort Myers	Florida
Local Institution - 0059	Greenacres City	Florida
Local Institution - 0207	Hialeah	Florida
Local Institution - 0212	Hialeah	Florida
Local Institution - 0198	Hialeah	Florida
Local Institution - 0151	Lady Lake	Florida
Local Institution - 0146	Lakeland	Florida
Local Institution - 0192	Maitland	Florida
Local Institution - 0143	Maitland	Florida
Local Institution - 0027	Merritt Island	Florida
Local Institution - 0203	Miami	Florida
Local Institution - 0058	Miami	Florida

+ 136 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06268886 on ClinicalTrials.gov ↗ ← All trials in Australia