KarXT + KarX-EC for Alzheimer's Disease
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive KarXT + KarX-EC or placebo for the treatment of psychosis associated with Alzheimer's disease
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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
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 ...
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