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325 Participants NeededMy employer runs this trial

KarXT + KarX-EC for Alzheimer's Disease

Recruiting at 18 trial locations
BS
BC
Overseen ByBMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Bristol-Myers Squibb
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate KarXT + KarX-EC as a treatment for psychosis associated with Alzheimer's disease.

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 55 and 90 years old.
Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation)
I have been diagnosed with Alzheimer's disease using the 2024 revised criteria.
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Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply
My psychotic symptoms are only due to my Alzheimer's disease.
Participants must not have certain safety concerns, including certain laboratory test irregularities
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What Are the Treatments Tested in This Trial?

Interventions

  • KarXT + KarX-EC

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: KarXT + KarX-EC ArmExperimental Treatment2 Interventions
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

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