Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease (TargetTau-1)

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer Disease, Early Onset

Treatments: Other: Placebo; Drug: BMS-986446

Study type: Interventional

Funder types: Industry

Identifiers

NCT06268886

CN008-0003

2023-504840-32-00 (Registry Identifier)

U1111-1290-3539 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 475 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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475 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

BMS-986446 Dose A

Experimental group

Treatment:

Drug: BMS-986446

BMS-986446 Dose B

Experimental group

Treatment:

Drug: BMS-986446

Sponsor of this trial

Lead Sponsor

Bristol-Myers Squibb (BMS)