Recruiting

Phase 3

KarXT & KarX-ECA Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

Sponsor:

Bristol-Myers Squibb

Code:

NCT06937229

Conditions

Alzheimer Disease

Agitation

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

KarXT

KarX-EC

Study Details

Brief summary:

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.

Conditions

Alzheimer Disease

Agitation

Study ID

NCT06937229

Start date

Dec 2, 2025

Status verified date

Aug, 2026

Completion date

Jul 20, 2029

Anticipated

Primary completion date

Jun 22, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

650 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT+KarX-EC

Interventions

KarXT

Specified dose on specified days

KarX-EC

Specified dose on specified days

Primary outcome measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately Week 30 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

855-907-3286 Clinical.Trials@bms.com

Locations

Imaging Endpoints

Recruiting

Scottsdale, Arizona, United States, 85258

Contacts

Nida Laurin, Site 1619

480-290-1547

Nuovida Research Center

Recruiting

Miami, Florida, United States, 33186

Contacts

Jorge Betancourt, MD, Site 1604

786-616-9853

Progressive Medical Research

Recruiting

Port Orange, Florida, United States, 32127

Contacts

Alexander White, Site 1612

386-304-7070

IPTB Clinical Research

Recruiting

Tampa, Florida, United States, 33629

Contacts

Jamie Fernandez, Site 2621

813-251-1800

Hope Research Network - Miami

Recruiting

Virginia Gardens, Florida, United States, 33166

Contacts

Jorge Jorge, Site 1609

786-681-4959

Boston Center for Memory

Recruiting

Newton, Massachusetts, United States, 02459

Contacts

Paul Solomon, Site 1638

413-281-0577

Redbird Research

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Jelena Kunovac, Site 1649

760-758-2222

West Clinical Research

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Patrick Morgante, Site 2608

252-515-0050

Epic Medical Research, LLC - Carrolton

Recruiting

Carrollton, Texas, United States, 75006

Contacts

Andrea Brown, Site 2616

972-782-2405

Pantheon Clinical Research, LLC

Recruiting

Bountiful, Utah, United States, 84010

Contacts

Jackson Rhudy, Site 2612

801-200-3950

Ontario Shores Centre For Mental Health Sciences

Recruiting

Whitby, Ontario, Canada, L1N 5S9

Contacts

Amer Burhan, Site 1152

905-430-4055 x6268

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

Agitation
Alzheimer disease
KarXT
KarX-EC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-08-19.