KarXT + KarX-EC for Alzheimer's Disease

(MINDSET 1 Trial)

Recruiting at 160 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must be taking: Acetyl choline esterase inhibitors, Memantine

Must not be taking: Anti-amyloid therapies

Disqualifiers: Hepatic impairment, Major depression, Schizophrenia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

586 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 3 6 7 8}

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

My Alzheimer's diagnosis follows the latest NIA-AA guidelines.

I have a caregiver who can attend all study visits with me.

Caregiver must be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in study-related activities

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion

My brain MRI does not show any major issues that could affect my safety in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KarXT + KarX-EC or placebo to evaluate efficacy and safety for cognitive impairment in Alzheimer's Disease

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• KarX-EC
• KarXT
• Placebo

Trial Overview The study is testing the effectiveness and safety of two interventions: KarXT and KarX-EC, compared to a placebo. The goal is to see if these treatments improve cognitive impairment in Alzheimer's patients.

How Is the Trial Designed?

Group I: KarXT + KarX-EC Active Control 2 Interventions

Group II: Placebo Placebo Group 1 Intervention

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

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06947941

A Study to Evaluate Safety and Efficacy of KarXT + KarX ... The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease. Official Title. A Phase 3, Randomized ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-long-term-efficacy-and-safety-of-karxt-karx-ec-for-agitation-in-alzheimer

A Study to Evaluate the Long-term Efficacy and Safety of ... The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07011745

NCT07011745 | A Phase 3 Study to Evaluate the Safety ... The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

4. bmsstudyconnect.com bmsstudyconnect.com/pl/en/clinical-trials/NCT06976216.html

A Study to Evaluate the Efficacy and Safety of KarXT + KarX ... The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease.

5. patlynk.com patlynk.com/trial/NCT07011732

KarXT + KarX-EC for Agitation in Alzheimer's Disease This clinical trial aims to test a new treatment combination, KarXT + KarX-EC, for adults experiencing agitation due to Alzheimer's Disease.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07011745

NCT07011745 | A Phase 3 Study to Evaluate the Safety ... The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

7. clinicaltrials.eu clinicaltrials.eu/trial/study-of-trospium-chloride-and-xanomeline-tartrate-combination-for-agitation-in-alzheimers-disease-patients-long-term-safety-evaluation/

Study of trospium chloride and xanomeline tartrate ... This study focuses on testing medications called KarXT and KarX-EC in people who have Alzheimer's Disease with agitation.

8. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT06937229

Trial ID CN012-0025 | NCT06937229 - BMS Clinical Trials The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride.