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
+14 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.comMore contacts
Last updated: January 24, 2026
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 
NCT07011732
Principal SponsorBristol-Myers Squibb
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: January 24, 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 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
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Dementia
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Tauopathies
Criteria
7 inclusion criteria required to participate
Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to: i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.
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).

Show More Criteria

7 exclusion criteria prevent from participating
Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors not taken at a stable dose for at least 8 weeks prior to Screening (Visit 1).
Mirtazapine or trazodone not used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.

Show More Criteria

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

Specified dose on specified days

Specified dose on specified days
Group II
Placebo

Specified dose on specified days
Study 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 158 locations
Recruiting
Imaging EndpointsScottsdale, United StatesSee the location
Recruiting
Advanced Research Center (ARC) - AnaheimAnaheim, United States
Recruiting
Kaizen Brain CenterLa Jolla, United States
Recruiting
Torrance Clinical ResearchTorrance, United States
Recruiting
158 Study Centers
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