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

NCT06937229 · tracked via the Priya Life Science USA tracker

Sponsor

Bristol-Myers Squibb

Phase

Phase 3

Started

2025-12-02

Last updated

2026-09-16

Condition(s) studied

Alzheimer DiseaseAgitation

Investigational drug(s) / intervention(s)

KarXTKarX-EC

KarXT: Specified dose on specified days

KarX-EC: Specified dose on specified days

Study 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.

Eligibility

Sex

ALL

Min age

55 Years

Max age

90 Years

Healthy volunteers

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.

Primary outcome measure(s)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) — Up to approximately Week 30

Trial sites (252)

Facility	City	Region	Status
Local Institution - 2609	Chandler	Arizona	Not Yet Recruiting
Imaging Endpoints	Scottsdale	Arizona	Recruiting
Local Institution - 1657	Anaheim	California	Not Yet Recruiting
Local Institution - 1668	Fresno	California	Not Yet Recruiting
Local Institution - 2625	Long Beach	California	Not Yet Recruiting
Local Institution - 2642	Long Beach	California	Not Yet Recruiting
Local Institution - 2649	Orange	California	Not Yet Recruiting
Local Institution - 2613	Pasadena	California	Not Yet Recruiting
Local Institution - 1662	Pomona	California	Not Yet Recruiting
Local Institution - 1639	Torrance	California	Not Yet Recruiting
Local Institution - 1651	Walnut Creek	California	Not Yet Recruiting
Local Institution - 2602	Bonita Springs	Florida	Not Yet Recruiting
Nuovida Research Center	Miami	Florida	Recruiting
Local Institution - 1635	Orlando	Florida	Not Yet Recruiting
Progressive Medical Research	Port Orange	Florida	Recruiting
IPTB Clinical Research	Tampa	Florida	Recruiting
Hope Research Network - Miami	Virginia Gardens	Florida	Recruiting
Local Institution - 2611	Atlanta	Georgia	Not Yet Recruiting
Local Institution - 1636	Gaithersburg	Maryland	Not Yet Recruiting
Boston Center for Memory	Newton	Massachusetts	Recruiting
Local Institution - 2615	Worcester	Massachusetts	Not Yet Recruiting
Local Institution - 1620	Troy	Michigan	Not Yet Recruiting
Local Institution - 2256	Saint Paul	Minnesota	Not Yet Recruiting
Local Institution - 2629	Hattiesburg	Mississippi	Not Yet Recruiting
Local Institution - 2628	Las Vegas	Nevada	Not Yet Recruiting
Redbird Research	Las Vegas	Nevada	Recruiting
Local Institution - 1664	Princeton	New Jersey	Not Yet Recruiting
Local Institution - 1656	New Windsor	New York	Not Yet Recruiting
Local Institution - 2619	Staten Island	New York	Not Yet Recruiting
Local Institution - 1658	Woodmere	New York	Not Yet Recruiting
West Clinical Research	Morehead City	North Carolina	Recruiting
Local Institution - 2617	Blue Ash	Ohio	Not Yet Recruiting
Local Institution - 1640	Tulsa	Oklahoma	Not Yet Recruiting
Epic Medical Research, LLC - Carrolton	Carrollton	Texas	Recruiting
Local Institution - 2605	Cypress	Texas	Not Yet Recruiting
Local Institution - 1643	El Paso	Texas	Not Yet Recruiting
Local Institution - 2622	Mesquite	Texas	Not Yet Recruiting
Local Institution - 2623	San Antonio	Texas	Not Yet Recruiting
Local Institution - 2612	Bountiful	Utah	Completed
Local Institution - 1646	Bennington	Vermont	Not Yet Recruiting

+ 212 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06937229 on ClinicalTrials.gov ↗ ← All trials in the USA