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 UC Davis UCSF
Dates
study started
study ends 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 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)

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 ≥ 20 to 28 (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

  • University of California Davis (UC Davis) - Alzheimer's Disease Center (ADC) - Sacramento accepting new patients
    Sacramento California 95816 United States
  • UCSF Medical Center at Mission Bay accepting new patients
    San Francisco California 94143-2350 United States
  • Irvine Center for Clinical Research accepting new patients
    Irvine California 92614-9403 United States
  • California Neuroscience Research Medical Group, Inc (CNR) accepting new patients
    Sherman Oaks California 91403-2131 United States
  • Pharmacology Research Institute (PRI) - Encino accepting new patients
    Encino California 91316-1511 United States
  • Local Institution - 0183 not yet accepting patients
    Santa Ana California 92701-4607 United States
  • Syrentis Clinical Research accepting new patients
    Santa Ana California 92705-8675 United States
  • Local Institution - 0142 completed
    Los Alamitos California 90720-3589 United States
  • Neurology Center of North Orange County accepting new patients
    Fullerton California 92835-1040 United States
  • Local Institution - 0073 withdrawn
    Lomita California 90717-2101 United States

Details

Status
accepting new patients
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 310 study participants
Last Updated