Not currently recruiting at UCSF

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 study on Alzheimer's Disease

Summary

Eligibility
for people ages 50-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

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.

Official Title

A Randomized, Double-blind, Placebo-controlled, Global, 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)

Keywords

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

Eligibility

You can join if…

Open to people ages 50-80

  • 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).

You CAN'T join if...

  • 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.

Locations

  • UCSF Medical Center- Mission Bay not yet accepting patients
    San Francisco California 94143-2350 United States
  • Neurovations not yet accepting patients
    Napa California 94558-2415 United States
  • California Neuroscience Research Medical Group, Inc (CNR) accepting new patients
    Sherman Oaks California 91403-2131 United States
  • Perseverance Research Center (PRC) accepting new patients
    Scottsdale Arizona 85253 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06268886
Phase
Phase 2 Alzheimer's Disease Research Study
Study Type
Interventional
Participants
Expecting 475 study participants
Last Updated