This study is in progress, not accepting new patients

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 Neurodegenerative Disease Dementia

Summary

Eligibility
for people ages 50-80 (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Peter Ljubenkov (ucsf)

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, Neurodegenerative Diseases

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

  • Local Institution - 0052
    San Francisco California 94143-2350 United States
  • Local Institution - 0191
    Irvine California 92614-9403 United States
  • Local Institution - 0046
    Sherman Oaks California 91403-2131 United States
  • Local Institution - 0164
    Encino California 91316-1511 United States
  • Local Institution - 0137
    Santa Ana California 92705-8675 United States
  • Local Institution - 0142
    Los Alamitos California 90720-3589 United States
  • Local Institution - 0209
    Sacramento California 95816 United States
  • Local Institution - 0139
    Fullerton California 92835-1040 United States
  • Local Institution - 0234
    Long Beach California 90804-2128 United States
  • Local Institution - 0037
    Napa California 94558-2415 United States

Lead Scientist at University of California Health

  • Peter Ljubenkov (ucsf)
    Dr. Peter A. Ljubenkov is a behavioral neurologist who specializes in caring for patients experiencing memory, language and behavioral changes due to neurological conditions, such as Alzheimer's disease, Lewy body dementia and other causes of dementia.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
ID
NCT06268886
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 310 study participants
Last Updated