Xanomeline + Trospium for Agitation in 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 combination of medications), to determine its effectiveness in reducing agitation in people with Alzheimer's Disease. Agitation may include restlessness, irritability, or aggressive outbursts. The study seeks participants diagnosed with Alzheimer's who have experienced agitation symptoms for at least two weeks. Participants must have a caregiver to assist with study requirements. The trial will compare the treatment's effects to a placebo (a pill with no active medicine) to evaluate its effectiveness and safety. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
You may need to stop taking certain medications like monoamine oxidase inhibitors, anticonvulsants, mood stabilizers, and tricyclic antidepressants. However, if you're on a stable dose of selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors for at least 8 weeks, you might be able to continue them. Mirtazapine or trazodone can also be used if started 8 weeks before the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of KarXT and KarX-EC is being tested for safety in people with Alzheimer's disease who experience agitation. In earlier studies, patients generally tolerated this treatment well. Some side effects appeared, but they were usually mild, with dry mouth and constipation being the most common. These studies did not identify any serious safety concerns.
This treatment is now in a phase 3 trial, indicating it has already passed earlier safety tests. While this does not guarantee complete safety, it does mean there is substantial safety information available. Always consult a healthcare provider if there are questions or concerns about joining a clinical trial.12345Why are researchers excited about this trial's treatments?
Xanomeline + Trospium is unique because it combines two active ingredients that target different pathways involved in Alzheimer's-related agitation. Xanomeline acts on muscarinic receptors in the brain, which are thought to play a role in cognitive function and mood regulation, while Trospium is used to counteract potential side effects associated with Xanomeline by acting as a peripheral anticholinergic. Unlike standard treatments that primarily focus on managing symptoms with antipsychotics or benzodiazepines, this combination aims to directly address the underlying mechanisms of agitation. Researchers are excited about its potential to offer a more targeted treatment with possibly fewer side effects, improving quality of life for individuals with Alzheimer's.
What evidence suggests that this trial's treatments could be effective for agitation in Alzheimer's Disease?
Research has shown that KarXT, a combination of xanomeline and trospium, may reduce restlessness in people with Alzheimer's disease. Studies have found that this combination can improve thinking and memory problems. Some patients have also experienced improvements in symptoms like hallucinations, which can occur with Alzheimer's. In this trial, participants will receive either the experimental treatment KarXT + KarX-EC or a placebo. The treatment targets specific brain areas related to memory and behavior, potentially calming restlessness. This approach aims to enhance brain function while minimizing side effects.36789
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 adults with Alzheimer's who experience agitation. Participants must have a caregiver, meet specific criteria for Alzheimer's diagnosis and agitation severity, and score within a certain range on the Mini-Mental State Examination. Those with bipolar disorder, schizophrenia, or at risk of suicide cannot join.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 agitation 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
- KarX-EC
- KarXT
Trial Overview
The study tests KarXT + KarX-EC to see if they're safe and effective in reducing agitation in Alzheimer's patients. It compares these treatments against a placebo (a substance with no active drug).
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
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.
2.
alz-journals.onlinelibrary.wiley.com
alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.075201Design of ADEPT‐2, a phase 3, parallel group study to ...
While xanomeline had promising efficacy for potentially treating psychosis in AD, cholinergic adverse events limited further clinical ...
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.
A Phase 3 Study to Evaluate the Safety and Efficacy of ...
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 Long-term Efficacy and Safety of ...
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride ...
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.
Trial ID CN012-0024 | NCT07011745 - BMS Clinical Trials
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.
8.
clinicaltrials.eu
clinicaltrials.eu/trial/study-of-trospium-chloride-and-xanomeline-tartrate-combination-for-agitation-in-alzheimers-disease-patients-long-term-safety-evaluation/Study of trospium chloride and xanomeline tartrate ...
This study focuses on testing medications called KarXT and KarX-EC in people who have Alzheimer's Disease with agitation.
KarXT + KarX-EC for Agitation in Alzheimer's Disease
This clinical trial aims to test a new treatment combination, KarXT + KarX-EC, for adults experiencing agitation due to Alzheimer's Disease.
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