NCT06937229From ClinicalTrials.govRecruiting

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-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)

Alzheimer Disease
Agitation

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Bristol-Myers Squibb
Enrolment target: 650
Started: 2 December 2025
Main results due: 22 June 2029
Study sites: 252
Registry updated: 28 September 2026

Can you take part?

Ages 55 years to 90 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(252)

Local Institution - 2609
Chandler, Arizona, United States
Not yet recruiting
Imaging Endpoints
Scottsdale, Arizona, United States
Recruiting
Local Institution - 1657
Anaheim, California, United States
Not yet recruiting
Local Institution - 1668
Fresno, California, United States
Not yet recruiting
Local Institution - 2625
Long Beach, California, United States
Not yet recruiting
Local Institution - 2642
Long Beach, California, United States
Not yet recruiting
Local Institution - 2649
Orange, California, United States
Not yet recruiting
Local Institution - 2613
Pasadena, California, United States
Not yet recruiting
Local Institution - 1662
Pomona, California, United States
Not yet recruiting
Local Institution - 1639
Torrance, California, United States
Not yet recruiting
Local Institution - 1651
Walnut Creek, California, United States
Not yet recruiting
Local Institution - 2602
Bonita Springs, Florida, United States
Not yet recruiting
Nuovida Research Center
Miami, Florida, United States
Recruiting
Local Institution - 1635
Orlando, Florida, United States
Not yet recruiting
Progressive Medical Research
Port Orange, Florida, United States
Recruiting
IPTB Clinical Research
Tampa, Florida, United States
Recruiting
Hope Research Network - Miami
Virginia Gardens, Florida, United States
Recruiting
Local Institution - 2611
Atlanta, Georgia, United States
Not yet recruiting
Local Institution - 1636
Gaithersburg, Maryland, United States
Not yet recruiting
Boston Center for Memory
Newton, Massachusetts, United States
Recruiting
Local Institution - 2615
Worcester, Massachusetts, United States
Not yet recruiting
Local Institution - 1620
Troy, Michigan, United States
Not yet recruiting
Local Institution - 2256
Saint Paul, Minnesota, United States
Not yet recruiting
Local Institution - 2629
Hattiesburg, Mississippi, United States
Not yet recruiting
Local Institution - 2628
Las Vegas, Nevada, United States
Not yet recruiting
Redbird Research
Las Vegas, Nevada, United States
Recruiting
Local Institution - 1664
Princeton, New Jersey, United States
Not yet recruiting
Local Institution - 1656
New Windsor, New York, United States
Not yet recruiting
Local Institution - 2619
Staten Island, New York, United States
Not yet recruiting
Local Institution - 1658
Woodmere, New York, United States
Not yet recruiting
West Clinical Research
Morehead City, North Carolina, United States
Recruiting
Local Institution - 2617
Blue Ash, Ohio, United States
Not yet recruiting
Local Institution - 1640
Tulsa, Oklahoma, United States
Not yet recruiting
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, United States
Recruiting
Local Institution - 2605
Cypress, Texas, United States
Not yet recruiting
Local Institution - 1643
El Paso, Texas, United States
Not yet recruiting
Local Institution - 2622
Mesquite, Texas, United States
Not yet recruiting
Local Institution - 2623
San Antonio, Texas, United States
Not yet recruiting
Local Institution - 2612
Bountiful, Utah, United States
Completed
Local Institution - 1646
Bennington, Vermont, United States
Not yet recruiting
Local Institution - 1644
Seattle, Washington, United States
Not yet recruiting
Local Institution - 2610
Milwaukee, Wisconsin, United States
Not yet recruiting
Local Institution - 2005
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Not yet recruiting
Local Institution - 1001
La Plata, Buenos Aires, Argentina
Not yet recruiting
Local Institution - 1002
Mar del Plata, Buenos Aires, Argentina
Not yet recruiting
Local Institution - 2006
Buenos Aires, Buenos Aires F.D., Argentina
Not yet recruiting
Local Institution - 1006
Rosario, Santa Fe Province, Argentina
Not yet recruiting
Local Institution - 2004
Buenos Aires, Argentina
Not yet recruiting
Local Institution - 1003
Buenos Aires, Argentina
Not yet recruiting
Local Institution - 1004
Córdoba, Argentina
Not yet recruiting
Local Institution - 2000
Córdoba, Argentina
Not yet recruiting
Local Institution - 2002
Córdoba, Argentina
Not yet recruiting
Local Institution - 1005
Córdoba, Argentina
Not yet recruiting
Local Institution - 1000
Córdoba, Argentina
Not yet recruiting
Local Institution - 2003
Córdoba, Argentina
Not yet recruiting
Local Institution - 2001
Mendoza, Argentina
Not yet recruiting
Local Institution - 1051
Brasília, Federal District, Brazil
Not yet recruiting
Local Institution - 1052
Curitiba, Paraná, Brazil
Not yet recruiting
Local Institution - 1053
Curitiba, Paraná, Brazil
Not yet recruiting
Local Institution - 1058
Porto Alegre, Rio Grande do Sul, Brazil
Not yet recruiting

Showing 60 of 252 sites — filter to narrow it down. 51 of the 252 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06937229. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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