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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
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
Conditions
Interventions
KarXT
Specified dose on specified days
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