TargetTau-1

Active not recruitingPhase 2

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

A Randomized, Double-blind, Placebo-controlled, Global Proof-of-concept Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Participants With Early Alzheimer's Disease (TargetTau-1)

Lead sponsor

Bristol-Myers Squibb

Asset

BMS-986446

Listed sites

176

Recruiting sites

Enrollment

310

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•mild AD dementia•CDR global 0.5-1•MMSE 20-28

Primary endpoint

•Brain tau deposition

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Secondary ID2023-504840-32EU CTR

Org study IDCN008-0003

NCT IDNCT06268886

RegistryU1111-1290-3539WHO

Timeline

Milestones

Study first posted2024-02-20actual

Study start2024-03-20actual

Last update posted2025-07-24actual

Primary completion2027-03-18estimated

Study completion2027-03-18estimated

Assets

Drug assets

BMS-986446

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Global cognition

Function / daily living

Global cognition

2 endpoints

Secondary/protocol endpoint

Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score

Time frame:At week 76

Clinical Dementia Rating-Sum of Boxes (CDR-SB)