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Monoclonal Antibodies
BMS-986446 for Early Alzheimer's Disease (TargetTau-1 Trial)
Phase 2
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Be older than 18 years old
Timeline
Screening 8 weeks
Treatment 18 months
Follow Up 9 weeks
Summary
This trial is testing a new medication called BMS-986446 in people with early Alzheimer's disease. The medication is designed to target harmful proteins in the brain to slow down the disease. Researchers are checking if it works well and is safe for patients.
Who is the study for?
This trial is for individuals with early Alzheimer's Disease. Specific criteria for joining are not provided, but typically participants must meet certain health standards and may need to have a particular stage or form of the condition.
What is being tested?
The study is testing BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, against a placebo to see if it's effective and safe in treating early Alzheimer's Disease.
What are the potential side effects?
While specific side effects are not listed, monoclonal antibodies like BMS-986446 can sometimes cause reactions at the injection site, flu-like symptoms, allergic reactions, or other immune system-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild memory problems or mild Alzheimer's according to NIA-AA standards.
Timeline
Screening ~ 8 weeks4 visits
Treatment ~ 18 months21 visits
Follow Up ~ 9 weeks1 visit
Screening ~ 8 weeks
Treatment ~ 18 months
Follow Up ~9 weeks
Treatment Details
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: BMS-986446 Dose BExperimental Treatment1 Intervention
Group II: BMS-986446 Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BMS-986446
2023
Completed Phase 1
~30
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease (AD) primarily include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine in the brain, which helps improve cognitive function and slow symptom progression.
Memantine helps regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Emerging treatments like BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, target tau protein aggregation, a hallmark of AD pathology, aiming to prevent or reduce neurofibrillary tangles.
These mechanisms are crucial as they address different aspects of AD pathology, potentially offering more comprehensive management of the disease.
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Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,690 Previous Clinical Trials
4,097,065 Total Patients Enrolled
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