KarXT + KarX-EC for Alzheimer's Disease

(MINDSET 1 Trial)

Recruiting at 112 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

Trial Summary

What is the purpose of this trial?

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

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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