RecruitingPhase 3NCT07011745

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Sponsor

Bristol-Myers Squibb

Enrollment

352 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.

Eligibility

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This trial (ADAGIO-2) is a second Phase 3 study testing the same combination — KarXT plus KarX-EC — for reducing agitation in people with Alzheimer's disease. Running a second identical trial allows researchers to independently confirm the results from ADAGIO-1. **You may be eligible if...** - You have a confirmed diagnosis of Alzheimer's disease, supported by a brain scan, spinal fluid test, or blood biomarker - You have clinically significant agitation assessed by a specialist - You live in a stable care setting (home, assisted living, or nursing facility) **You may NOT be eligible if...** - Your agitation is thought to be caused by another condition or medication - You have recently had a stroke or significant cardiac event - You are already taking medications that are known to interact with this drug - Your Alzheimer's is in the very earliest or most advanced stage Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXanomeline/Trospium Chloride Capsule

Specified dose on specified days

DRUGXanomeline Enteric Capsule

Specified dose on specified days

DRUGPlacebo

Specified dose on specified days

Locations(140)

Chandler Clinical Trials, LLC

Chandler, Arizona, United States

Local Institution - 2631

Chandler, Arizona, United States

National Institute of Clinical Research

Garden Grove, California, United States

Local Institution - 2607

Long Beach, California, United States

Accellacare

Long Beach, California, United States

Local Institution - 2627

Napa, California, United States

Local Institution - 2613

Pasadena, California, United States

Local Institution - 2614

San Diego, California, United States

Alliance Clinical -West Hills

West Hills, California, United States

Local Institution - 2601

Basalt, Colorado, United States

Local Institution - 2635

Colorado Springs, Colorado, United States

Local Institution - 2632

Norwalk, Connecticut, United States

Envision Trials LLC

Bonita Springs, Florida, United States

Key Clinical Research

Bradenton, Florida, United States

Local Institution - 2636

Doral, Florida, United States

Local Institution - 2606

Homestead, Florida, United States

Local Institution - 2633

Miami, Florida, United States

Local Institution - 2637

Miami, Florida, United States

Local Institution - 2634

Orlando, Florida, United States

IPTB Clinical Research

Tampa, Florida, United States

Agile Clinical Research Trials, LLC

Atlanta, Georgia, United States

Vitalix Clinical

Worcester, Massachusetts, United States

Michigan Clinical Research Institute PC

Ann Arbor, Michigan, United States

Local Institution - 2630

Saint Paul, Minnesota, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Local Institution - 2603

Ozark, Missouri, United States

Las Vegas Clinical Trials

Las Vegas, Nevada, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Local Institution - 2644

Valley Stream, New York, United States

West Clinical Research

Morehead City, North Carolina, United States

Velocity Clinical Research - Blue Ash

Blue Ash, Ohio, United States

Epic Medical Research, LLC - Carrolton

Carrollton, Texas, United States

Horizon Clinical Research Center - Houston

Cypress, Texas, United States

Epic Medical Research, LLC - Mesquite

Mesquite, Texas, United States

UT Health - San Antonio

San Antonio, Texas, United States

Local Institution - 2612

Bountiful, Utah, United States

Local Institution - 2638

Kirkland, Washington, United States

Local Institution - 2610

Milwaukee, Wisconsin, United States

Local Institution - 2005

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM

Buenos Aires, Argentina

Local Institution - 2004

Buenos Aires, Argentina

Local Institution - 2000

Córdoba, Argentina

Local Institution - 2002

Córdoba, Argentina

Local Institution - 2003

Córdoba, Argentina

Local Institution - 2001

Mendoza, Argentina

Local Institution - 2051

Santiago, Santiago Metropolitan, Chile

Local Institution - 2050

Santiago, Santiago Metropolitan, Chile

Local Institution - 2052

Santiago, Santiago Metropolitan, Chile

Local Institution - 2054

Vitacura, Santiago Metropolitan, Chile

Local Institution - 2055

Viña del Mar, Valparaiso, Chile

Local Institution - 2053

Antofagasta, Chile

AGE Centrum

Olomouc, Olomouc Region, Czechia

Neuropsychiatrie

Prague, Praha 6, Czechia

Institut neuropsychiatricke pece (INEP), Praha

Prague, Praha 8, Czechia

Neuro Health Centrum s.r.o.

Brno, South Moravian, Czechia

NEUROHK

Choceň, Czechia

A-SHINE s.r.o.

Pilsen, Czechia

Local Institution - 2102

Prague, Czechia

Local Institution - 2105

Prague, Czechia

Vestra Clinics s.r.o.

Rychnov nad Kněžnou, Czechia

Centre Hospitalier Universitaire Toulouse - Cité de la Santé

Toulouse, Haute-Garonne, France

Hôpital des Charpennes - Hospices Civils de Lyon (HCL)

Villeurbanne, Rhône, France

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

Lille, France

Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren

Limoges, France

Hopital Gui Chauliac - Chu Montpellier

Montpellier, France

Centres Memoire de Ressources et de Recherche (CMRR) - Hopital Lariboisiere-Fernand-Widal Location

Paris, France

Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau

Strasbourg, France

Local Institution - 2201

Düsseldorf, Germany

Local Institution - 2205

Halle, Germany

Local Institution - 2206

Westerstede, Germany

Local Institution - 2257

Kalocsa, Bács-Kiskun county, Hungary

Local Institution - 2250

Győr, Győr-Moson-Sopron, Hungary

Local Institution - 2254

Gyöngyös, Heves County, Hungary

Local Institution - 2256

Budapest, Hungary

Local Institution - 2255

Budapest, Hungary

Local Institution - 2251

Budapest, Hungary

Local Institution - 2253

Budapest, Hungary

Local Institution - 2252

Debrecen, Hungary

The Chaim Sheba Medical Center

Ramat Gan, Central District, Israel

Local Institution - 2302

Petch Tikva, IL, Israel

Local Institution - 2301

Jerusalem, Israel

Sanz MC, Laniado Hospital

Netanya, Israel

The Israeli Alzheimer Medical Center

Ramat Gan, Israel

Bayit Balev Ltd.

Rishon Le'Tzion, Israel

University of Naples Federico II

Naples, Campania, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155

Rome, Lazio, Italy

Azienda Ospedaliero-Universitaria Sant'Andrea

Rome, Lazio, Italy

Auxologico IRCCS - Auxologico San Luca

Milan, Lombardy, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, PI, Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Local Institution - 2355

Isernia, Italy

Fondazione Policlinico Gemelli IRCCS

Roma, Italy

Centrum Medyczne HCP Szpital im. Jana Pawla II

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne NEUROMED

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

M2M Med

Chorzów, Poland

Centrum In Psyche Spersonalizowanej Psychiatrii I Terapii

Katowice, Poland

Local Institution - 2451

Lublin, Poland

Local Institution - 2452

Lublin, Poland

RCMed Oddzial Sochaczew

Sochaczew, Poland

Local Institution - 2641

San Juan, Puerto Rico

Local Institution - 2640

San Juan, Puerto Rico

Local Institution - 2639

San Juan, Puerto Rico

Local Institution - 2645

San Juan, Puerto Rico

Inha University Hospital

Incheon, Incheon Gwang'yeogsi, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 2406

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Kyungpook National University Chilgok Hospital

Deagu, Taegu-Kwangyǒkshi, South Korea

Gachon University Gil Medical Center

Incheon, South Korea

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea

SMG-SNU Borame Medical Center

Seoul, South Korea

The Catholic University of Korea, Yeouido St.Mary's Hospital

Seoul, South Korea

CNCE "Cherkasy regional psychiatric hospital of Cherkasy regional council"

Smila, Cherkasy Oblast, Ukraine

MNCC Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC

Dnipro, Dnipropetrovsk Oblast, Ukraine

Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council

Skarzhyntsi, Khmelnytskyi Oblast, Ukraine

CNCE of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"

Hlevakha, Kyiv Oblast, Ukraine

CNCE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"

Lviv, Lviv Oblast, Ukraine

CNCE "Odesa Regional Mental Health Medical Center" of the ORC"

Oleksandrivka, Odesa Oblast, Ukraine

Local Institution - 2562

Ternopil, Ternopil Oblast, Ukraine

CNPE "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. Acad. O.I. Yushchenko of Vinnytsia Regional Counsil"

Vinnytsia, Vinnytsia Oblast, Ukraine

Local Institution - 2560

Lutsk, Volyn Oblast, Ukraine

Local Institution - 2556

Hlevakha, Ukraine

Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad RC

Kropyvnytskyi, Ukraine

Local Institution - 2565

Kyiv, Ukraine

Local Institution - 2553

Kyiv, Ukraine

"Medical Centre "Neuroclinic" LLC

Lviv, Ukraine

Local Institution - 2569

Lviv, Ukraine

Local Institution - 2568

Odesa, Ukraine

Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"

Poltava, Ukraine

Lancashire & South Cumbria NHS Foundation Trust

Preston, Lancashire, United Kingdom

Surrey and Borders Partnership NHS Foundation Trust

Chertsey, Surrey, United Kingdom

Local Institution - 2502

Cambridge, United Kingdom

South London and Maudsley NHS Foundation Trust

London, United Kingdom

Local Institution - 2500

London, United Kingdom

NeuroClin Glasgow

Motherwell, United Kingdom

Cornwall Partnership NHS Foundation Trust

Redruth, United Kingdom

Sheffield Health and Social care NHS Foundation Trust

Sheffield, United Kingdom

Local Institution - 2509

Stafford, United Kingdom

Local Institution - 2503

Wolverhampton, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07011745

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