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Evaluating a new antibody treatment for 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)

Phase 2 Interventional Bristol-Myers Squibb · NCT06268886

This study is testing a new antibody treatment for people with early Alzheimer's disease to see if it can help improve their thinking and memory skills.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment310 (estimated)
Ages50 Years to 80 Years
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations204 sites (Chandler, Arizona and 203 other locations)
Trial IDNCT06268886 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy, safety, and tolerability of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in participants diagnosed with early Alzheimer's disease. Participants will receive either the treatment or a placebo to determine its effectiveness in improving cognitive function. The study focuses on individuals with mild cognitive impairment or mild dementia due to Alzheimer's, using specific clinical criteria for eligibility. Assessments will include cognitive tests and imaging to monitor the treatment's impact on Alzheimer's pathology.

Who should consider this trial

Good fit: Ideal candidates are individuals with mild cognitive impairment or mild dementia due to Alzheimer's disease, meeting specific clinical criteria.

Not a fit: Patients with cognitive impairment due to conditions other than Alzheimer's disease or those unable to undergo necessary imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with early Alzheimer's disease, potentially slowing disease progression.

How similar studies have performed: Other studies targeting tau pathology in Alzheimer's disease have shown promise, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Chandler, Arizona and 203 other locations

+154 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Alzheimer Disease, Early OnsetAlzheimer DiseaseBMS-986446Neurodegenerative diseaseDementiaBrain DiseasesAnti-MTBR tau monoclonal antibodyTargetTau-1
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.