KarXT + KarX-EC for Alzheimer's Disease
(MINDSET 1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment combination, KarXT and KarX-EC, to determine its effectiveness in addressing memory and thinking problems in individuals with Alzheimer's disease. Researchers aim to assess the safety and efficacy of this treatment for those in mild to moderate stages of the disease. Participants must have a doctor's confirmation of Alzheimer's and exhibit noticeable memory or thinking issues. A caregiver is essential to assist participants throughout the study. As a Phase 3 trial, this represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.
Do I have to stop taking my current medications for the trial?
If you are taking acetyl choline esterase inhibitors (AChEIs) or memantine, you must have been on a stable dose for at least 12 weeks before the trial and continue that dose during the study. The protocol does not specify about other medications, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of KarXT and KarX-EC has been tested for safety in people with Alzheimer's Disease, particularly those experiencing agitation and psychosis. A study on long-term use found that this treatment was generally well-tolerated, with most side effects being mild to moderate.
Previous participants commonly reported side effects such as dry mouth and constipation, which can be managed. Importantly, no serious side effects have been directly linked to the treatment in these studies.
Since this trial is in a late phase, earlier tests have demonstrated the treatment's reasonable safety. For those considering joining a trial, it is reassuring that these studies have consistently shown it to be safe.12345Why are researchers excited about this trial's treatments?
Researchers are excited about KarXT + KarX-EC for Alzheimer's disease because it offers a novel approach compared to current treatments. Unlike standard therapies, which often target amyloid plaques or tau tangles, these treatments work by modulating the muscarinic and nicotinic acetylcholine receptors, potentially improving communication between brain cells. This unique mechanism could lead to better cognitive function and fewer side effects. Additionally, the combination of KarXT and KarX-EC may enhance the overall effectiveness, offering hope for a more robust treatment option.
What evidence suggests that this trial's treatments could be effective for cognitive impairment in Alzheimer's Disease?
Research has shown that the combination of KarXT and KarX-EC, which participants in this trial may receive, may help treat symptoms of Alzheimer's Disease, particularly issues with thinking and memory. Studies have found that this treatment can also manage restlessness and hallucinations, common in Alzheimer's patients. It affects specific brain areas that control memory and behavior. Previous patients demonstrated improvement in their symptoms with KarXT + KarX-EC, suggesting its potential effectiveness for cognitive issues in Alzheimer's Disease.23678
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 Alzheimer's Disease or Mild Cognitive Impairment. Specific eligibility criteria are not provided, but typically participants should be in stable health and meet certain cognitive thresholds.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KarXT + KarX-EC or placebo to evaluate efficacy and safety for cognitive impairment in Alzheimer's Disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KarX-EC
- KarXT
- Placebo
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