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

June 1, 2026 updated by: Bristol-Myers Squibb

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

600

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
Phone Number: 855-907-3286
Email: Clinical.Trials@bms.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1199
    - Not yet recruiting
    - Local Institution - 2004
    - Contact:
      
      Site 2004
  - Buenos Aires, Argentina, C1428AQK
    - Not yet recruiting
    - Local Institution - 1003
    - Contact:
      
      Site 1003
  - Córdoba, Argentina, 5000
    - Not yet recruiting
    - Local Institution - 2002
    - Contact:
      
      Site 2002
  - Córdoba, Argentina, X5003DCE
    - Not yet recruiting
    - Local Institution - 2003
    - Contact:
      
      Site 2003
  - Córdoba, Argentina, 5000
    - Not yet recruiting
    - Local Institution - 1004
    - Contact:
      
      Site 1004
  - Córdoba, Argentina, 5000
    - Not yet recruiting
    - Local Institution - 2000
    - Contact:
      
      Site 2000
  - Córdoba, Argentina, 5004
    - Not yet recruiting
    - Local Institution - 1005
    - Contact:
      
      Site 1005
  - Córdoba, Argentina, 5006
    - Not yet recruiting
    - Local Institution - 1000
    - Contact:
      
      Site 1000
  - Mendoza, Argentina, 5502
    - Not yet recruiting
    - Local Institution - 2001
    - Contact:
      
      Site 2001
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1058
    - Not yet recruiting
    - Local Institution - 2005
    - Contact:
      
      Site 2005
  - La Plata, Buenos Aires, Argentina, 1900
    - Not yet recruiting
    - Local Institution - 1001
    - Contact:
      
      Site 1001
  - Mar del Plata, Buenos Aires, Argentina, B7602CBM
    - Not yet recruiting
    - Local Institution - 1002
    - Contact:
      
      Site 1002
- Buenos Aires F.D.
  - Buenos Aires, Buenos Aires F.D., Argentina, 1133
    - Not yet recruiting
    - Local Institution - 2006
    - Contact:
      
      Site 2006
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000
    - Not yet recruiting
    - Local Institution - 1006
    - Contact:
      
      Site 1006
Brazil
- - Rio de Janeiro, Brazil, 22270-060
    - Not yet recruiting
    - Local Institution - 1050
    - Contact:
      
      Site 1050
  - São Paulo, Brazil, 01228-000
    - Not yet recruiting
    - Local Institution - 1055
    - Contact:
      
      Site 1055
  - São Paulo, Brazil, 04020-060
    - Not yet recruiting
    - Local Institution - 1056
    - Contact:
      
      Site 1056
- Federal District
  - Brasília, Federal District, Brazil, 70200730
    - Not yet recruiting
    - Local Institution - 1051
    - Contact:
      
      Site 1051
- Paraná
  - Curitiba, Paraná, Brazil, 80240-280
    - Not yet recruiting
    - Local Institution - 1053
    - Contact:
      
      Site 1053
  - Curitiba, Paraná, Brazil, 80230-130
    - Not yet recruiting
    - Local Institution - 1052
    - Contact:
      
      Site 1052
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
    - Not yet recruiting
    - Local Institution - 1058
    - Contact:
      
      Site 1058
  - Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
    - Not yet recruiting
    - Local Institution - 1054
    - Contact:
      
      Site 1054
- São Paulo
  - Campinas, São Paulo, Brazil, 13060-080
    - Not yet recruiting
    - Local Institution - 1057
    - Contact:
      
      Site 1057
Bulgaria
- - Pleven, Bulgaria, 5800
    - Not yet recruiting
    - Local Institution - 1101
    - Contact:
      
      Site 1101
  - Razgrad, Bulgaria, 7200
    - Not yet recruiting
    - Local Institution - 1103
    - Contact:
      
      Site 1103
  - Varna, Bulgaria, 9020
    - Not yet recruiting
    - Local Institution - 1102
    - Contact:
      
      Site 1102
- Sofia-Grad
  - Sofia, Sofia-Grad, Bulgaria, 1113
    - Not yet recruiting
    - Local Institution - 1100
    - Contact:
      
      Site 1100
  - Sofia, Sofia-Grad, Bulgaria, 1202
    - Not yet recruiting
    - Local Institution - 1104
    - Contact:
      
      Site 1104
Canada
- Ontario
  - Hamilton, Ontario, Canada, ON L8M 1W9
    - Not yet recruiting
    - Local Institution - 1153
    - Contact:
      
      Site 1153
  - London, Ontario, Canada, N6A 5A5
    - Not yet recruiting
    - Local Institution - 1155
    - Contact:
      
      Site 1155
  - Toronto, Ontario, Canada, M4N 3M5
    - Not yet recruiting
    - Local Institution - 1151
    - Contact:
      
      Site 1151
  - Toronto, Ontario, Canada, M6J 1H4
    - Not yet recruiting
    - Local Institution - 1154
    - Contact:
      
      Site 1154
  - Whitby, Ontario, Canada, L1N 5S9
    - Not yet recruiting
    - Local Institution - 1152
    - Contact:
      
      Site 1152
Chile
- - Antofagasta, Chile, 1270244
    - Not yet recruiting
    - Local Institution - 2053
    - Contact:
      
      Site 2053
- Santiago Metropolitan
  - Santiago, Santiago Metropolitan, Chile, 7500710
    - Not yet recruiting
    - Local Institution - 2051
    - Contact:
      
      Site 2051
  - Santiago, Santiago Metropolitan, Chile, 8330024
    - Not yet recruiting
    - Local Institution - 2052
    - Contact:
      
      Site 2052
  - Vitacura, Santiago Metropolitan, Chile, 2511433
    - Not yet recruiting
    - Local Institution - 2054
    - Contact:
      
      Site 2054
- Valparaiso
  - Viña del Mar, Valparaiso, Chile, 2511433
    - Not yet recruiting
    - Local Institution - 2055
    - Contact:
      
      Site 2055
China
- - Kunming, China, 650032
    - Not yet recruiting
    - Local Institution - 1812
    - Contact:
      
      Site 1812
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100053
    - Not yet recruiting
    - Local Institution - 1805
    - Contact:
      
      Site 1805
  - Beijing, Beijing Municipality, China, 100088
    - Not yet recruiting
    - Local Institution - 1810
    - Contact:
      
      Site 1810
  - Haidian District, Beijing Municipality, China, 100191
    - Not yet recruiting
    - Local Institution - 1815
    - Contact:
      
      Site 1815
- Guangdong
  - Guangzhou, Guangdong, China
    - Not yet recruiting
    - Local Institution - 1809
    - Contact:
      
      Site 1809
  - Shenzhen, Guangdong, China, 518118
    - Not yet recruiting
    - Local Institution - 1818
    - Contact:
      
      Site 1818
- Guangzhou Province
  - Guangzhou, Guangzhou Province, China, 510260
    - Not yet recruiting
    - Local Institution - 1802
    - Contact:
      
      Site 1802
- Hunan
  - Changsha, Hunan, China, 410008
    - Not yet recruiting
    - Local Institution - 1803
    - Contact:
      
      Site 1803
- Jiangsu
  - Nanjing, Jiangsu, China, 210008
    - Not yet recruiting
    - Local Institution - 1801
    - Contact:
      
      Site 1801
- Tianjin Municipality
  - Tianjin, Tianjin Municipality, China, 300074
    - Not yet recruiting
    - Local Institution - 1814
    - Contact:
      
      Site 1814
- Zhejiang
  - Hangzhou, Zhejiang, China, 310003
    - Not yet recruiting
    - Local Institution - 1804
    - Contact:
      
      Site 1804
  - Hangzhou, Zhejiang, China, 310016
    - Not yet recruiting
    - Local Institution - 1817
    - Contact:
      
      Site 1817
Croatia
- - Rijeka, Croatia, 51000
    - Not yet recruiting
    - Local Institution - 1554
    - Contact:
      
      Site 1554
  - Split, Croatia, HR-21000
    - Not yet recruiting
    - Local Institution - 1551
    - Contact:
      
      Site 1551
  - Varaždin, Croatia, 42000
    - Not yet recruiting
    - Local Institution - 1552
    - Contact:
      
      Site 1552
  - Zagreb, Croatia, 10000
    - Not yet recruiting
    - Local Institution - 1550
    - Contact:
      
      Site 1550
- City of Zagreb
  - Zagreb, City of Zagreb, Croatia, 10000
    - Not yet recruiting
    - Local Institution - 1553
    - Contact:
      
      Site 1553
Czechia
- - Choceň, Czechia, 565 01
    - Not yet recruiting
    - Local Institution - 2101
    - Contact:
      
      Site 2101
  - Pilsen, Czechia, 301 00
    - Not yet recruiting
    - Local Institution - 2104
    - Contact:
      
      Site 2104
  - Prague, Czechia, 100 000
    - Withdrawn
    - Local Institution - 2102
  - Prague, Czechia, 100 00
    - Withdrawn
    - Local Institution - 2105
  - Rychnov nad Kněžnou, Czechia, 516 01
    - Not yet recruiting
    - Local Institution - 2108
    - Contact:
      
      Site 2108
- Olomouc Region
  - Olomouc, Olomouc Region, Czechia, 779 00
    - Not yet recruiting
    - Local Institution - 2107
    - Contact:
      
      Site 2107
- Praha 6
  - Prague, Praha 6, Czechia, 160 00
    - Not yet recruiting
    - Local Institution - 2100
    - Contact:
      
      Site 2100
- Praha 8
  - Prague, Praha 8, Czechia, 18600
    - Not yet recruiting
    - Local Institution - 2106
    - Contact:
      
      Site 2106
- South Moravian
  - Brno, South Moravian, Czechia, 628 00
    - Not yet recruiting
    - Local Institution - 2103
    - Contact:
      
      Site 2103
France
- - Lille, France, 59037
    - Not yet recruiting
    - Local Institution - 2153
    - Contact:
      
      Site 2153
  - Limoges, France, 87042
    - Not yet recruiting
    - Local Institution - 2156
    - Contact:
      
      Site 2156
  - Montpellier, France, 34295
    - Not yet recruiting
    - Local Institution - 2157
    - Contact:
      
      Site 2157
  - Paris, France, 75010
    - Not yet recruiting
    - Local Institution - 2152
    - Contact:
      
      Site 2152
  - Strasbourg, France, 67091
    - Not yet recruiting
    - Local Institution - 2155
    - Contact:
      
      Site 2155
- Haute-Garonne
  - Toulouse, Haute-Garonne, France, 31000
    - Not yet recruiting
    - Local Institution - 2150
    - Contact:
      
      Site 2150
- Rhône
  - Villeurbanne, Rhône, France, 69100
    - Not yet recruiting
    - Local Institution - 2151
    - Contact:
      
      Site 2151
Germany
- - Düsseldorf, Germany, 40221
    - Not yet recruiting
    - Local Institution - 2201
    - Contact:
      
      Site 2201
  - Halle, Germany, 06120
    - Not yet recruiting
    - Local Institution - 2205
    - Contact:
      
      Site 2205
  - Westerstede, Germany, 26655
    - Not yet recruiting
    - Local Institution - 2206
    - Contact:
      
      Site 2206
Greece
- - Athens, Greece, 106 79
    - Not yet recruiting
    - Local Institution - 1206
    - Contact:
      
      Site 1206
  - Athens, Greece, 15125
    - Not yet recruiting
    - Local Institution - 1207
    - Contact:
      
      Site 1207
  - Athens, Greece, 106 79
    - Withdrawn
    - Local Institution - 0027
  - Ioannina, Greece, 45500
    - Not yet recruiting
    - Local Institution - 1201
    - Contact:
      
      Site 1201
  - Thessaloniki, Greece, 54645
    - Not yet recruiting
    - Local Institution - 1204
    - Contact:
      
      Site 1204
- Achaḯa
  - Pátrai, Achaḯa, Greece, 26504
    - Not yet recruiting
    - Local Institution - 1200
    - Contact:
      
      Site 1200
- Attica
  - Athens, Attica, Greece, 115 26
    - Not yet recruiting
    - Local Institution - 1205
    - Contact:
      
      Site 1205
  - Athens, Attica, Greece, 11527
    - Not yet recruiting
    - Local Institution - 1202
    - Contact:
      
      Site 1202
- Attikí
  - Chaïdári, Attikí, Greece, 124 62
    - Not yet recruiting
    - Local Institution - 1203
    - Contact:
      
      Site 1203
Hungary
- - Budapest, Hungary, 1036
    - Not yet recruiting
    - Local Institution - 2255
    - Contact:
      
      Site 2255
  - Budapest, Hungary, 1088
    - Not yet recruiting
    - Local Institution - 2253
    - Contact:
      
      Site 2253
  - Budapest, Hungary, 1088
    - Withdrawn
    - Local Institution - 2251
  - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Local Institution - 2252
    - Contact:
      
      Site 2252
- Bács-Kiskun county
  - Kalocsa, Bács-Kiskun county, Hungary, 6300
    - Not yet recruiting
    - Local Institution - 2257
    - Contact:
      
      Site 2257
- Győr-Moson-Sopron
  - Győr, Győr-Moson-Sopron, Hungary
    - Not yet recruiting
    - Local Institution - 2250
    - Contact:
      
      Site 2250
- Heves County
  - Gyöngyös, Heves County, Hungary, 3200
    - Not yet recruiting
    - Local Institution - 2254
    - Contact:
      
      Site 2254
India
- - Delhi, India, 110 095
    - Not yet recruiting
    - Local Institution - 1256
    - Contact:
      
      Site 1256
  - Hyderabad, India, 500034
    - Not yet recruiting
    - Local Institution - 1251
    - Contact:
      
      Site 1251
  - New Delhi, India, 110029
    - Not yet recruiting
    - Local Institution - 1253
    - Contact:
      
      Site 1253
- Gujarat
  - Ahmedabad, Gujarat, India, 380060
    - Not yet recruiting
    - Local Institution - 1255
    - Contact:
      
      Site 1255
- Telangana
  - Hyderabad, Telangana, India, 500082
    - Not yet recruiting
    - Local Institution - 1252
    - Contact:
      
      Site 1252
- Uttar Pradesh
  - Varanasi, Uttar Pradesh, India, 221005
    - Not yet recruiting
    - Local Institution - 1254
    - Contact:
      
      Site 1254
- West Bengal
  - Kolkata, West Bengal, India, 700054
    - Not yet recruiting
    - Local Institution - 1250
    - Contact:
      
      Site 1250
Israel
- - Netanya, Israel, 4244916
    - Not yet recruiting
    - Local Institution - 2303
    - Contact:
      
      Site 2303
  - Ramat Gan, Israel, 5265601
    - Not yet recruiting
    - Local Institution - 2300
    - Contact:
      
      Site 2300
  - Ramat Gan, Israel, 5262000
    - Not yet recruiting
    - Local Institution - 2305
    - Contact:
      
      Site 2305
  - Rishon Le'Tzion, Israel, 7590653
    - Not yet recruiting
    - Local Institution - 2304
    - Contact:
      
      Site 2304
- IL
  - Petch Tikva, IL, Israel, 49100
    - Not yet recruiting
    - Local Institution - 2302
    - Contact:
      
      Site 2302
Italy
- - Brescia, Italy, 25123
    - Not yet recruiting
    - Local Institution - 2356
    - Contact:
      
      Site 2356
  - Isernia, Italy, 86077
    - Withdrawn
    - Local Institution - 2355
  - Roma, Italy, 00168
    - Not yet recruiting
    - Local Institution - 2357
    - Contact:
      
      Site 2357
- Campania
  - Naples, Campania, Italy, 80131
    - Not yet recruiting
    - Local Institution - 2351
    - Contact:
      
      Site 2351
- Lazio
  - Rome, Lazio, Italy, 00185
    - Not yet recruiting
    - Local Institution - 2354
    - Contact:
      
      Site 2354
  - Rome, Lazio, Italy, 00189
    - Not yet recruiting
    - Local Institution - 2352
    - Contact:
      
      Site 2352
- Lombardy
  - Milan, Lombardy, Italy, 20149
    - Not yet recruiting
    - Local Institution - 2353
    - Contact:
      
      Site 2353
- PI
  - Pisa, PI, Italy, 56126
    - Not yet recruiting
    - Local Institution - 2350
    - Contact:
      
      Site 2350
Japan
- - Fukuoka, Japan, 819-0037
    - Recruiting
    - Kuramitsu Hospital
    - Contact:
      
      Noriko Tamaru, Site 1302
      
      Phone Number: +81-92-811-1821
  - Okayama, Japan, 700-8557
    - Recruiting
    - Okayama City General Medical Center Okayama City Hospital
    - Contact:
      
      Kentaro Deguchi, Site 1306
  - Shimotsuke-shi, Tochigi, Japan, 329-0498
    - Not yet recruiting
    - Local Institution - 1308
    - Contact:
      
      Site 1308
- Kanagawa
  - Hadano, Kanagawa, Japan, 257-0003
    - Recruiting
    - Hatano Kousei Hospital
    - Contact:
      
      Sakai Yoshiro, Site 1301
  - Kawasaki, Kanagawa, Japan, 213-8507
    - Not yet recruiting
    - Local Institution - 1307
    - Contact:
      
      Site 1307
- Osaka
  - Sakai, Osaka, Japan, 590-0018
    - Recruiting
    - Asakayama Hospital
    - Contact:
      
      Kazue Kamae, Site 1304
      
      Phone Number: 0722294882
- Saga-ken
  - Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan, 842-0192
    - Recruiting
    - National Hospital Organization Hizen Psychiatric Center
    - Contact:
      
      Manabu Hashimoto, Site 1303
      
      Phone Number: 0952523231
  - Karatsu-shi, Saga-ken, Japan, 847-0031
    - Recruiting
    - Rainbow and Sea Hospital
    - Contact:
      
      Taro Shindo, Site 1300
      
      Phone Number: 0955770711
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8603
    - Recruiting
    - Nippon Medical School Hospital
    - Contact:
      
      Amane Tateno, Site 1305
Mexico
- - Mexico City, Mexico, 10200
    - Not yet recruiting
    - Local Institution - 1361
    - Contact:
      
      Site 1361
  - San Luis Potosí City, Mexico, 78216
    - Not yet recruiting
    - Local Institution - 1362
    - Contact:
      
      Site 1362
  - Tlalnepantla, Mexico, 54055
    - Not yet recruiting
    - Local Institution - 1352
    - Contact:
      
      Site 1352
- Coahuila
  - Saltillo, Coahuila, Mexico, 25000
    - Not yet recruiting
    - Local Institution - 1355
    - Contact:
      
      Site 1355
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44600
    - Not yet recruiting
    - Local Institution - 1356
    - Contact:
      
      Site 1356
- Mexico City
  - Mexico City, Mexico City, Mexico, 14090
    - Not yet recruiting
    - Local Institution - 1363
    - Contact:
      
      Site 1363
  - Mexico City, Mexico City, Mexico, 14269
    - Not yet recruiting
    - Local Institution - 1360
    - Contact:
      
      Site 1360
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 66460
    - Not yet recruiting
    - Local Institution - 1350
    - Contact:
      
      Site 1350
  - Monterrey, Nuevo León, Mexico, 64623
    - Not yet recruiting
    - Local Institution - 1364
    - Contact:
      
      Site 1364
Poland
- - Chorzów, Poland, 41-500
    - Not yet recruiting
    - Local Institution - 2456
    - Contact:
      
      Site 2456
  - Katowice, Poland, 40-146
    - Not yet recruiting
    - Local Institution - 2455
    - Contact:
      
      Site 2455
  - Lublin, Poland, 20-064
    - Withdrawn
    - Local Institution - 2452
  - Lublin, Poland, 20-064
    - Withdrawn
    - Local Institution - 2451
  - Sochaczew, Poland, 96-500
    - Not yet recruiting
    - Local Institution - 2453
    - Contact:
      
      Site 2453
  - Wroclaw, Poland, 53-659
    - Not yet recruiting
    - Local Institution - 2457
    - Contact:
      
      Site 2457
- Greater Poland Voivodeship
  - Poznan, Greater Poland Voivodeship, Poland, 61-485
    - Not yet recruiting
    - Local Institution - 2450
    - Contact:
      
      Site 2450
- Kuyavian-Pomeranian Voivodeship
  - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-163
    - Not yet recruiting
    - Local Institution - 2454
    - Contact:
      
      Site 2454
Portugal
- - Coimbra, Portugal, 3049
    - Not yet recruiting
    - Local Institution - 1401
    - Contact:
      
      Site 1401
  - Guimarães, Portugal, 4835-044
    - Not yet recruiting
    - Local Institution - 1402
    - Contact:
      
      Site 1402
  - Lisbon, Portugal, 1649-035
    - Not yet recruiting
    - Local Institution - 1404
    - Contact:
      
      Site 1404
  - Senhora da Hora, Portugal, 4464-513
    - Not yet recruiting
    - Local Institution - 1403
    - Contact:
      
      Site 1403
  - Torres Vedras, Portugal, 2560-280
    - Not yet recruiting
    - Local Institution - 1400
    - Contact:
      
      Site 1400
Romania
- - Bucharest, Romania, 010825
    - Not yet recruiting
    - Local Institution - 1451
    - Contact:
      
      Site 1451
  - Bucharest, Romania, 060222
    - Not yet recruiting
    - Local Institution - 1459
    - Contact:
      
      Site 1459
  - Constanța, Romania, 90123
    - Not yet recruiting
    - Local Institution - 1461
    - Contact:
      
      Site 1461
  - Iași, Romania, 700282
    - Not yet recruiting
    - Local Institution - 1457
    - Contact:
      
      Site 1457
  - Sanpetru /Brasov, Romania, 507190
    - Not yet recruiting
    - Local Institution - 1460
    - Contact:
      
      Site 1460
  - Sibiu, Romania, 550082
    - Not yet recruiting
    - Local Institution - 1462
    - Contact:
      
      Site 1462
- Bucharest
  - Bucharest, Bucharest, Romania, 041919
    - Not yet recruiting
    - Local Institution - 1450
    - Contact:
      
      Site 1450
  - Bucharest, Bucharest, Romania, 041919
    - Not yet recruiting
    - Local Institution - 1452
    - Contact:
      
      Site 1452
  - Bucharest, Bucharest, Romania, 041919
    - Not yet recruiting
    - Local Institution - 1453
    - Contact:
      
      Site 1453
  - Bucharest, Bucharest, Romania, 041919
    - Not yet recruiting
    - Local Institution - 1454
    - Contact:
      
      Site 1454
  - Bucharest, Bucharest, Romania, 041919
    - Not yet recruiting
    - Local Institution - 1455
    - Contact:
      
      Site 1455
  - Bucharest, Bucharest, Romania, 041919
    - Not yet recruiting
    - Local Institution - 1456
    - Contact:
      
      Site 1456
  - Bucharest, Bucharest, Romania, 041919
    - Not yet recruiting
    - Local Institution - 1458
    - Contact:
      
      Site 1458
South Korea
- - Incheon, South Korea, 405-760
    - Not yet recruiting
    - Local Institution - 2409
    - Contact:
      
      Site 2409
  - Seoul, South Korea, 05505
    - Not yet recruiting
    - Local Institution - 2402
    - Contact:
      
      Site 2402
  - Seoul, South Korea, 07061
    - Not yet recruiting
    - Local Institution - 2405
    - Contact:
      
      Site 2405
  - Seoul, South Korea, 06273
    - Recruiting
    - Gangnam Severance Hospital, Yonsei University Health System
    - Contact:
      
      Hanna Cho, Site 2408
  - Seoul, South Korea, 07345
    - Recruiting
    - The Catholic University of Korea, Yeouido St.Mary's Hospital
    - Contact:
      
      Hyun-Kook Lim, Site 2404
      
      Phone Number: 82216617575
- Incheon Gwang'yeogsi
  - Incheon, Incheon Gwang'yeogsi, South Korea, 22332
    - Not yet recruiting
    - Local Institution - 2401
    - Contact:
      
      Site 2401
- Seoul-teukbyeolsi [Seoul]
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05030
    - Not yet recruiting
    - Local Institution - 2403
    - Contact:
      
      Site 2403
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351
    - Withdrawn
    - Local Institution - 2406
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
    - Recruiting
    - Seoul National University Hospital
    - Contact:
      
      Manho Kim, Site 2407
      
      Phone Number: +82-2-2072-2193
- Taegu-Kwangyǒkshi
  - Deagu, Taegu-Kwangyǒkshi, South Korea, 41404
    - Not yet recruiting
    - Local Institution - 2400
    - Contact:
      
      Site 2400
Spain
- - Elche (alicante), Spain, 03203
    - Not yet recruiting
    - Local Institution - 1509
    - Contact:
      
      Site 1509
  - Madrid, Spain, 28006
    - Not yet recruiting
    - Local Institution - 1508
    - Contact:
      
      Site 1508
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Local Institution - 1505
    - Contact:
      
      Site 1505
  - Málaga, Spain, 29010
    - Not yet recruiting
    - Local Institution - 1502
    - Contact:
      
      Site 1502
  - Málaga, Spain, 29010
    - Withdrawn
    - Local Institution - 0003
  - Pamplona, Spain, 31008
    - Not yet recruiting
    - Local Institution - 1507
    - Contact:
      
      Site 1507
  - Salamanca, Spain, 37007
    - Not yet recruiting
    - Local Institution - 1500
    - Contact:
      
      Site 1500
  - Seville, Spain, 41009
    - Not yet recruiting
    - Local Institution - 1503
    - Contact:
      
      Site 1503
  - Terrassa, Spain, 8221
    - Not yet recruiting
    - Local Institution - 1504
    - Contact:
      
      Site 1504
  - Valladolid, Spain, 47012
    - Not yet recruiting
    - Local Institution - 1506
    - Contact:
      
      Site 1506
  - Zaragoza, Spain, 50012
    - Not yet recruiting
    - Local Institution - 1501
    - Contact:
      
      Site 1501
- Bizkaia
  - Getxo, Bizkaia, Spain, 48993
    - Not yet recruiting
    - Local Institution - 1510
    - Contact:
      
      Site 1510
Taiwan
- - Tainan, Taiana, Taiwan, 704
    - Not yet recruiting
    - Local Institution - 1751
    - Contact:
      
      Site 1751
  - Taipei, Taiwan, 100229
    - Not yet recruiting
    - Local Institution - 1754
    - Contact:
      
      Site 1754
  - Taipei, Taiwan, 112
    - Not yet recruiting
    - Local Institution - 1750
    - Contact:
      
      Site 1750
  - Taoyuan, Taiwan, 333
    - Not yet recruiting
    - Local Institution - 1752
    - Contact:
      
      Site 1752
- Kaohsiung
  - Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
    - Not yet recruiting
    - Local Institution - 1753
    - Contact:
      
      Site 1753
Ukraine
- - Hlevakha, Ukraine, 08631
    - Not yet recruiting
    - Local Institution - 2556
    - Contact:
      
      Site 2556
  - Kropyvnytskyi, Ukraine, 25491
    - Not yet recruiting
    - Local Institution - 2550
    - Contact:
      
      Site 2550
  - Kyiv, Ukraine, 01030
    - Not yet recruiting
    - Local Institution - 2565
    - Contact:
      
      Site 2565
  - Kyiv, Ukraine, 04080
    - Not yet recruiting
    - Local Institution - 2553
    - Contact:
      
      Site 2553
  - Odesa, Ukraine, 65006
    - Not yet recruiting
    - Local Institution - 2568
    - Contact:
      
      Site 2568
  - Poltava, Ukraine, 36013
    - Not yet recruiting
    - Local Institution - 2557
    - Contact:
      
      Site 2557
- Cherkasy Oblast
  - Smila, Cherkasy Oblast, Ukraine, 20708
    - Not yet recruiting
    - Local Institution - 2555
    - Contact:
      
      Site 2555
- Dnipropetrovsk Oblast
  - Dnipro, Dnipropetrovsk Oblast, Ukraine, 49115
    - Not yet recruiting
    - Local Institution - 2554
    - Contact:
      
      Site 2554
- Khmelnytskyi Oblast
  - Skarzhyntsi, Khmelnytskyi Oblast, Ukraine, 32120
    - Not yet recruiting
    - Local Institution - 2559
    - Contact:
      
      Site 2559
- Kyiv Oblast
  - Hlevakha, Kyiv Oblast, Ukraine, 08631
    - Not yet recruiting
    - Local Institution - 2566
    - Contact:
      
      Site 2566
- Lviv Oblast
  - Lviv, Lviv Oblast, Ukraine, 79035
    - Not yet recruiting
    - Local Institution - 2558
    - Contact:
      
      Site 2558
  - Lviv, Lviv Oblast, Ukraine, 79035
    - Not yet recruiting
    - Local Institution - 2569
    - Contact:
      
      Site 2569
  - Lviv, Lviv Oblast, Ukraine, 79035
    - Not yet recruiting
    - Local Institution - 2552
    - Contact:
      
      Site 2552
- Odesa Oblast
  - Oleksandrivka, Odesa Oblast, Ukraine, 67513
    - Not yet recruiting
    - Local Institution - 2567
    - Contact:
      
      Site 2567
- Ternopil Oblast
  - Ternopil, Ternopil Oblast, Ukraine, 460027
    - Not yet recruiting
    - Local Institution - 2562
    - Contact:
      
      Site 2562
- Vinnytsia Oblast
  - Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
    - Not yet recruiting
    - Local Institution - 2551
    - Contact:
      
      Site 2551
United Kingdom
- - Cambridge, United Kingdom, CB21 5EF
    - Not yet recruiting
    - Local Institution - 2502
    - Contact:
      
      Site 2502
  - London, United Kingdom, SE5 8AZ
    - Not yet recruiting
    - Local Institution - 2501
    - Contact:
      
      Site 2501
  - London, United Kingdom, W12 0NN
    - Not yet recruiting
    - Local Institution - 2500
    - Contact:
      
      Site 2500
  - Motherwell, United Kingdom, ML1 4UF
    - Recruiting
    - NeuroClin Glasgow
    - Contact:
      
      Jennifer Lynch, Site 2510
      
      Phone Number: +44 141 948 0206
  - Redruth, United Kingdom, TR15 3QE
    - Recruiting
    - Cornwall Partnership NHS Foundation Trust
    - Contact:
      
      Nicholas Jacobsen, Site 2507
      
      Phone Number: +44 1208 251 300
  - Sheffield, United Kingdom, S5 7JT
    - Not yet recruiting
    - Local Institution - 2504
    - Contact:
      
      Site 2504
  - Stafford, United Kingdom, ST16 3SR
    - Withdrawn
    - Local Institution - 2509
  - Wolverhampton, United Kingdom, WV4 5HN
    - Not yet recruiting
    - Local Institution - 2503
    - Contact:
      
      Site 2503
- Lancashire
  - Preston, Lancashire, United Kingdom, PR2 9HT
    - Not yet recruiting
    - Local Institution - 2505
    - Contact:
      
      Site 2505
- Surrey
  - Chertsey, Surrey, United Kingdom, KT16 9AU
    - Recruiting
    - Surrey and Borders Partnership NHS Foundation Trust
    - Contact:
      
      Ramin Nilforooshan, Site 2508
      
      Phone Number: +44 300 555 5222
United States
- Arizona
  - Chandler, Arizona, United States, 85224
    - Not yet recruiting
    - Local Institution - 2609
    - Contact:
      
      Site 2609
  - Scottsdale, Arizona, United States, 85258
    - Recruiting
    - Imaging Endpoints
    - Contact:
      
      Nida Laurin, Site 1619
      
      Phone Number: 480-290-1547
- California
  - Anaheim, California, United States, 92805
    - Not yet recruiting
    - Local Institution - 1657
    - Contact:
      
      Site 1657
  - Canoga Park, California, United States, 91303
    - Not yet recruiting
    - Local Institution - 2620
    - Contact:
      
      Site 2620
  - La Jolla, California, United States, 92037
    - Not yet recruiting
    - Local Institution - 1637
    - Contact:
      
      Site 1637
  - Long Beach, California, United States, 90040
    - Not yet recruiting
    - Local Institution - 2625
    - Contact:
      
      Site 2625
  - Long Beach, California, United States, 90805
    - Not yet recruiting
    - Local Institution - 2607
    - Contact:
      
      Site 2607
  - Long Beach, California, United States, 90807
    - Not yet recruiting
    - Local Institution - 2642
    - Contact:
      
      Site 2642
  - Pasadena, California, United States, 91105
    - Not yet recruiting
    - Local Institution - 2613
    - Contact:
      
      Site 2613
  - Pomona, California, United States, 91767
    - Not yet recruiting
    - Local Institution - 1662
    - Contact:
      
      Site 1662
  - Torrance, California, United States, 90505
    - Not yet recruiting
    - Local Institution - 1639
    - Contact:
      
      Site 1639
  - Walnut Creek, California, United States, 94596
    - Not yet recruiting
    - Local Institution - 1651
    - Contact:
      
      Site 1651
- Florida
  - Bonita Springs, Florida, United States, 34134-4154
    - Not yet recruiting
    - Local Institution - 2602
    - Contact:
      
      Site 2602
  - Hialeah, Florida, United States, 33012
    - Not yet recruiting
    - Local Institution - 2626
    - Contact:
      
      Site 2626
  - Miami, Florida, United States, 33186
    - Recruiting
    - Nuovida Research Center
    - Contact:
      
      Jorge Betancourt, MD, Site 1604
      
      Phone Number: 786-616-9853
  - Miami, Florida, United States, 33135
    - Not yet recruiting
    - Local Institution - 1618
    - Contact:
      
      Site 1618
  - Miami, Florida, United States, 33122
    - Not yet recruiting
    - Local Institution - 1602
    - Contact:
      
      Site 1602
  - Orlando, Florida, United States, 32807
    - Not yet recruiting
    - Local Institution - 1635
    - Contact:
      
      Site 1635
  - Port Orange, Florida, United States, 32127
    - Recruiting
    - Progressive Medical Research
    - Contact:
      
      Alexander White, Site 1612
      
      Phone Number: 386-304-7070
  - Tampa, Florida, United States, 33629
    - Recruiting
    - IPTB Clinical Research
    - Contact:
      
      Jamie Fernandez, Site 2621
      
      Phone Number: 813-251-1800
  - Virginia Gardens, Florida, United States, 33166
    - Recruiting
    - Hope Research Network - Miami
    - Contact:
      
      Jorge Jorge, Site 1609
      
      Phone Number: 786-681-4959
- Georgia
  - Atlanta, Georgia, United States, 30328
    - Not yet recruiting
    - Local Institution - 2611
    - Contact:
      
      Site 2611
- Maryland
  - Gaithersburg, Maryland, United States, 20877
    - Not yet recruiting
    - Local Institution - 1636
    - Contact:
      
      Site 1636
- Massachusetts
  - Newton, Massachusetts, United States, 02459
    - Recruiting
    - Boston Center for Memory
    - Contact:
      
      Paul Solomon, Site 1638
      
      Phone Number: 413-281-0577
  - Worcester, Massachusetts, United States, 01608
    - Not yet recruiting
    - Local Institution - 2615
    - Contact:
      
      Site 2615
- Michigan
  - Ann Arbor, Michigan, United States, 48105
    - Not yet recruiting
    - Local Institution - 2618
    - Contact:
      
      Site 2618
  - Troy, Michigan, United States, 48085
    - Not yet recruiting
    - Local Institution - 1620
    - Contact:
      
      Site 1620
- Minnesota
  - Saint Paul, Minnesota, United States, 55130
    - Not yet recruiting
    - Local Institution - 2256
    - Contact:
      
      Site 2256
- Mississippi
  - Hattiesburg, Mississippi, United States, 39402
    - Not yet recruiting
    - Local Institution - 2629
    - Contact:
      
      Site 2629
- Nevada
  - Las Vegas, Nevada, United States, 89119
    - Recruiting
    - Redbird Research
    - Contact:
      
      Jelena Kunovac, Site 1649
      
      Phone Number: 760-758-2222
  - Las Vegas, Nevada, United States, 89030
    - Not yet recruiting
    - Local Institution - 2628
    - Contact:
      
      Site 2628
- New Jersey
  - West Long Branch, New Jersey, United States, 07764
    - Not yet recruiting
    - Local Institution - 1647
    - Contact:
      
      Site 1647
- New York
  - New Windsor, New York, United States, 12553
    - Not yet recruiting
    - Local Institution - 1656
    - Contact:
      
      Site 1656
  - Staten Island, New York, United States, 10312
    - Not yet recruiting
    - Local Institution - 2619
    - Contact:
      
      Site 2619
  - Woodmere, New York, United States, 11598-1739
    - Not yet recruiting
    - Local Institution - 1658
    - Contact:
      
      Site 1658
- North Carolina
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - West Clinical Research
    - Contact:
      
      Patrick Morgante, Site 2608
      
      Phone Number: 252-515-0050
- Ohio
  - Blue Ash, Ohio, United States, 45242
    - Not yet recruiting
    - Local Institution - 2617
    - Contact:
      
      Site 2617
- Oklahoma
  - Tulsa, Oklahoma, United States, 74136
    - Not yet recruiting
    - Local Institution - 1640
    - Contact:
      
      Site 1640
- Texas
  - Carrollton, Texas, United States, 75006
    - Recruiting
    - Epic Medical Research, LLC - Carrolton
    - Contact:
      
      Andrea Brown, Site 2616
      
      Phone Number: 972-782-2405
  - Cypress, Texas, United States, 77065
    - Not yet recruiting
    - Local Institution - 2605
    - Contact:
      
      Site 2605
  - El Paso, Texas, United States, 79912
    - Not yet recruiting
    - Local Institution - 1643
    - Contact:
      
      Site 1643
  - Mesquite, Texas, United States, 75150
    - Not yet recruiting
    - Local Institution - 2622
    - Contact:
      
      Site 2622
  - San Antonio, Texas, United States, 78229
    - Not yet recruiting
    - Local Institution - 2623
    - Contact:
      
      Site 2623
- Utah
  - Bountiful, Utah, United States, 84010
    - Recruiting
    - Pantheon Clinical Research, LLC
    - Contact:
      
      Jackson Rhudy, Site 2612
      
      Phone Number: 801-200-3950
- Vermont
  - Bennington, Vermont, United States, 05201-9810
    - Not yet recruiting
    - Local Institution - 1646
    - Contact:
      
      Site 1646
- Washington
  - Seattle, Washington, United States, 98122
    - Not yet recruiting
    - Local Institution - 1644
    - Contact:
      
      Site 1644
  - Spokane, Washington, United States, 99201
    - Not yet recruiting
    - Local Institution - 1654
    - Contact:
      
      Site 1654
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Not yet recruiting
    - Local Institution - 2610
    - Contact:
      
      Site 2610

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Participants must have completed study CN012-0023 or CN012-0024 per protocol.
Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KarXT+KarX-EC	Drug: KarXT Specified dose on specified days Other Names: Xanomeline and Trospium Chloride capsule, BMS-986510 Drug: KarX-EC Specified dose on specified days Other Names: Xanomeline enteric capsules, BMS-986519

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) Time Frame: Up to approximately Week 30	Up to approximately Week 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) Time Frame: Up to approximately Week 30		Up to approximately Week 30
Number of Participants With Serious AEs (SAEs) Time Frame: Up to approximately Week 30		Up to approximately Week 30
Number of Participants With TEAEs Leading to Study Withdrawal Time Frame: Up to approximately Week 30		Up to approximately Week 30
Number of Participants With TEAEs Leading to Death Time Frame: Up to approximately Week 30		Up to approximately Week 30
Number of Participants with Adverse Events of Special Interest (AESI) Time Frame: Up to approximately Week 30		Up to approximately Week 30
Change From Baseline in Barnes Akathisia Rating Scale (BARS) Time Frame: Up to approximately Week 26		Up to approximately Week 26
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Time Frame: Up to approximately Week 26		Up to approximately Week 26
Change From Baseline in Body Weight Time Frame: Up to approximately Week 26		Up to approximately Week 26
Change From Baseline in Body Mass Index (BMI) Time Frame: Up to approximately Week 26		Up to approximately Week 26
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Heart Rate (HR) Time Frame: Up to approximately Week 30	This includes measuring of HR, both supine and standing or seated and upon standing after 2 minutes.	Up to approximately Week 30
Number of Participants With Clinically Significant Changes in Orthostatic Vital Sign: Blood Pressure (BP) Time Frame: Up to approximately Week 30	This includes measuring of systolic and diastolic BP, both supine and standing or seated and upon standing after 2 minutes.	Up to approximately Week 30
Number of Participants With Clinically Significant Changes in Laboratory Evaluations Time Frame: Up to approximately Week 30		Up to approximately Week 30
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Time Frame: Up to approximately Week 26		Up to approximately Week 26
Number of Participants With Suicidal Ideations as Assessed Using the Columbia-Suicide Severity Rating Scale (C-SSRS) Time Frame: Up to approximately Week 30		Up to approximately Week 30
Number of Participants With Cognitive Impairment as Assessed by Mini-mental State Examination (MMSE) Time Frame: Up to approximately Week 26		Up to approximately Week 26
Number of Participants With Cognitive Impairment as Assessed by 13-item Variation of ADAS-Cog Scale (ADAS-Cog-13) Time Frame: Up to approximately Week 26		Up to approximately Week 26
Change From Baseline in the Severity of Benign Prostatic Hyperplasia as Assessed by International Prostate Symptom Score (IPSS) Time Frame: Up to approximately Week 26	This analysis is done in male participants.	Up to approximately Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2025

Primary Completion (Estimated)

June 22, 2029

Study Completion (Estimated)

July 20, 2029

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 15, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CN012-0025
2024-519994-20 (Other Identifier: EU CTR)
U1111-1316-3903 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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