A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
Start Date
12/2/2025
Completion Date
7/20/2029
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 Criteria
Age Range: 55 years to 90 years
Interventions
KarXT
KarX-EC
Conditions
Locations
Local Institution - 2609
Chandler, Arizona 85224
United States
Imaging Endpoints
Scottsdale, Arizona 85258
United States
Local Institution - 1657
Anaheim, California 92805
United States
Local Institution - 2620
Canoga Park, California 91303
United States
Local Institution - 1637
La Jolla, California 92037
United States
Local Institution - 2625
Long Beach, California 90040
United States
Local Institution - 2607
Long Beach, California 90805
United States
Local Institution - 2642
Long Beach, California 90807
United States
Local Institution - 2649
Orange, California 92866
United States
Local Institution - 2613
Pasadena, California 91105
United States
Local Institution - 1662
Pomona, California 91767
United States
Local Institution - 1639
Torrance, California 90505
United States
Local Institution - 1651
Walnut Creek, California 94596
United States
Local Institution - 2602
Bonita Springs, Florida 34134-4154
United States
Local Institution - 2626
Hialeah, Florida 33012
United States
Local Institution - 1618
Miami, Florida 33135
United States
Nuovida Research Center
Miami, Florida 33186
United States
Local Institution - 1635
Orlando, Florida 32807
United States
Progressive Medical Research
Port Orange, Florida 32127
United States
IPTB Clinical Research
Tampa, Florida 33629
United States
Hope Research Network - Miami
Virginia Gardens, Florida 33166
United States
Local Institution - 2611
Atlanta, Georgia 30328
United States
Local Institution - 1636
Gaithersburg, Maryland 20877
United States
Boston Center for Memory
Newton, Massachusetts 02459
United States
Local Institution - 2615
Worcester, Massachusetts 01608
United States
Local Institution - 2618
Ann Arbor, Michigan 48105
United States
Local Institution - 1620
Troy, Michigan 48085
United States
Local Institution - 2256
Saint Paul, Minnesota 55130
United States
Local Institution - 2629
Hattiesburg, Mississippi 39402
United States
Local Institution - 2628
Las Vegas, Nevada 89030
United States
Redbird Research
Las Vegas, Nevada 89119
United States
Local Institution - 1664
Princeton, New Jersey 08540
United States
Local Institution - 1656
New Windsor, New York 12553
United States
Local Institution - 2619
Staten Island, New York 10312
United States
Local Institution - 1658
Woodmere, New York 11598-1739
United States
West Clinical Research
Morehead City, North Carolina 28557
United States
Local Institution - 2617
Blue Ash, Ohio 45242
United States
Local Institution - 1640
Tulsa, Oklahoma 74136
United States
Epic Medical Research, LLC - Carrolton
Carrollton, Texas 75006
United States
Local Institution - 2605
Cypress, Texas 77429
United States
Local Institution - 1643
El Paso, Texas 79912
United States
Local Institution - 2622
Mesquite, Texas 75150
United States
Local Institution - 2623
San Antonio, Texas 78229
United States
Pantheon Clinical Research, LLC
Bountiful, Utah 84010
United States
Local Institution - 1646
Bennington, Vermont 05201-9810
United States
Local Institution - 1644
Seattle, Washington 98122
United States
Local Institution - 1654
Spokane, Washington 99201
United States
Local Institution - 2610
Milwaukee, Wisconsin 53226
United States
Local Institution - 2005
Ciudad Autonoma de Buenos Aires, Buenos Aires 1058
Argentina
Local Institution - 1001
La Plata, Buenos Aires 1900
Argentina
Local Institution - 1002
Mar del Plata, Buenos Aires B7602CBM
Argentina
Local Institution - 2006
Buenos Aires, Buenos Aires F.D. 1133
Argentina
Local Institution - 1006
Rosario, Santa Fe Province S2000
Argentina
Local Institution - 2004
Buenos Aires, 1199
Argentina
Local Institution - 1003
Buenos Aires, C1428AQK
Argentina
Local Institution - 1004
Córdoba, 5000
Argentina
Local Institution - 2000
Córdoba, 5000
Argentina
Local Institution - 2002
Córdoba, 5000
Argentina
Local Institution - 1005
Córdoba, 5004
Argentina
Local Institution - 1000
Córdoba, 5006
Argentina
Local Institution - 2003
Córdoba, X5003DCE
Argentina
Local Institution - 2001
Mendoza, 5502
Argentina
Local Institution - 1051
Brasília, Federal District 70200730
Brazil
Local Institution - 1052
Curitiba, Paraná 80230-130
Brazil
Local Institution - 1053
Curitiba, Paraná 80240-280
Brazil
Local Institution - 1058
Porto Alegre, Rio Grande do Sul 90430-001
Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul 90560-032
Brazil
Local Institution - 1057
Campinas, São Paulo 13060-080
Brazil
Local Institution - 1050
Rio de Janeiro, 22270-060
Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Brazil
Local Institution - 1056
São Paulo, 04020-060
Brazil
Local Institution - 1101
Pleven, 5800
Bulgaria
Local Institution - 1103
Razgrad, 7200
Bulgaria
Local Institution - 1100
Sofia, 1113
Bulgaria
Local Institution - 1104
Sofia, 1202
Bulgaria
Local Institution - 1102
Varna, 9020
Bulgaria
Local Institution - 1153
Hamilton, Ontario L8M 1W9
Canada
Local Institution - 1155
London, Ontario N6A 5A5
Canada
Local Institution - 1151
Toronto, Ontario M4N 3M5
Canada
Local Institution - 1154
Toronto, Ontario M6J 1H4
Canada
Local Institution - 1152
Whitby, Ontario L1N 5S9
Canada
Local Institution - 2051
Santiago, Santiago Metropolitan 7500710
Chile
Local Institution - 2052
Santiago, Santiago Metropolitan 8330024
Chile
Local Institution - 2054
Vitacura, Santiago Metropolitan 2511433
Chile
Local Institution - 2055
Viña del Mar, Valparaiso 2511433
Chile
Local Institution - 2053
Antofagasta, 1270244
Chile
Local Institution - 1805
Beijing, Beijing Municipality 100053
China
Local Institution - 1810
Beijing, Beijing Municipality 100088
China
Local Institution - 1815
Haidian District, Beijing Municipality 100191
China
Local Institution - 1809
Guangzhou, Guangdong 0
China
Local Institution - 1818
Shenzhen, Guangdong 518118
China
Local Institution - 1802
Guangzhou, Guangzhou Province 510260
China
Local Institution - 1803
Changsha, Hunan 410008
China
Local Institution - 1801
Nanjing, Jiangsu 210008
China
Local Institution - 1814
Tianjin, Tianjin Municipality 300074
China
Local Institution - 1804
Hangzhou, Zhejiang 310003
China
Local Institution - 1817
Hangzhou, Zhejiang 310016
China
Local Institution - 1812
Kunming, 650032
China
Local Institution - 1553
Zagreb, City of Zagreb 10000
Croatia
Local Institution - 1554
Rijeka, 51000
Croatia
Local Institution - 1551
Split, HR-21000
Croatia
Local Institution - 1552
Varaždin, 42000
Croatia
Local Institution - 1555
Zagreb, 10 090
Croatia
Local Institution - 1550
Zagreb, 10000
Croatia
Local Institution - 2107
Olomouc, Olomouc Region 779 00
Czechia
Local Institution - 2100
Prague, Praha 6 160 00
Czechia
Local Institution - 2106
Prague, Praha 8 18600
Czechia
Local Institution - 2103
Brno, South Moravian 628 00
Czechia
Local Institution - 2101
Choceň, 565 01
Czechia
Local Institution - 2104
Pilsen, 301 00
Czechia
Local Institution - 2102
Prague, 100 000
Czechia
Local Institution - 2105
Prague, 100 00
Czechia
Local Institution - 2108
Rychnov nad Kněžnou, 516 01
Czechia
Local Institution - 2150
Toulouse, Haute-Garonne 31000
France
Local Institution - 2151
Villeurbanne, Rhône 69100
France
Local Institution - 2153
Lille, 59037
France
Local Institution - 2156
Limoges, 87042
France
Local Institution - 2157
Montpellier, 34295
France
Local Institution - 2152
Paris, 75010
France
Local Institution - 2155
Strasbourg, 67091
France
Local Institution - 2201
Düsseldorf, 40221
Germany
Local Institution - 2205
Halle, 06120
Germany
Local Institution - 2206
Westerstede, 26655
Germany
Local Institution - 1200
Pátrai, Achaḯa 26504
Greece
Local Institution - 1205
Athens, Attica 115 26
Greece
Local Institution - 1202
Athens, Attica 11527
Greece
Local Institution - 1203
Chaïdári, Attikí 124 62
Greece
Local Institution - 0027
Athens, 106 79
Greece
Local Institution - 1206
Athens, 106 79
Greece
Local Institution - 1207
Athens, 15125
Greece
Local Institution - 1201
Ioannina, 45500
Greece
Local Institution - 1204
Thessaloniki, 54645
Greece
Local Institution - 2257
Kalocsa, Bács-Kiskun county 6300
Hungary
Local Institution - 2250
Győr, Győr-Moson-Sopron 0
Hungary
Local Institution - 2254
Gyöngyös, Heves County 3200
Hungary
Local Institution - 2255
Budapest, 1036
Hungary
Local Institution - 2251
Budapest, 1088
Hungary
Local Institution - 2253
Budapest, 1088
Hungary
Local Institution - 2252
Debrecen, 4032
Hungary
Local Institution - 1255
Ahmedabad, Gujarat 380060
India
Local Institution - 1252
Hyderabad, Telangana 500082
India
Local Institution - 1254
Varanasi, Uttar Pradesh 221005
India
Local Institution - 1250
Kolkata, West Bengal 700054
India
Local Institution - 1256
Delhi, 110 095
India
Local Institution - 1251
Hyderabad, 500034
India
Local Institution - 1253
New Delhi, 110029
India
Local Institution - 2302
Petch Tikva, IL 49100
Israel
Local Institution - 2303
Netanya, 4244916
Israel
Local Institution - 2305
Ramat Gan, 5262000
Israel
Local Institution - 2300
Ramat Gan, 5265601
Israel
Bayit Balev Ltd.
Rishon Le'Tzion, 7590653
Israel
Local Institution - 2351
Naples, Campania 80131
Italy
Local Institution - 2354
Rome, Lazio 00185
Italy
Local Institution - 2352
Rome, Lazio 00189
Italy
Auxologico IRCCS - Auxologico San Luca
Milan, Lombardy 20149
Italy
Local Institution - 2350
Pisa, PI 56126
Italy
Local Institution - 2356
Brescia, 25123
Italy
Local Institution - 2355
Isernia, 86077
Italy
Local Institution - 2357
Roma, 00168
Italy
Hatano Kousei Hospital
Hadano, Kanagawa 257-0003
Japan
Local Institution - 1307
Kawasaki, Kanagawa 213-8507
Japan
Asakayama Hospital
Sakai, Osaka 590-0018
Japan
National Hospital Organization Hizen Psychiatric Center
Kanzaki-Gun Yoshinogari-Cho, Saga-ken 842-0192
Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken 847-0031
Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo 113-8603
Japan
Kuramitsu Hospital
Fukuoka, 819-0037
Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, 700-8557
Japan
Local Institution - 1308
Shimotsuke-shi, Tochigi, 329-0498
Japan
Local Institution - 1355
Saltillo, Coahuila 25000
Mexico
Local Institution - 1356
Guadalajara, Jalisco 44600
Mexico
Local Institution - 1363
Mexico City, Mexico City 14090
Mexico
Local Institution - 1360
Mexico City, Mexico City 14269
Mexico
Local Institution - 1364
Monterrey, Nuevo León 64623
Mexico
Local Institution - 1350
Monterrey, Nuevo León 66460
Mexico
Local Institution - 1361
Mexico City, 10200
Mexico
Neurociencias PRISMA A.C.
San Luis Potosí City, 78216
Mexico
Local Institution - 1352
Tlalnepantla, 54055
Mexico
Local Institution - 2450
Poznan, Greater Poland Voivodeship 61-485
Poland
Local Institution - 2454
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-163
Poland
Local Institution - 2456
Chorzów, 41-500
Poland
Local Institution - 2455
Katowice, 40-146
Poland
Local Institution - 2458
Krakow, 31-505
Poland
Local Institution - 2451
Lublin, 20-064
Poland
Local Institution - 2452
Lublin, 20-064
Poland
Local Institution - 2453
Sochaczew, 96-500
Poland
Local Institution - 2457
Wroclaw, 53-659
Poland
Local Institution - 1401
Coimbra, 3049
Portugal
Local Institution - 1402
Guimarães, 4835-044
Portugal
Local Institution - 1404
Lisbon, 1649-035
Portugal
Local Institution - 1403
Senhora da Hora, 4464-513
Portugal
Local Institution - 1400
Torres Vedras, 2560-280
Portugal
Local Institution - 1450
Bucharest, Bucharest 041919
Romania
Local Institution - 1452
Bucharest, Bucharest 041919
Romania
Local Institution - 1453
Bucharest, Bucharest 041919
Romania
Local Institution - 1454
Bucharest, Bucharest 041919
Romania
Local Institution - 1455
Bucharest, Bucharest 041919
Romania
Local Institution - 1456
Bucharest, Bucharest 041919
Romania
Local Institution - 1458
Bucharest, Bucharest 041919
Romania
Local Institution - 1451
Bucharest, 010825
Romania
Local Institution - 1463
Bucharest, 011241
Romania
Local Institution - 1459
Bucharest, 060222
Romania
Local Institution - 1461
Constanța, 90123
Romania
Local Institution - 1457
Iași, 700282
Romania
Local Institution - 1460
Sanpetru /Brasov, 507190
Romania
Local Institution - 1464
Sibiu, 550052
Romania
Local Institution - 1462
Sibiu, 550082
Romania
Local Institution - 2401
Incheon, Incheon Gwang'yeogsi 22332
South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul] 03080
South Korea
Local Institution - 2403
Seoul, Seoul-teukbyeolsi [Seoul] 05030
South Korea
Local Institution - 2406
Seoul, Seoul-teukbyeolsi [Seoul] 06351
South Korea
Local Institution - 2400
Deagu, Taegu-Kwangyǒkshi 41404
South Korea
Local Institution - 2409
Incheon, 405-760
South Korea
Local Institution - 2402
Seoul, 05505
South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
South Korea
Local Institution - 2405
Seoul, 07061
South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345
South Korea
Local Institution - 1510
Getxo, Bizkaia 48993
Spain
Local Institution - 1509
Elche (alicante), 03203
Spain
Local Institution - 1508
Madrid, 28006
Spain
Hospital Clinico San Carlos
Madrid, 28040
Spain
Hospital Clinico Universitario Virgen de La Victoria
Málaga, 29010
Spain
Local Institution - 0003
Málaga, 29010
Spain
Local Institution - 1507
Pamplona, 31008
Spain
Local Institution - 1500
Salamanca, 37007
Spain
Local Institution - 1503
Seville, 41009
Spain
Hospital Mutua Terrassa
Terrassa, 8221
Spain
Hospital Universitario De Rio Hortega
Valladolid, 47012
Spain
Local Institution - 1501
Zaragoza, 50012
Spain
Local Institution - 1753
Kaohsiung Niao Sung Dist, Kaohsiung 83301
Taiwan
Local Institution - 1751
Tainan, Taiana, 704
Taiwan
Local Institution - 1754
Taipei, 100229
Taiwan
Taipei Veterans General Hospital
Taipei, 112
Taiwan
Local Institution - 1752
Taoyuan, 333
Taiwan
Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
Smila, Cherkasy Oblast 20708
Ukraine
Local Institution - 2554
Dnipro, Dnipropetrovsk Oblast 49115
Ukraine
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
Skarzhyntsi, Khmelnytskyi Oblast 32120
Ukraine
Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
Hlevakha, Kyiv Oblast 08631
Ukraine
Local Institution - 2552
Lviv, Lviv Oblast 79035
Ukraine
Local Institution - 2558
Lviv, Lviv Oblast 79035
Ukraine
Local Institution - 2569
Lviv, Lviv Oblast 79035
Ukraine
Local Institution - 2567
Oleksandrivka, Odesa Oblast 67513
Ukraine
Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"
Vinnytsia, Vinnytsia Oblast 21037
Ukraine
Local Institution - 2556
Hlevakha, 08631
Ukraine
Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
Kropyvnytskyi, 25491
Ukraine
Local Institution - 2565
Kyiv, 01030
Ukraine
Local Institution - 2553
Kyiv, 04080
Ukraine
Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
Poltava, 36013
Ukraine
Local Institution - 2562
Ternopil, 46027
Ukraine
Local Institution - 2505
Preston, Lancashire PR2 9HT
United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, Surrey KT16 9AU
United Kingdom
Local Institution - 2502
Cambridge, CB21 5EF
United Kingdom
Local Institution - 2501
London, SE5 8AZ
United Kingdom
Local Institution - 2500
London, W12 0NN
United Kingdom
NeuroClin Glasgow
Motherwell, ML1 4UF
United Kingdom
Cornwall Partnership NHS Foundation Trust
Redruth, TR15 3QE
United Kingdom
Local Institution - 2504
Sheffield, S5 7JT
United Kingdom
Local Institution - 2509
Stafford, ST16 3SR
United Kingdom
Local Institution - 2503
Wolverhampton, WV4 5HN
United Kingdom