Phase 3 Study for Agitation in Alzheimer's Disease

This study, called ADAGIO-2, is looking at a treatment for agitation (restlessness or distress) in people with Alzheimer's disease. Researchers want to see how safe and effective two medications, KarXT + KarX-EC, are compared to a placebo (an inactive substance). You might be able to join if you are 55 to 90 years old, have an Alzheimer's diagnosis, and have specific evidence of Alzheimer's disease in your body, such as from a PET scan or spinal fluid tests. The main goal is to see if these medications reduce agitation after 14 weeks, measured by a special questionnaire. The study plans to enroll 352 people, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase 3 study and plans to include 352 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 14, indicating follow-up for at least that duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07011745

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Recruiting
PHASE3Ages 55–90InterventionalTreatment
Bristol-Myers Squibb
~426 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:Xanomeline/Trospium Chloride CapsuleXanomeline Enteric CapsulePlacebo

At a glance

Recruiting sites
94 of 144 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14
Measured over At Week 14
Alzheimer's Disease
144 sites across 68 states
Florida9
California8
Ukraine8
United Kingdom8
Poland7
Argentina6
Czechia5
France5
  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Amyloid PET.
Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
Mini-Mental State Examination (MMSE) score of ≤ 24 at Screening (Visit 1).
Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:
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).
Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score ≥ 30 at Screening (Visit 1) and Visit 2.
  • Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score at Week 14At Week 14