BMS-986446 for Early Alzheimer's Disease

(TargetTau-1 Trial)

Not currently recruiting at 391 trial locations
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Overseen ByJeffrey Ross, Site 0021
Age: 18+
Sex: Any
Travel: May Be Covered
Trial Phase: Phase 2
Sponsor: Bristol-Myers Squibb
Prior Safety DataThis treatment has passed at least one previous human 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?

BS

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

I have mild memory problems or mild Alzheimer's according to NIA-AA standards.
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)
Have you had difficulty managing complex tasks like paying bills or following medication schedules?
See 9 more

Exclusion Criteria

I have a condition affecting my thinking or memory that is not Alzheimer's.
Contraindications to PET imaging
Inability to tolerate or contraindication to magnetic resonance imaging
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BMS-986446 or placebo to evaluate efficacy, safety, and tolerability

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

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

Group I: BMS-986446 Dose BExperimental Treatment1 Intervention
Group II: BMS-986446 Dose AExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials
2,731
Recruited
4,127,000+
Headquarters
New York City, USA
Known For
Oncology & Cardiovascular
Top Products
Eliquis, Opdivo, Revlimid, Orencia
Christopher Boerner profile image

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 profile image

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

Zagotenemab, a monoclonal antibody targeting misfolded tau proteins, was found to be safe in a Phase Ib study with 22 participants aged 59 to 84, showing no deaths and only a few serious adverse events, which led to discontinuation in two cases.
The pharmacokinetics of zagotenemab were consistent with typical monoclonal antibodies, with a half-life of about 20 days and a dose-dependent increase in plasma tau, although no significant pharmacodynamic effects were observed due to the low dose levels and short treatment duration.
Safety, Tolerability, and Pharmacokinetics of Zagotenemab in Participants with Symptomatic Alzheimer's Disease: A Phase I Clinical Trial.Willis, BA., Lo, AC., Dage, JL., et al.[2023]
Intracellular targeting of tau using specific intrabodies (iBs) was found to be more effective in reducing tau pathology and delaying paralysis in tauopathy models compared to extracellular targeting with single-chain variable fragments (scFvs).
The study indicates that disease-modifying effects can occur without the need for traditional antibody functions, highlighting the potential of using phosphorylated tau-specific iBs for therapeutic strategies in neurodegenerative tauopathies.
Anti-tau scFvs Targeted to the Cytoplasm or Secretory Pathway Variably Modify Pathology and Neurodegenerative Phenotypes.Goodwin, MS., Sinyavskaya, O., Burg, F., et al.[2022]
The antibody variant dmCBTAU-22.1, derived from healthy human donors, shows improved affinity and potency in inhibiting the spreading of tau aggregates associated with Alzheimer's disease, suggesting it could be an effective immunotherapy.
In addition to inhibiting tau aggregation, dmCBTAU-22.1 may also interfere with the initial nucleation of tau, which is a critical early step in the development of tau-related neurological disorders, as demonstrated in a transgenic mouse model.
Enhancement of therapeutic potential of a naturally occurring human antibody targeting a phosphorylated Ser422 containing epitope on pathological tau.van Ameijde, J., Crespo, R., Janson, R., et al.[2019]

Citations

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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 ...