KarXT + KarX-EC for Alzheimer's Disease

Recruiting at 162 trial locations

Overseen By BMS Study Connect Contact Center, www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Disqualifiers: Cardiovascular, Pulmonary, Renal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 26-30 weeks

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for people who have Alzheimer's Disease with symptoms of agitation and completed previous studies CN012-0023 or CN012-0024. They must also have a caregiver available for at least 10 hours per week.

Inclusion Criteria

I completed study CN012-0023 or CN012-0024 as required.

I have a caregiver who can be with me for 10 or more hours a week.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive KarXT + KarX-EC for the treatment of agitation associated with Alzheimer's Disease

26-30 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants continue to receive KarXT + KarX-EC to evaluate long-term safety and tolerability

Long-term

Treatment Details

Interventions

• KarXT + KarX-EC

Trial Overview The study tests the long-term effects and safety of KarXT (a combination of xanomeline tartrate/trospium chloride) and KarX-EC, both aimed at reducing agitation in Alzheimer's patients.

Participant Groups

Group I: KarXT+KarX-EC Experimental Treatment 2 Interventions

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