Home › Alzheimer's Disease › NCT06937229
A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
RecruitingPhase 3
A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)
Who can join
Ages 55 to 90 · All sexes
Full eligibility criteria
Inclusion Criteria:
* Participants must have completed study CN012-0023 or CN012-0024 per protocol.
* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).
Exclusion Criteria:
* Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
* Other protocol-defined Inclusion/Exclusion criteria apply.
About the study
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.
What is being tested
- KarXT (drug)
- KarX-EC (drug)
Sponsor: Bristol-Myers Squibb · Participants: 650 · Started: Dec 2, 2025
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT06937229
Locations in the U.S.
| Arizona | Local Institution - 2609, Chandler (Not yet recruiting)
Imaging Endpoints, Scottsdale |
| California | Local Institution - 1657, Anaheim (Not yet recruiting)
Local Institution - 1668, Fresno (Not yet recruiting)
Local Institution - 2625, Long Beach (Not yet recruiting)
Local Institution - 2642, Long Beach (Not yet recruiting)
Local Institution - 2649, Orange (Not yet recruiting)
Local Institution - 2613, Pasadena (Not yet recruiting)
Local Institution - 1662, Pomona (Not yet recruiting)
Local Institution - 1639, Torrance (Not yet recruiting)
Local Institution - 1651, Walnut Creek (Not yet recruiting) |
| Florida | Local Institution - 2602, Bonita Springs (Not yet recruiting)
Nuovida Research Center, Miami
Local Institution - 1635, Orlando (Not yet recruiting)
Progressive Medical Research, Port Orange
IPTB Clinical Research, Tampa
Hope Research Network - Miami, Virginia Gardens |
| Georgia | Local Institution - 2611, Atlanta (Not yet recruiting) |
| Maryland | Local Institution - 1636, Gaithersburg (Not yet recruiting) |
| Massachusetts | Boston Center for Memory, Newton
Local Institution - 2615, Worcester (Not yet recruiting) |
| Michigan | Local Institution - 1620, Troy (Not yet recruiting) |
| Minnesota | Local Institution - 2256, Saint Paul (Not yet recruiting) |
| Mississippi | Local Institution - 2629, Hattiesburg (Not yet recruiting) |
| Nevada | Local Institution - 2628, Las Vegas (Not yet recruiting)
Redbird Research, Las Vegas |
| New Jersey | Local Institution - 1664, Princeton (Not yet recruiting) |
| New York | Local Institution - 1656, New Windsor (Not yet recruiting)
Local Institution - 2619, Staten Island (Not yet recruiting)
Local Institution - 1658, Woodmere (Not yet recruiting) |
| North Carolina | West Clinical Research, Morehead City |
| Ohio | Local Institution - 2617, Blue Ash (Not yet recruiting) |
| Oklahoma | Local Institution - 1640, Tulsa (Not yet recruiting) |
| Texas | Epic Medical Research, LLC - Carrolton, Carrollton
Local Institution - 2605, Cypress (Not yet recruiting)
Local Institution - 1643, El Paso (Not yet recruiting)
Local Institution - 2622, Mesquite (Not yet recruiting)
Local Institution - 2623, San Antonio (Not yet recruiting) |
| Vermont | Local Institution - 1646, Bennington (Not yet recruiting) |
| Washington | Local Institution - 1644, Seattle (Not yet recruiting) |
| Wisconsin | Local Institution - 2610, Milwaukee (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.