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RECRUITING
NCT06937229
PHASE3

A 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

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2025-12-02

Completion Date

2029-07-20

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

KarX-EC

Specified dose on specified days

Locations (240)

Local Institution - 2609

Chandler, Arizona, United States

Imaging Endpoints

Scottsdale, Arizona, United States

Local Institution - 1657

Anaheim, California, United States

Local Institution - 2620

Canoga Park, California, United States

Local Institution - 1637

La Jolla, California, United States

Local Institution - 2625

Long Beach, California, United States

Local Institution - 2607

Long Beach, California, United States

Local Institution - 2642

Long Beach, California, United States

Local Institution - 2613

Pasadena, California, United States

Local Institution - 1662

Pomona, California, United States

Local Institution - 1651

Walnut Creek, California, United States

Local Institution - 2602

Bonita Springs, Florida, United States

Local Institution - 2626

Hialeah, Florida, United States

Local Institution - 1602

Miami, Florida, United States

Local Institution - 1618

Miami, Florida, United States

Local Institution - 1609

Miami, 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

Local Institution - 1636

Gaithersburg, Maryland, United States

Boston Center for Memory

Newton, Massachusetts, United States

Local Institution - 2615

Worcester, Massachusetts, United States

Local Institution - 2618

Ann Arbor, Michigan, 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

Local Institution - 1649

Las Vegas, Nevada, United States

Local Institution - 1647

West Long Branch, 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

Local Institution - 1653

Columbia, South Carolina, 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

Pantheon Clinical Research, LLC

Bountiful, Utah, United States

Local Institution - 1646

Bennington, Vermont, United States

Local Institution - 1644

Seattle, Washington, United States

Local Institution - 1654

Spokane, Washington, United States

Local Institution - 2610

Milwaukee, Wisconsin, United States

Local Institution - 2005

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Local Institution - 1001

La Plata, Buenos Aires, Argentina

Local Institution - 1002

Mar del Plata, Buenos Aires, Argentina

Local Institution - 2006

Buenos Aires, Buenos Aires F.D., Argentina

Local Institution - 1006

Rosario, Santa Fe Province, Argentina

Local Institution - 2004

Buenos Aires, Argentina

Local Institution - 1003

Buenos Aires, Argentina

Local Institution - 1004

Córdoba, Argentina

Local Institution - 2000

Córdoba, Argentina

Local Institution - 2002

Córdoba, Argentina

Local Institution - 1005

Córdoba, Argentina

Local Institution - 1000

Córdoba, Argentina

Local Institution - 2003

Córdoba, Argentina

Local Institution - 2001

Mendoza, Argentina

Local Institution - 1051

Brasília, Federal District, Brazil

Local Institution - 1052

Curitiba, Paraná, Brazil

Local Institution - 1053

Curitiba, Paraná, Brazil

Local Institution - 1058

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 1054

Porto Alegre, Rio Grande do Sul, Brazil

Local Institution - 1057

Campinas, São Paulo, Brazil

Local Institution - 1050

Rio de Janeiro, Brazil

Local Institution - 1055

São Paulo, Brazil

Local Institution - 1056

São Paulo, Brazil

Local Institution - 1100

Sofia, Sofia-Grad, Bulgaria

Local Institution - 1101

Pleven, Bulgaria

Local Institution - 1103

Razgrad, Bulgaria

Local Institution - 1102

Varna, Bulgaria

Local Institution - 1153

Hamilton, Ontario, Canada

Local Institution - 1155

London, Ontario, Canada

Local Institution - 1151

Toronto, Ontario, Canada

Local Institution - 1154

Toronto, Ontario, Canada

Local Institution - 1152

Whitby, Ontario, Canada

Local Institution - 2055

Viña del Mar, Región de Valparaíso, Chile

Local Institution - 2051

Santiago, Santiago Metropolitan, Chile

Local Institution - 2052

Santiago, Santiago Metropolitan, Chile

Local Institution - 2054

Vitacura, Santiago Metropolitan, Chile

Local Institution - 2053

Antofagasta, Chile

Local Institution - 1553

Zagreb, City of Zagreb, Croatia

Local Institution - 1554

Rijeka, Croatia

Local Institution - 1551

Split, Croatia

Local Institution - 1552

Varaždin, Croatia

Local Institution - 1550

Zagreb, Croatia

Local Institution - 2107

Olomouc, Olomoucký kraj, Czechia

Local Institution - 2100

Prague, Praha 6, Czechia

Local Institution - 2106

Prague, Praha 8, Czechia

Local Institution - 2103

Brno, South Moravian, Czechia

Local Institution - 2101

Choceň, Czechia

Local Institution - 2104

Pilsen, Czechia

Local Institution - 2102

Prague, Czechia

Local Institution - 2105

Prague, Czechia

Local Institution - 2108

Rychnov nad Kněžnou, Czechia

Local Institution - 2150

Toulouse, Haute-Garonne, France

Local Institution - 2151

Villeurbanne, Rhône, France

Local Institution - 2153

Lille, France

Local Institution - 2156

Limoges, France

Local Institution - 2157

Montpellier, France

Local Institution - 2152

Paris, France

Local Institution - 2155

Strasbourg, France

Local Institution - 2201

Düsseldorf, Germany

Local Institution - 2205

Halle, Germany

Local Institution - 2206

Westerstede, Germany

Local Institution - 1200

Pátrai, Achaḯa, Greece

Local Institution - 1205

Athens, Attica, Greece

Local Institution - 1202

Athens, Attica, Greece

Local Institution - 1203

Chaïdári, Attikí, Greece

Local Institution - 0027

Athens, Greece

Local Institution - 1206

Athens, Greece

Local Institution - 1207

Athens, Greece

Local Institution - 1201

Ioannina, Greece

Local Institution - 1204

Thessaloniki, Greece

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 - 2255

Budapest, Hungary

Local Institution - 2251

Budapest, Hungary

Local Institution - 2253

Budapest, Hungary

Local Institution - 2252

Debrecen, Hungary

Local Institution - 1251

Hyderabad, Andhra Pradesh, India

Local Institution - 1255

Ahmedabad, Gujarat, India

Local Institution - 1252

Hyderabad, Telangana, India

Local Institution - 1254

Varanasi, Uttar Pradesh, India

Local Institution - 1250

Kolkata, West Bengal, India

Local Institution - 1256

Delhi, India

Local Institution - 1253

New Delhi, India

Local Institution - 2302

Petch Tikva, IL, Israel

Local Institution - 2301

Jerusalem, Israel

Local Institution - 2303

Netanya, Israel

Local Institution - 2305

Ramat Gan, Israel

Local Institution - 2300

Ramat Gan, Israel

Local Institution - 2304

Rishon Le'Tzion, Israel

Local Institution - 2351

Naples, Campania, Italy

Local Institution - 2354

Rome, Lazio, Italy

Local Institution - 2352

Rome, Lazio, Italy

Local Institution - 2353

Milan, Lombardy, Italy

Local Institution - 2350

Pisa, PI, Italy

Local Institution - 2356

Brescia, Italy

Local Institution - 2355

Isernia, Italy

Local Institution - 2357

Roma, Italy

Local Institution - 1301

Hadano, Kanagawa, Japan

Local Institution - 1307

Kawasaki, Kanagawa, Japan

Local Institution - 1304

Sakai, Osaka, Japan

National Hospital Organization Hizen Psychiatric Center

Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan

Rainbow and Sea Hospital

Karatsu-shi, Saga-ken, Japan

Local Institution - 1305

Bunkyo-ku, Tokyo, Japan

Kuramitsu Hospital

Fukuoka, Japan

Okayama City General Medical Center Okayama City Hospital

Okayama, Japan

Local Institution - 1308

Shimotsuke-shi, Tochigi, Japan

Local Institution - 1355

Saltillo, Coahuila, Mexico

Local Institution - 1356

Guadalajara, Jalisco, Mexico

Local Institution - 1363

Mexico City, Mexico City, Mexico

Local Institution - 1360

Mexico City, Mexico City, Mexico

Local Institution - 1364

Monterrey, Nuevo León, Mexico

Local Institution - 1350

Monterrey, Nuevo León, Mexico

Local Institution - 1361

Mexico City, Mexico

Local Institution - 1362

San Luis Potosí City, Mexico

Local Institution - 1352

Tlalnepantla, Mexico

Local Institution - 2450

Poznan, Greater Poland Voivodeship, Poland

Local Institution - 2454

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Local Institution - 2456

Chorzów, Poland

Local Institution - 2455

Katowice, Poland

Local Institution - 2451

Lublin, Poland

Local Institution - 2452

Lublin, Poland

Local Institution - 2453

Sochaczew, Poland

Local Institution - 1401

Coimbra, Portugal

Local Institution - 1402

Guimarães, Portugal

Local Institution - 1404

Lisbon, Portugal

Local Institution - 1403

Senhora da Hora, Portugal

Local Institution - 1400

Torres Vedras, Portugal

Local Institution - 1450

Bucharest, București, Romania

Local Institution - 1452

Bucharest, București, Romania

Local Institution - 1453

Bucharest, București, Romania

Local Institution - 1454

Bucharest, București, Romania

Local Institution - 1455

Bucharest, București, Romania

Local Institution - 1456

Bucharest, București, Romania

Local Institution - 1458

Bucharest, București, Romania

Local Institution - 1451

Bucharest, Romania

Local Institution - 1459

Bucharest, Romania

Local Institution - 1461

Constanța, Romania

Local Institution - 1457

Iași, Romania

Local Institution - 1460

Sanpetru /Brasov, Romania

Local Institution - 1462

Sibiu, Romania

Local Institution - 2401

Incheon, Incheon Gwang'yeogsi, South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 2403

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 2406

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Local Institution - 2400

Deagu, Taegu-Kwangyǒkshi, South Korea

Local Institution - 2409

Incheon, South Korea

Local Institution - 2402

Seoul, South Korea

Gangnam Severance Hospital, Yonsei University Health System

Seoul, South Korea

Local Institution - 2405

Seoul, South Korea

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

Seoul, South Korea

Local Institution - 1510

Getxo, Bizkaia, Spain

Local Institution - 1509

Elche (alicante), Spain

Local Institution - 1508

Madrid, Spain

Local Institution - 1505

Madrid, Spain

Local Institution - 0003

Málaga, Spain

Local Institution - 1502

Málaga, Spain

Local Institution - 1507

Pamplona, Spain

Local Institution - 1500

Salamanca, Spain

Local Institution - 1503

Seville, Spain

Local Institution - 1504

Terrassa, Spain

Local Institution - 1506

Valladolid, Spain

Local Institution - 1501

Zaragoza, Spain

Local Institution - 1753

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

Local Institution - 1751

Tainan, Taiana, Taiwan

Local Institution - 1754

Taipei, Taiwan

Local Institution - 1750

Taipei, Taiwan

Local Institution - 1752

Taoyuan District, Taiwan

Local Institution - 2555

Smila, Cherkasy Oblast, Ukraine

Local Institution - 2554

Dnipro, Dnipropetrovsk Oblast, Ukraine

Local Institution - 2566

Hlevakha, Kyiv Oblast, Ukraine

Local Institution - 2552

Lviv, Lviv Oblast, Ukraine

Local Institution - 2558

Lviv, Lviv Oblast, Ukraine

Local Institution - 2569

Lviv, Lviv Oblast, Ukraine

Local Institution - 2567

Oleksandrivka, Odesa Oblast, Ukraine

Local Institution - 2551

Vinnytsia, Vinnytsia Oblast, Ukraine

Local Institution - 2556

Hlevakha, Ukraine

Local Institution - 2550

Kropyvnytskyi, Ukraine

Local Institution - 2565

Kyiv, Ukraine

Local Institution - 2553

Kyiv, Ukraine

Local Institution - 2568

Odesa, Ukraine

Local Institution - 2557

Poltava, Ukraine

Local Institution - 2559

Skarzhyntsi, Ukraine

Local Institution - 2505

Preston, Lancashire, United Kingdom

Surrey and Borders Partnership NHS Foundation Trust

Chertsey, Surrey, United Kingdom

Local Institution - 2502

Cambridge, United Kingdom

Local Institution - 2501

London, United Kingdom

Local Institution - 2500

London, United Kingdom

Local Institution - 2510

Motherwell, United Kingdom

Local Institution - 2507

Redruth, United Kingdom

Local Institution - 2504

Sheffield, United Kingdom

Local Institution - 2509

Stafford, United Kingdom

Local Institution - 2503

Wolverhampton, United Kingdom