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) logo

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

50 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 ≥ 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

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

Trial contacts and locations

184

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Central trial contact

First line of the email MUST contain NCT # and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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