BMS-986446 for Early Alzheimer's Disease
(TargetTau-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the drug BMS-986446 (an anti-tau antibody) to determine its safety, tolerability, and effectiveness for individuals with early Alzheimer's disease. Alzheimer's can lead to memory problems and thinking difficulties, and this trial aims to discover if the new treatment can help. Participants will receive either one of two doses of the drug or a placebo (a substance with no active medication) for comparison. It suits those with mild memory issues due to Alzheimer's, as confirmed by a doctor, and who do not have other conditions affecting memory. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that BMS-986446 is likely to be safe for humans?
Research has shown that BMS-986446, a monoclonal antibody treatment, is being tested for safety in people. Early studies indicate that participants have generally tolerated the treatment well, with no major safety issues reported. The treatment has progressed to Phase 2 testing, meaning earlier studies did not find serious safety problems, allowing more participants. While this doesn't guarantee complete safety, it is a positive sign for those considering joining the trial. Participants might experience some side effects, but researchers are carefully monitoring these as the study continues.12345
Why do researchers think this study treatment might be promising for Alzheimer's?
Unlike current treatments for Alzheimer's, which primarily focus on managing symptoms with medications like donepezil or memantine, BMS-986446 offers a fresh approach by targeting the underlying disease process. Researchers are excited about BMS-986446 because it represents a novel strategy, potentially modifying the disease progression itself. This treatment could provide a new hope for slowing down or even halting the advancement of early Alzheimer's, which is a significant step forward compared to existing symptom-focused therapies.
What evidence suggests that BMS-986446 might be an effective treatment for early Alzheimer's disease?
Research shows that BMS-986446, which participants in this trial may receive, targets a protein called tau, believed to play a key role in Alzheimer's disease. This treatment is a monoclonal antibody, a lab-made protein that functions like an antibody to combat harmful proteins. Early findings suggest that targeting tau might help slow or stop Alzheimer's by preventing the spread of toxic tau proteins in the brain. Although detailed human data is still being gathered, targeting tau appears promising based on current scientific understanding of Alzheimer's. As more information becomes available, researchers will better understand the potential effectiveness of BMS-986446.12346
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BMS-986446 or placebo to evaluate efficacy, safety, and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986446
Trial Overview
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Published Research Related to This Trial
Citations
Prothena's Partner Bristol Myers Squibb Obtains Fast Track ...
BMS-986446 is a humanized monoclonal antibody that targets multiple domains of the microtubule binding region of tau, a highly pathogenic tau ...
NCT06268886 | Study to Evaluate the Efficacy, Safety, and ...
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 ...
study connect - BMS Clinical Trials
The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in ...
Prothena Reports Topline Phase 1 Single Ascending Dose ...
These results support the ongoing Phase 1 MAD trial of PRX005 in patients with Alzheimer's disease. Topline results from the Phase 1 MAD trial ...
TargetTau‐1: Design of a phase 2 trial to evaluate ...
The phase 2 TargetTau‐1 trial will assess efficacy, safety, and tolerability of BMS‐986446, an anti‐MTBR tau monoclonal antibody, in patients with early AD.
Anti-tau antibody therapy (BMS-986446) for early Alzheimer's ...
This phase 2 study will evaluate the safety, tolerability, and efficacy of BMS-986446 in participants ages 50-80 years with early Alzheimer's disease for 76 ...
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