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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06268886

Acronym

TargetTau-1

Enrollment

310

Registered

2024-02-20

Start date

2024-03-20

Completion date

2027-03-18

Last updated

2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Early Onset

Keywords

Alzheimer Disease, BMS-986446, Neurodegenerative disease, Dementia, Brain Diseases, Anti-MTBR tau monoclonal antibody, TargetTau-1, Anti-tau therapy

Brief 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.

Interventions

DRUGBMS-986446

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score	At week 76
Change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) score	At week 76
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) score	At week 76
Change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score	At week 76
Change from baseline in Mini Mental State Examination (MMSE) score	At week 76

Countries

Australia, Belgium, Canada, Japan, Singapore, South Korea, Spain, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026