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

Recruiting · NCT06937229 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb

View the official record on ClinicalTrials.gov →

Alzheimer's disease

Interventions studied

KarX-EC KarXT

What this trial is about

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.

Who can take part

Age range

55 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 20 US states.

Local Institution - 2609 - Chandler, Arizona, United States
Imaging Endpoints - Scottsdale, Arizona, United States
Local Institution - 1657 - Anaheim, California, United States
Local Institution - 1668 - Fresno, California, United States
Local Institution - 2625 - Long Beach, California, United States
Local Institution - 2642 - Long Beach, California, United States
Local Institution - 2649 - Orange, California, United States
Local Institution - 2613 - Pasadena, California, United States
Local Institution - 1662 - Pomona, California, United States
Local Institution - 1639 - Torrance, California, United States
Local Institution - 1651 - Walnut Creek, California, United States
Local Institution - 2602 - Bonita Springs, Florida, United States
Nuovida Research Center - Miami, Florida, United States
Local Institution - 1635 - Orlando, Florida, United States
Progressive Medical Research - Port Orange, Florida, United States
IPTB Clinical Research - Tampa, Florida, United States
Hope Research Network - Miami - Virginia Gardens, Florida, United States
Local Institution - 2611 - Atlanta, Georgia, United States
Local Institution - 1636 - Gaithersburg, Maryland, United States
Boston Center for Memory - Newton, Massachusetts, United States
Local Institution - 2615 - Worcester, Massachusetts, United States
Local Institution - 1620 - Troy, Michigan, United States
Local Institution - 2256 - Saint Paul, Minnesota, United States
Local Institution - 2629 - Hattiesburg, Mississippi, United States
Local Institution - 2628 - Las Vegas, Nevada, United States
Redbird Research - Las Vegas, Nevada, United States
Local Institution - 1664 - Princeton, New Jersey, United States
Local Institution - 1656 - New Windsor, New York, United States
Local Institution - 2619 - Staten Island, New York, United States
Local Institution - 1658 - Woodmere, New York, United States
West Clinical Research - Morehead City, North Carolina, United States
Local Institution - 2617 - Blue Ash, Ohio, United States
Local Institution - 1640 - Tulsa, Oklahoma, United States
Epic Medical Research, LLC - Carrolton - Carrollton, Texas, United States
Local Institution - 2605 - Cypress, Texas, United States
Local Institution - 1643 - El Paso, Texas, United States
Local Institution - 2622 - Mesquite, Texas, United States
Local Institution - 2623 - San Antonio, Texas, United States
Local Institution - 2612 - Bountiful, Utah, United States
Local Institution - 1646 - Bennington, Vermont, United States
Local Institution - 1644 - Seattle, Washington, United States
Local Institution - 2610 - Milwaukee, Wisconsin, United States
Local Institution - 2053 - Antofagasta, Chile
Local Institution - 0027 - Athens, Greece
Local Institution - 1206 - Athens, Greece
Local Institution - 1207 - Athens, Greece
Local Institution - 2356 - Brescia, Italy
Local Institution - 1451 - Bucharest, Romania
Local Institution - 1463 - Bucharest, Romania
Local Institution - 1459 - Bucharest, Romania
Local Institution - 2255 - Budapest, Hungary
Local Institution - 2251 - Budapest, Hungary
Local Institution - 2253 - Budapest, Hungary
Local Institution - 2004 - Buenos Aires, Argentina
Local Institution - 1003 - Buenos Aires, Argentina
Local Institution - 2502 - Cambridge, United Kingdom
Local Institution - 2101 - Choceň, Czechia
Local Institution - 2456 - Chorzów, Poland
Local Institution - 1401 - Coimbra, Portugal
Local Institution - 1461 - Constanța, Romania

Showing 60 of 252 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →