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

August 18, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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
        • Recruiting
        • CPQuali Pesquisa Clínica
        • Contact:
          • Leonel Takada, Site 1055
          • Phone Number: 5511971539018
      • 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
        • Recruiting
        • Hospital Moinhos de Vento
        • Contact:
          • Wyllians Borelli, Site 1054
          • Phone Number: 5551991019123
    • 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
      • Sofia, Bulgaria, 1202
        • Not yet recruiting
        • Local Institution - 1104
        • Contact:
          • Site 1104
      • Sofia, Bulgaria, 1113
        • Not yet recruiting
        • Local Institution - 1100
        • Contact:
          • Site 1100
      • Varna, Bulgaria, 9020
        • Not yet recruiting
        • Local Institution - 1102
        • Contact:
          • Site 1102
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, 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
        • Recruiting
        • Ontario Shores Centre For Mental Health Sciences
        • Contact:
          • Amer Burhan, Site 1152
          • Phone Number: 905-430-4055 x6268
  • 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
      • Zagreb, Croatia, 10 090
        • Not yet recruiting
        • Local Institution - 1555
        • Contact:
          • Site 1555
    • 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
        • Withdrawn
        • Local Institution - 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
        • Recruiting
        • Sanz MC, Laniado Hospital
        • Contact:
          • Vered Hermush, 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
        • Recruiting
        • Bayit Balev Ltd.
        • Contact:
          • Gisele Sasson, 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
        • Recruiting
        • Auxologico IRCCS - Auxologico San Luca
        • Contact:
          • Nicola Ticozzi, Site 2353
          • Phone Number: +39 3928537305
    • 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
        • Recruiting
        • Neurociencias PRISMA A.C.
        • Contact:
          • Carlos Guerra Galicia, 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
        • Recruiting
        • Avix Investigacion Clinica
        • Contact:
          • Amador Macias, Site 1364
          • Phone Number: 5218182528996
  • 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
      • Krakow, Poland, 31-505
        • Not yet recruiting
        • Local Institution - 2458
        • Contact:
          • Site 2458
      • Lublin, Poland, 20-064
        • Withdrawn
        • Local Institution - 2452
      • Lublin, Poland, 20-064
        • Withdrawn
        • Local Institution - 2451
      • Sochaczew, Poland, 96-500
        • Recruiting
        • RCMed Oddzial Sochaczew
        • Contact:
          • Małgorzata Fengler-Czeczko, Site 2453
          • Phone Number: +48 697 777 777
      • 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
      • Bucharest, Romania, 011241
        • Not yet recruiting
        • Local Institution - 1463
        • Contact:
          • Site 1463
      • 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
      • Sibiu, Romania, 550052
        • Not yet recruiting
        • Local Institution - 1464
        • Contact:
          • Site 1464
    • 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, 28040
        • Recruiting
        • Hospital Clinico San Carlos
        • Contact:
          • Jordi Matias Guiu, Site 1505
      • Madrid, Spain, 28006
        • Not yet recruiting
        • Local Institution - 1508
        • Contact:
          • Site 1508
      • Málaga, Spain, 29010
        • Recruiting
        • Hospital Clinico Universitario Virgen de la Victoria
        • Contact:
          • Carlos De La Cruz Cosme, Site 1502
          • Phone Number: 675 486 977
      • Málaga, Spain, 29010
        • Withdrawn
        • Local Institution - 0003
      • Pamplona, Spain, 31008
        • Not yet recruiting
        • Local Institution - 1507
        • Contact:
          • Site 1507
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
        • Contact:
          • Angel Luis Montejo, Site 1500
          • Phone Number: +34639754620
      • Seville, Spain, 41009
        • Not yet recruiting
        • Local Institution - 1503
        • Contact:
          • Site 1503
      • Terrassa, Spain, 8221
        • Recruiting
        • Hospital Mutua Terrassa
        • Contact:
          • Jerzy Krupinski, Site 1504
          • Phone Number: +34937365050ext13939
      • Valladolid, Spain, 47012
        • Recruiting
        • Hospital Universitario De Rio Hortega
        • Contact:
          • Juan Muñoz Sanchez, Site 1506
          • Phone Number: +34679279973
      • Zaragoza, Spain, 50012
        • Not yet recruiting
        • Local Institution - 1501
        • Contact:
          • Site 1501
    • Bizkaia
      • Getxo, Bizkaia, Spain, 48993
        • Recruiting
        • Oroitu CAE
        • Contact:
          • Manuel Fernandez, Site 1510
          • Phone Number: +34 946 559 219
  • Taiwan
      • Tainan, Taiana, Taiwan, 704
        • Not yet recruiting
        • Local Institution - 1751
        • Contact:
          • Site 1751
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
          • Jong-Ling Fuh, Site 1750
      • Taipei, Taiwan, 100229
        • Not yet recruiting
        • Local Institution - 1754
        • Contact:
          • Site 1754
      • 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
        • Recruiting
        • Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
        • Contact:
          • Yevgen Denysov, Site 2550
          • Phone Number: +380505641035
      • Kyiv, Ukraine, 01030
        • Not yet recruiting
        • Local Institution - 2565
        • Contact:
          • Site 2565
      • Kyiv, Ukraine, 04080
        • Not yet recruiting
        • Local Institution - 2553
        • Contact:
          • Site 2553
      • Poltava, Ukraine, 36013
        • Recruiting
        • Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
        • Contact:
          • Andriy Skrypnikov, Site 2557
          • Phone Number: +380502523300
      • Ternopil, Ukraine, 46027
        • Not yet recruiting
        • Local Institution - 2562
        • Contact:
          • Site 2562
    • Cherkasy Oblast
      • Smila, Cherkasy Oblast, Ukraine, 20708
        • Recruiting
        • Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
        • Contact:
          • Iryna Kosenkova, Site 2555
          • Phone Number: 380473321979
    • Dnipropetrovsk Oblast
      • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49115
        • Recruiting
        • MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
        • Contact:
          • Svitlana Moroz, Site 2554
          • Phone Number: +380675658914
    • Khmelnytskyi Oblast
      • Skarzhyntsi, Khmelnytskyi Oblast, Ukraine, 32120
        • Recruiting
        • Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
        • Contact:
          • Viktoriia Kachynska, Site 2559
          • Phone Number: 380672624158
    • Kyiv Oblast
      • Hlevakha, Kyiv Oblast, Ukraine, 08631
        • Recruiting
        • Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
        • Contact:
          • Gennadii Zilberblat, Site 2566
          • Phone Number: 380506480750
    • 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, 79021
        • Recruiting
        • COMMUNAL NONCOMMERCIAL ENTERPRISE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
        • Contact:
          • Yuriy Filts, Site 2552
          • Phone Number: +380-67-6702827
    • Odesa Oblast
      • Oleksandrivka, Odesa Oblast, Ukraine, 67513
        • Not yet recruiting
        • Local Institution - 2567
        • Contact:
          • Site 2567
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
        • Recruiting
        • Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"
        • Contact:
          • Oksana Serebrennikova, Site 2551
          • Phone Number: +380679605672
  • 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
      • 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, 90807
        • Not yet recruiting
        • Local Institution - 2642
        • Contact:
          • Site 2642
      • Orange, California, United States, 92866
        • Not yet recruiting
        • Local Institution - 2649
        • Contact:
          • Site 2649
      • 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
      • 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
      • Princeton, New Jersey, United States, 08540
        • Not yet recruiting
        • Local Institution - 1664
        • Contact:
          • Site 1664
    • 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, 77429
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have completed study CN012-0023 or CN012-0024 per protocol.
  • Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).

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)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

No

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