Recruiting

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Xanomeline/Trospium Chloride Capsule

+ Xanomeline Enteric Capsule

+ Placebo

Drug
Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

From 55 to 90 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: July 2025
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: March 25, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 10, 2025

Actual 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
NCT07011732
Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: March 25, 2026
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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 55 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

Criteria

9 inclusion criteria required to participate
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 at least several times per week. ii) 2 or more aggressive behaviors occurring at least once or twice per week. iii) 3 or more aggressive behaviors occurring less than once per week.
Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).
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).
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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8 exclusion criteria prevent from participating
ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder.
iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
Prior/Concomitant Therapy: i) 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).
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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

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 157 locations

Recruiting

Imaging Endpoints

Scottsdale, United StatesOpen Imaging Endpoints in Google Maps
Recruiting

Advanced Research Center (ARC) - Anaheim

Anaheim, United States
Recruiting

Kaizen Brain Center

La Jolla, United States
Recruiting

The Neurology Group

Pomona, United States
Recruiting
157 Study Centers