KarXT + KarX-EC for Alzheimer's Disease

(MINDSET 2 Trial)

Recruiting at 162 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 the effectiveness and safety of two treatments, KarXT and KarX-EC, for individuals with mild to moderate Alzheimer's disease, which affects memory and thinking. Participants will receive either the active treatments or a placebo (a dummy treatment) to compare results. The trial seeks individuals with Alzheimer's who have a caregiver available to assist them and who have been on certain stable medications for at least 12 weeks. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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 shows that KarXT + KarX-EC is being tested for safety in treating Alzheimer's Disease. In earlier studies, participants used KarXT + KarX-EC for issues like agitation and psychosis related to Alzheimer's. These studies aimed to assess how well people tolerated the treatment over time.

The results suggest that KarXT + KarX-EC is generally well-tolerated. Some participants experienced side effects, mostly mild to moderate, such as dry mouth and constipation. These side effects are common with similar medications and are usually not severe.

Since the current trial is in a later stage, the treatment has already demonstrated a reasonable level of safety in earlier studies. This is a positive sign for those considering joining the trial. ^{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 these treatments target the condition in a novel way. Unlike existing treatments, which often focus on neurotransmitters like acetylcholine or glutamate, KarXT + KarX-EC work by modulating muscarinic receptors, potentially offering a new pathway to manage symptoms. This mechanism could result in fewer side effects and improved cognitive outcomes, making it a promising option beyond standard treatments like cholinesterase inhibitors and NMDA receptor antagonists. The innovative approach of combining KarXT with KarX-EC may enhance the effectiveness and tolerability of the treatment, offering hope for better management of Alzheimer's symptoms.

What evidence suggests that this trial's treatments could be effective for cognitive impairment in Alzheimer's Disease?

This trial will compare the combination of KarXT and KarX-EC with a placebo to evaluate their effectiveness in treating Alzheimer's Disease. Research has shown that this combination might help with memory and thinking problems in Alzheimer's Disease. Previous studies found that it can also reduce symptoms like confusion and restlessness related to Alzheimer's. These results suggest that KarXT and KarX-EC may improve brain function and behavior. Additionally, research on long-term use has shown positive outcomes, supporting its potential in managing Alzheimer's symptoms. Overall, early evidence is promising for those facing cognitive challenges due to 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 details about who can join are not provided, but typically participants must meet certain health criteria and may need to have a specific level of cognitive function.

Inclusion Criteria

Participants must have an MMSE score ranging from 12 through 22 at the time of screening

Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits

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

I do not have any severe health issues that could affect my safety or participation in the study.

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 impact 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 treatments: 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.