Recruiting

KarXT + KarX-EC for Agitation in Alzheimer's Disease

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What is being tested

Xanomeline/Trospium Chloride Capsule

+ Xanomeline Enteric Capsule
+ Placebo
Drug
Who is being recruted

Alzheimer Disease

From 55 to 90 Years
+13 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Phase 3
Interventional
Study Start: July 2025

See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 10, 2025Actual date on which the first participant was enrolled.

This clinical trial aims to test a new treatment combination, KarXT + KarX-EC, for adults experiencing agitation due to Alzheimer's Disease. Agitation can be a significant concern for individuals with Alzheimer's, impacting their quality of life and increasing caregiver stress. By exploring the safety and effectiveness of this treatment, the study hopes to offer a new option for managing these symptoms, potentially improving the daily experiences of those affected by the disease. Participants in the study will receive either the treatment or a placebo, ensuring a controlled environment to accurately assess the outcomes. The treatment is administered in a way that allows researchers to observe its impact on agitation symptoms. The study's design ensures that participants' safety is closely monitored throughout the trial. By comparing results between the treatment and placebo groups, researchers aim to determine the overall benefits and any risks associated with KarXT + KarX-EC.

Official TitleA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease 
Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Last updated: November 5, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
352 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 55 to 90 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Alzheimer Disease
Criteria
7 inclusion criteria required to participate
History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):. i) 1 or more aggressive behaviors occurring several times per week. ii) 2 or more aggressive behaviors occurring once or twice per week. iii) 3 or more aggressive behaviors occurring less than once per week.
CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).
AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).

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6 exclusion criteria prevent from participating
Other protocol-defined Inclusion/Exclusion criteria apply.
History of bipolar disorder, schizophrenia, or schizoaffective disorder.
Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam). A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted. B. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
Group II
Placebo
Study Objectives
Primary Objectives

Secondary Objectives

As determined by CMAI-IPA changes of 30%, 40%, and 50% from baseline

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 153 locations
Recruiting
Imaging EndpointsScottsdale, United StatesSee the location
Recruiting
Kaizen Brain CenterLa Jolla, United States
Recruiting
Torrance Clinical ResearchTorrance, United States
Recruiting
Sunwise Clinical ResearchWalnut Creek, United States
Recruiting
153 Study Centers