What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and memantine. Cholinesterase inhibitors can cause side effects such as nausea, vomiting, diarrhea, muscle cramps, and fatigue. Memantine may cause dizziness, headache, confusion, and constipation. For treatments similar to Anti-MTBR Tau Monoclonal Antibodies, such as semorinemab, side effects observed in trials include similar proportions of adverse events compared to placebo, indicating an acceptable and well-tolerated safety profile. However, specific side effects for Anti-MTBR Tau Monoclonal Antibodies are still under investigation.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and NMDA receptor antagonists (memantine). These drugs aim to improve cognitive function and manage symptoms but do not alter the disease's progression. As of now, there are no FDA-approved treatments specifically targeting tau proteins, such as Anti-MTBR Tau Monoclonal Antibodies like BMS-986446. Current research and clinical trials are exploring these novel therapeutic approaches to address the underlying pathology of Alzheimer's Disease.

What other types of research exist?

Promising alternatives to BMS-986446 for Alzheimer's Disease include: 1) Aducanumab, an IgG1 anti-Aβ antibody approved in 2021 targeting amyloid plaques. 2) Lecanemab, another anti-Aβ antibody showing potential in clinical trials. 3) Donanemab, targeting amyloid plaques and showing promise in early studies. These treatments focus on amyloid-beta plaques, a key pathological feature of Alzheimer's Disease.

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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 below

Select...

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

This trial's timeline: 8 weeks for screening, 18 months for treatment, and 9 weeks for reporting.

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

0 / 1Eligibility criteria met

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.