325 Participants NeededMy employer runs this trial

KarXT + KarX-EC for Alzheimer's Disease

Recruiting at 21 trial locations
BS
BC
Fl
Overseen ByFirst line of the email MUST contain NCT # and Site #.
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?

This trial tests a new treatment, KarXT + KarX-EC (a potential new drug combination), to determine its effectiveness in reducing psychosis (seeing or hearing things that aren't there) in people with Alzheimer's disease. The study compares this treatment to a placebo to assess its effectiveness. Individuals diagnosed with Alzheimer's who have experienced psychotic symptoms for at least two months might be suitable candidates for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that KarXT + KarX-EC is likely to be safe for humans?

Research is examining the safety of KarXT + KarX-EC for treating Alzheimer's disease symptoms, such as psychosis and agitation. Earlier studies have explored its use for similar issues, including memory problems and agitation in Alzheimer's patients. These studies assess both the treatment's effectiveness and safety.

Results from these studies generally indicate that KarXT + KarX-EC is well-tolerated. Some side effects, typically mild to moderate, have been reported. For instance, patients might experience dry mouth or constipation, common with medications affecting the nervous system.

Overall, the ongoing research appears promising, suggesting that KarXT + KarX-EC might be a safe option for managing Alzheimer's-related symptoms. However, while the findings are encouraging, the studies are still in progress, and additional data will help confirm these results.12345

Why do researchers think this study treatment might be promising for Alzheimer's disease?

Researchers are excited about KarXT + KarX-EC for Alzheimer's Disease because it offers a novel approach to treatment. Unlike standard treatments, which often target amyloid plaques or tau proteins, KarXT + KarX-EC works on the muscarinic acetylcholine receptors in the brain. This method aims to enhance cognitive function differently by potentially improving memory and thinking skills directly. Additionally, this treatment could offer fewer side effects compared to traditional therapies, making it a promising candidate for improving the quality of life for individuals with Alzheimer's.

What evidence suggests that KarXT + KarX-EC might be an effective treatment for Alzheimer's disease psychosis?

Research has shown that KarXT, a combination of xanomeline and trospium, may help treat symptoms of Alzheimer's disease. Studies suggest it could improve cognitive abilities and reduce symptoms like agitation. Some findings indicate that KarXT can address both the positive and negative effects of cognitive impairment. Early data also suggest it might ease agitation in patients. While research continues, these initial results are promising for KarXT + KarX-EC, which participants in this trial may receive, as a treatment option for Alzheimer's-related psychosis.12345

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people aged 55 to 90 who have Alzheimer's disease and have experienced psychotic symptoms (like hallucinations or delusions) for at least two months. They must not have other major psychiatric disorders, recent major depression with psychosis, or brain conditions unrelated to Alzheimer's.

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.
See 1 more

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
See 1 more

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 for the treatment of psychosis associated with Alzheimer's disease

14 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • KarXT + KarX-EC

Trial Overview

The study is testing a combination of KarXT and KarX-EC compared to a placebo in treating psychosis linked to Alzheimer's disease. Participants are randomly assigned to receive either the active drugs or placebo.

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

Citations

Effectiveness of KarXT (xanomeline-trospium) for cognitive ...

These findings suggest that KarXT may have a separable and meaningful impact on cognition, particularly among patients with cognitive impairment.

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.

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.

A Study to Evaluate the Efficacy and Safety of KarXT + KarX ...

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease ; First Posted. May 16, 2025 ; Start. Jul 14, 2025.

NCT06976203 | A Study to Evaluate the Efficacy and ...

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