Alzheimer DiseasePhase 3NCT06937229

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

A Phase 3 study testing KarXT and KarX-EC in people with Alzheimer Disease and Agitation, run by Bristol-Myers Squibb at 252 sites in 26 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent… Read more about this study

Who is it for?: Ages 55 to 90 years
Conditions the study is for: Alzheimer Disease, Agitation
What is being tested?: KarXT and KarX-EC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 650 participants
Where: 252 sitesin 26 countries
Study dates: 2 Dec 2025to 20 Jul 2029
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

252 sites in 26 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com contact

855-907-3286

Clinical.Trials@bms.com

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

Country

City, postcode or hospital

Sites recruiting now only

252 sites in 26 countries

United States42 sites, 41 recruiting

Local Institution - 1657
Anaheim, California, 92805
Site 1657
Not yet recruiting
Local Institution - 2611
Atlanta, Georgia, 30328
Site 2611
Not yet recruiting
Local Institution - 1646
Bennington, Vermont, 05201-9810
Site 1646
Not yet recruiting
Local Institution - 2617
Blue Ash, Ohio, 45242
Site 2617
Not yet recruiting
Local Institution - 2602
Bonita Springs, Florida, 34134-4154
Site 2602
Not yet recruiting
Local Institution - 2612
Bountiful, Utah, 84010
Completed
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, 75006
Andrea Brown, Site 2616, 972-782-2405
Recruiting
Local Institution - 2609
Chandler, Arizona, 85224
Site 2609
Not yet recruiting
Horizon Clinical Research Center - Houston
Cypress, Texas, 77429
Harpaul Gill, Site 2605, 949-491-0710
Recruiting
Advanced Neurology Epilepsy and Sleep Center
El Paso, Texas, 79902
Aamr Herekar, Site 1643, 505-903-1715
Recruiting
Local Institution - 1668
Fresno, California, 93710
Site 1668
Not yet recruiting
Local Institution - 1636
Gaithersburg, Maryland, 20877
Site 1636
Not yet recruiting
Local Institution - 2629
Hattiesburg, Mississippi, 39402
Site 2629
Not yet recruiting
Local Institution - 2628
Las Vegas, Nevada, 89030
Site 2628
Not yet recruiting
Redbird Research
Las Vegas, Nevada, 89119
Jelena Kunovac, Site 1649, 760-758-2222
Recruiting
Local Institution - 2625
Long Beach, California, 90040
Site 2625
Not yet recruiting
Local Institution - 2642
Long Beach, California, 90807
Site 2642
Not yet recruiting
Local Institution - 2622
Mesquite, Texas, 75150
Site 2622
Not yet recruiting
Nuovida Research Center
Miami, Florida, 33186
Jorge Betancourt, MD, Site 1604, 786-616-9853
Recruiting
Local Institution - 2610
Milwaukee, Wisconsin, 53226
Site 2610
Not yet recruiting
West Clinical Research
Morehead City, North Carolina, 28557
Patrick Morgante, Site 2608, 252-515-0050
Recruiting
Local Institution - 1656
New Windsor, New York, 12553
Site 1656
Not yet recruiting
Boston Center for Memory
Newton, Massachusetts, 02459
Paul Solomon, Site 1638, 413-281-0577
Recruiting
Local Institution - 2649
Orange, California, 92866
Site 2649
Not yet recruiting
Local Institution - 1635
Orlando, Florida, 32807
Site 1635
Not yet recruiting
Local Institution - 2613
Pasadena, California, 91105
Site 2613
Not yet recruiting
Local Institution - 1662
Pomona, California, 91767
Site 1662
Not yet recruiting
Progressive Medical Research
Port Orange, Florida, 32127
Alexander White, Site 1612, 386-304-7070
Recruiting
Local Institution - 1664
Princeton, New Jersey, 08540
Site 1664
Not yet recruiting
Local Institution - 2256
Saint Paul, Minnesota, 55130
Site 2256
Not yet recruiting
Local Institution - 2623
San Antonio, Texas, 78229
Site 2623
Not yet recruiting
Imaging Endpoints
Scottsdale, Arizona, 85258
Nida Laurin, Site 1619, 480-290-1547
Recruiting
Local Institution - 1644
Seattle, Washington, 98122
Site 1644
Not yet recruiting
Local Institution - 2619
Staten Island, New York, 10312
Site 2619
Not yet recruiting
IPTB Clinical Research
Tampa, Florida, 33629
Jamie Fernandez, Site 2621, 813-251-1800
Recruiting
Local Institution - 1639
Torrance, California, 90505
Site 1639
Not yet recruiting
Local Institution - 1620
Troy, Michigan, 48085
Site 1620
Not yet recruiting
Local Institution - 1640
Tulsa, Oklahoma, 74136
Site 1640
Not yet recruiting
Hope Research Network - Miami
Virginia Gardens, Florida, 33166
Jorge Jorge, Site 1609, 786-681-4959
Recruiting
Local Institution - 1651
Walnut Creek, California, 94596
Site 1651
Not yet recruiting
Local Institution - 1658
Woodmere, New York, 11598-1739
Site 1658
Not yet recruiting
Local Institution - 2615
Worcester, Massachusetts, 01608
Site 2615
Not yet recruiting

Other trials in United States

Romania15 sites, 13 recruiting

Local Institution - 1450
Bucharest, Bucharest, 041919
Site 1450
Not yet recruiting
Local Institution - 1452
Bucharest, Bucharest, 041919
Site 1452
Not yet recruiting
Local Institution - 1453
Bucharest, Bucharest, 041919
Site 1453
Not yet recruiting
Local Institution - 1454
Bucharest, Bucharest, 041919
Site 1454
Not yet recruiting
Local Institution - 1455
Bucharest, Bucharest, 041919
Site 1455
Not yet recruiting
Local Institution - 1456
Bucharest, Bucharest, 041919
Site 1456
Not yet recruiting
Local Institution - 1458
Bucharest, Bucharest, 041919
Site 1458
Not yet recruiting
Local Institution - 1451
Bucharest, 010825
Withdrawn
Local Institution - 1463
Bucharest, 011241
Site 1463
Not yet recruiting
Local Institution - 1459
Bucharest, 060222
Withdrawn
Local Institution - 1461
Constanța, 90123
Site 1461
Not yet recruiting
Local Institution - 1457
Iași, 700282
Site 1457
Not yet recruiting
Local Institution - 1460
Sanpetru /Brasov, 507190
Site 1460
Not yet recruiting
Local Institution - 1464
Sibiu, 550052
Site 1464
Not yet recruiting
Local Institution - 1462
Sibiu, 550082
Site 1462
Not yet recruiting

Other trials in Romania

Ukraine15 sites, 15 recruiting

MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
Dnipro, Dnipropetrovsk Oblast, 49115
Svitlana Moroz, Site 2554, +380675658914
Recruiting
Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
Hlevakha, Kyiv Oblast, 08631
Gennadii Zilberblat, Site 2566, 380506480750
Recruiting
Local Institution - 2556
Hlevakha, 08631
Site 2556
Not yet recruiting
Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
Kropyvnytskyi, 25491
Yevhen Denysov, Site 2550, +380505641035
Recruiting
Local Institution - 2565
Kyiv, 01030
Site 2565
Not yet recruiting
Local Institution - 2553
Kyiv, 04080
Site 2553
Not yet recruiting
COMMUNAL NONCOMMERCIAL ENTERPRISE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
Lviv, Lviv Oblast, 79021
Yuriy Filts, Site 2552, +380-67-6702827
Recruiting
Local Institution - 2558
Lviv, Lviv Oblast, 79035
Site 2558
Not yet recruiting
Local Institution - 2569
Lviv, Lviv Oblast, 79035
Site 2569
Not yet recruiting
Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
Oleksandrivka, Odesa Oblast, 67513
Yevgen Oprya, Site 2567, +380679920420
Recruiting
Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
Poltava, 36013
Andriy Skrypnikov, Site 2557, +380502523300
Recruiting
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
Skarzhyntsi, Khmelnytskyi Oblast, 32120
Viktoriia Kachynska, Site 2559, 380672624158
Recruiting
Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
Smila, Cherkasy Oblast, 20708
Iryna Kosenkova, Site 2555, 380473321979
Recruiting
Local Institution - 2562
Ternopil, 46027
Site 2562
Not yet recruiting
Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"
Vinnytsia, Vinnytsia Oblast, 21037
Oksana Serebrennikova, Site 2551, +380679605672
Recruiting

Other trials in Ukraine

Argentina14 sites, 14 recruiting

Local Institution - 2006
Buenos Aires, Buenos Aires F.D., 1133
Site 2006
Not yet recruiting
Local Institution - 2004
Buenos Aires, 1199
Site 2004
Not yet recruiting
Local Institution - 1003
Buenos Aires, C1428AQK
Site 1003
Not yet recruiting
Local Institution - 2005
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1058
Site 2005
Not yet recruiting
Local Institution - 1004
Córdoba, 5000
Site 1004
Not yet recruiting
Local Institution - 2000
Córdoba, 5000
Site 2000
Not yet recruiting
Local Institution - 2002
Córdoba, 5000
Site 2002
Not yet recruiting
Local Institution - 1005
Córdoba, 5004
Site 1005
Not yet recruiting
Local Institution - 1000
Córdoba, 5006
Site 1000
Not yet recruiting
Local Institution - 2003
Córdoba, X5003DCE
Site 2003
Not yet recruiting
Local Institution - 1001
La Plata, Buenos Aires, 1900
Site 1001
Not yet recruiting
Local Institution - 1002
Mar del Plata, Buenos Aires, B7602CBM
Site 1002
Not yet recruiting
Local Institution - 2001
Mendoza, 5502
Site 2001
Not yet recruiting
Local Institution - 1006
Rosario, Santa Fe Province, S2000
Site 1006
Not yet recruiting

Other trials in Argentina

China12 sites, 12 recruiting

Local Institution - 1805
Beijing, Beijing Municipality, 100053
Site 1805
Not yet recruiting
Local Institution - 1810
Beijing, Beijing Municipality, 100088
Site 1810
Not yet recruiting
Local Institution - 1803
Changsha, Hunan, 410008
Site 1803
Not yet recruiting
Local Institution - 1809
Guangzhou, Guangdong, 0
Site 1809
Not yet recruiting
Local Institution - 1802
Guangzhou, Guangzhou Province, 510260
Site 1802
Not yet recruiting
Local Institution - 1815
Haidian District, Beijing Municipality, 100191
Site 1815
Not yet recruiting
Local Institution - 1804
Hangzhou, Zhejiang, 310003
Site 1804
Not yet recruiting
Local Institution - 1817
Hangzhou, Zhejiang, 310016
Site 1817
Not yet recruiting
Local Institution - 1812
Kunming, 650032
Site 1812
Not yet recruiting
Nanjing Drum Tower hospital
Nanjing, Jiangsu, 210008
Yun Xu, Site 1801
Recruiting
Local Institution - 1818
Shenzhen, Guangdong, 518118
Site 1818
Not yet recruiting
Local Institution - 1814
Tianjin, Tianjin Municipality, 300074
Site 1814
Not yet recruiting

Other trials in China

Spain12 sites, 11 recruiting

Local Institution - 1509
Elche (alicante), 03203
Site 1509
Not yet recruiting
Oroitu CAE
Getxo, Bizkaia, 48993
Manuel Fernandez, Site 1510, +34 946 559 219
Recruiting
Local Institution - 1508
Madrid, 28006
Site 1508
Not yet recruiting
Hospital Clinico San Carlos
Madrid, 28040
Jordi Matias Guiu, Site 1505
Recruiting
Hospital Clinico Universitario Virgen de La Victoria
Málaga, 29010
Carlos De La Cruz Cosme, Site 1502, 675 486 977
Recruiting
Local Institution - 0003
Málaga, 29010
Withdrawn
Local Institution - 1507
Pamplona, 31008
Site 1507
Not yet recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Angel Luis Montejo, Site 1500, +34639754620
Recruiting
Local Institution - 1503
Seville, 41009
Site 1503
Not yet recruiting
Hospital Mutua Terrassa
Terrassa, 8221
Jerzy Krupinski, Site 1504, +34937365050ext13939
Recruiting
Hospital Universitario De Rio Hortega
Valladolid, 47012
Juan Muñoz Sanchez, Site 1506, +34679279973
Recruiting
Local Institution - 1501
Zaragoza, 50012
Site 1501
Not yet recruiting

Other trials in Spain

South Korea10 sites, 9 recruiting

Local Institution - 2400
Deagu, Taegu-Kwangyǒkshi, 41404
Site 2400
Not yet recruiting
Inha University Hospital
Incheon, Incheon Gwang'yeogsi, 22332
Seong Hye Choi, Site 2401, +82328902080
Recruiting
Local Institution - 2409
Incheon, 405-760
Site 2409
Not yet recruiting
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080
Manho Kim, Site 2407, +82-2-2072-2193
Recruiting
Local Institution - 2403
Seoul, Seoul-teukbyeolsi [Seoul], 05030
Site 2403
Not yet recruiting
Local Institution - 2406
Seoul, Seoul-teukbyeolsi [Seoul], 06351
Withdrawn
Local Institution - 2402
Seoul, 05505
Site 2402
Not yet recruiting
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Hanna Cho, Site 2408
Recruiting
Local Institution - 2405
Seoul, 07061
Site 2405
Not yet recruiting
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345
Hyun-Kook Lim, Site 2404, 82216617575
Recruiting

Other trials in South Korea

United Kingdom10 sites, 9 recruiting

Local Institution - 2502
Cambridge, CB21 5EF
Site 2502
Not yet recruiting
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, Surrey, KT16 9AU
Ramin Nilforooshan, Site 2508, +44 300 555 5222
Recruiting
Local Institution - 2501
London, SE5 8AZ
Site 2501
Not yet recruiting
Local Institution - 2500
London, W12 0NN
Site 2500
Not yet recruiting
NeuroClin Glasgow
Motherwell, ML1 4UF
Jennifer Lynch, Site 2510, +44 141 948 0206
Recruiting
Local Institution - 2505
Preston, Lancashire, PR2 9HT
Site 2505
Not yet recruiting
Cornwall Partnership NHS Foundation Trust
Redruth, TR15 3QE
Nicholas Jacobsen, Site 2507, +44 1208 251 300
Recruiting
Local Institution - 2504
Sheffield, S5 7JT
Site 2504
Not yet recruiting
Local Institution - 2509
Stafford, ST16 3SR
Withdrawn
Local Institution - 2503
Wolverhampton, WV4 5HN
Site 2503
Not yet recruiting

Other trials in United Kingdom

Brazil9 sites, 9 recruiting

Local Institution - 1051
Brasília, Federal District, 70200730
Site 1051
Not yet recruiting
Local Institution - 1057
Campinas, São Paulo, 13060-080
Site 1057
Not yet recruiting
Local Institution - 1052
Curitiba, Paraná, 80230-130
Site 1052
Not yet recruiting
Local Institution - 1053
Curitiba, Paraná, 80240-280
Site 1053
Not yet recruiting
Local Institution - 1058
Porto Alegre, Rio Grande do Sul, 90430-001
Site 1058
Not yet recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-032
Wyllians Borelli, Site 1054, 5551991019123
Recruiting
Local Institution - 1050
Rio de Janeiro, 22270-060
Site 1050
Not yet recruiting
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Leonel Takada, Site 1055, 5511971539018
Recruiting
Local Institution - 1056
São Paulo, 04020-060
Site 1056
Not yet recruiting

Other trials in Brazil

Czechia9 sites, 7 recruiting

Neuro Health Centrum s.r.o.
Brno, South Moravian, 628 00
Katerina Sheardova, Site 2103, +420603198029
Recruiting
Local Institution - 2101
Choceň, 565 01
Site 2101
Not yet recruiting
AGE Centrum
Olomouc, Olomouc Region, 779 00
Dagmar Malotova, Site 2107, 00420723060809
Recruiting
Local Institution - 2104
Pilsen, 301 00
Site 2104
Not yet recruiting
Local Institution - 2100
Prague, Praha 6, 160 00
Site 2100
Not yet recruiting
Local Institution - 2106
Prague, Praha 8, 18600
Site 2106
Not yet recruiting
Local Institution - 2102
Prague, 100 000
Withdrawn
Local Institution - 2105
Prague, 100 00
Withdrawn
Local Institution - 2108
Rychnov nad Kněžnou, 516 01
Site 2108
Not yet recruiting

Other trials in Czechia

Greece9 sites, 8 recruiting

Local Institution - 1205
Athens, Attica, 115 26
Site 1205
Not yet recruiting
Local Institution - 1202
Athens, Attica, 11527
Site 1202
Not yet recruiting
Local Institution - 0027
Athens, 106 79
Withdrawn
Local Institution - 1206
Athens, 106 79
Site 1206
Not yet recruiting
Local Institution - 1207
Athens, 15125
Site 1207
Not yet recruiting
Local Institution - 1203
Chaïdári, Attikí, 124 62
Site 1203
Not yet recruiting
Local Institution - 1201
Ioannina, 45500
Site 1201
Not yet recruiting
Local Institution - 1200
Pátrai, Achaḯa, 26504
Site 1200
Not yet recruiting
Local Institution - 1204
Thessaloniki, 54645
Site 1204
Not yet recruiting

Other trials in Greece

Japan9 sites, 9 recruiting

Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
Amane Tateno, Site 1305
Recruiting
Kuramitsu Hospital
Fukuoka, 819-0037
Noriko Tamaru, Site 1302, +81-92-811-1821
Recruiting
Hatano Kousei Hospital
Hadano, Kanagawa, 257-0003
Sakai Yoshiro, Site 1301
Recruiting
National Hospital Organization Hizen Psychiatric Center
Kanzaki-Gun Yoshinogari-Cho, Saga-ken, 842-0192
Manabu Hashimoto, Site 1303, 0952523231
Recruiting
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, 847-0031
Taro Shindo, Site 1300, 0955770711
Recruiting
Local Institution - 1307
Kawasaki, Kanagawa, 213-8507
Site 1307
Not yet recruiting
Okayama City General Medical Center Okayama City Hospital
Okayama, 700-8557
Kentaro Deguchi, Site 1306
Recruiting
Asakayama Hospital
Sakai, Osaka, 590-0018
Kazue Kamae, Site 1304, 0722294882
Recruiting
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498
Shiro Suda, Site 1308, 81285442111
Recruiting

Other trials in Japan

Mexico9 sites, 9 recruiting

Boca Clinical Trials Mexico S.C.
Guadalajara, Jalisco, 44600
Hector Cruz, Site 1356, 3316546308
Recruiting
Local Institution - 1363
Mexico City, Mexico City, 14090
Site 1363
Not yet recruiting
Local Institution - 1360
Mexico City, Mexico City, 14269
Site 1360
Not yet recruiting
Local Institution - 1361
Mexico City, 10200
Site 1361
Not yet recruiting
AVIX Investigacion Clinica
Monterrey, Nuevo León, 64623
Amador Macias, Site 1364, 5218182528996
Recruiting
Local Institution - 1350
Monterrey, Nuevo León, 66460
Site 1350
Not yet recruiting
Local Institution - 1355
Saltillo, Coahuila, 25000
Site 1355
Not yet recruiting
Neurociencias PRISMA A.C.
San Luis Potosí City, 78216
Carlos Guerra Galicia, Site 1362
Recruiting
Local Institution - 1352
Tlalnepantla, 54055
Site 1352
Not yet recruiting

Other trials in Mexico

Poland9 sites, 6 recruiting

Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163
Pawel Lisewski, Site 2454, 0048698619497
Recruiting
Local Institution - 2456
Chorzów, 41-500
Site 2456
Not yet recruiting
Local Institution - 2455
Katowice, 40-146
Withdrawn
Local Institution - 2458
Krakow, 31-505
Site 2458
Not yet recruiting
Local Institution - 2451
Lublin, 20-064
Withdrawn
Local Institution - 2452
Lublin, 20-064
Withdrawn
Local Institution - 2450
Poznan, Greater Poland Voivodeship, 61-485
Site 2450
Not yet recruiting
RCMed Oddzial Sochaczew
Sochaczew, 96-500
Małgorzata Fengler-Czeczko, Site 2453, +48 697 777 777
Recruiting
Local Institution - 2457
Wroclaw, 53-659
Site 2457
Not yet recruiting

Other trials in Poland

Italy8 sites, 7 recruiting

Local Institution - 2356
Brescia, 25123
Site 2356
Not yet recruiting
Local Institution - 2355
Isernia, 86077
Withdrawn
Auxologico IRCCS - Auxologico San Luca
Milan, Lombardy, 20149
Nicola Ticozzi, Site 2353, 3902619112937
Recruiting
Local Institution - 2351
Naples, Campania, 80131
Site 2351
Not yet recruiting
Local Institution - 2350
Pisa, PI, 56126
Site 2350
Not yet recruiting
Local Institution - 2357
Roma, 00168
Site 2357
Not yet recruiting
Local Institution - 2354
Rome, Lazio, 00185
Site 2354
Not yet recruiting
Local Institution - 2352
Rome, Lazio, 00189
Site 2352
Not yet recruiting

Other trials in Italy

France7 sites, 7 recruiting

Local Institution - 2153
Lille, 59037
Site 2153
Not yet recruiting
Local Institution - 2156
Limoges, 87042
Site 2156
Not yet recruiting
Local Institution - 2157
Montpellier, 34295
Site 2157
Not yet recruiting
Local Institution - 2152
Paris, 75010
Site 2152
Not yet recruiting
Local Institution - 2155
Strasbourg, 67091
Site 2155
Not yet recruiting
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne, 31000
Maria Eugenia Soto-Martin, Site 2150
Recruiting
Local Institution - 2151
Villeurbanne, Rhône, 69100
Site 2151
Not yet recruiting

Other trials in France

Hungary7 sites, 3 recruiting

Local Institution - 2255
Budapest, 1036
Site 2255
Not yet recruiting
Local Institution - 2251
Budapest, 1088
Withdrawn
Local Institution - 2253
Budapest, 1088
Site 2253
Not yet recruiting
Local Institution - 2252
Debrecen, 4032
Site 2252
Not yet recruiting
Local Institution - 2254
Gyöngyös, 3200
Withdrawn
Local Institution - 2250
Győr, Győr-Moson-Sopron, 0
Withdrawn
Local Institution - 2257
Kalocsa, Bács-Kiskun county, 6300
Withdrawn

Other trials in Hungary

India7 sites, 7 recruiting

Local Institution - 1255
Ahmedabad, Gujarat, 380060
Site 1255
Not yet recruiting
Local Institution - 1256
Delhi, 110 095
Site 1256
Not yet recruiting
Local Institution - 1252
Hyderabad, Telangana, 500082
Site 1252
Not yet recruiting
Local Institution - 1251
Hyderabad, 500034
Site 1251
Not yet recruiting
Local Institution - 1250
Kolkata, West Bengal, 700054
Site 1250
Not yet recruiting
Local Institution - 1253
New Delhi, 110029
Site 1253
Not yet recruiting
Local Institution - 1254
Varanasi, Uttar Pradesh, 221005
Site 1254
Not yet recruiting

Other trials in India

Croatia6 sites, 6 recruiting

Local Institution - 1554
Rijeka, 51000
Site 1554
Not yet recruiting
Local Institution - 1551
Split, HR-21000
Site 1551
Not yet recruiting
Local Institution - 1552
Varaždin, 42000
Site 1552
Not yet recruiting
Local Institution - 1553
Zagreb, City of Zagreb, 10000
Site 1553
Not yet recruiting
Local Institution - 1555
Zagreb, 10 090
Site 1555
Not yet recruiting
Local Institution - 1550
Zagreb, 10000
Site 1550
Not yet recruiting

Other trials in Croatia

Bulgaria5 sites, 5 recruiting

Local Institution - 1101
Pleven, 5800
Site 1101
Not yet recruiting
Local Institution - 1103
Razgrad, 7200
Site 1103
Not yet recruiting
Medical Center Sveti Naum EOOD
Sofia, 1113
Assen Karadaliev, Site 1100, 35929702117
Recruiting
Local Institution - 1104
Sofia, 1202
Site 1104
Not yet recruiting
Local Institution - 1102
Varna, 9020
Site 1102
Not yet recruiting

Other trials in Bulgaria

Canada5 sites, 5 recruiting

Local Institution - 1153
Hamilton, Ontario, L8M 1W9
Site 1153
Not yet recruiting
Local Institution - 1155
London, Ontario, N6A 5A5
Site 1155
Not yet recruiting
Local Institution - 1151
Toronto, Ontario, M4N 3M5
Site 1151
Not yet recruiting
Local Institution - 1154
Toronto, Ontario, M6J 1H4
Site 1154
Not yet recruiting
Ontario Shores Centre For Mental Health Sciences
Whitby, Ontario, L1N 5S9
Amer Burhan, Site 1152, 905-430-4055 x6268
Recruiting

Other trials in Canada

Chile5 sites, 5 recruiting

Local Institution - 2053
Antofagasta, 1270244
Site 2053
Not yet recruiting
Local Institution - 2051
Santiago, Santiago Metropolitan, 7500710
Site 2051
Not yet recruiting
Local Institution - 2052
Santiago, Santiago Metropolitan, 8330024
Site 2052
Not yet recruiting
Local Institution - 2055
Viña del Mar, Valparaiso, 2511433
Site 2055
Not yet recruiting
Local Institution - 2054
Vitacura, Santiago Metropolitan, 2511433
Site 2054
Not yet recruiting

Other trials in Chile

Israel5 sites, 5 recruiting

Sanz MC, Laniado Hospital
Netanya, 4244916
Vered Hermush, Site 2303
Recruiting
Local Institution - 2302
Petch Tikva, IL, 49100
Site 2302
Not yet recruiting
Local Institution - 2305
Ramat Gan, 5262000
Site 2305
Not yet recruiting
Local Institution - 2300
Ramat Gan, 5265601
Site 2300
Not yet recruiting
Bayit Balev Ltd.
Rishon Le'Tzion, 7590653
Gisele Sasson, Site 2304
Recruiting

Other trials in Israel

Portugal5 sites, 5 recruiting

Local Institution - 1401
Coimbra, 3049
Site 1401
Not yet recruiting
Local Institution - 1402
Guimarães, 4835-044
Site 1402
Not yet recruiting
Local Institution - 1404
Lisbon, 1649-035
Site 1404
Not yet recruiting
Local Institution - 1403
Senhora da Hora, 4464-513
Site 1403
Not yet recruiting
Local Institution - 1400
Torres Vedras, 2560-280
Site 1400
Not yet recruiting

Other trials in Portugal

Taiwan5 sites, 5 recruiting

Local Institution - 1753
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Site 1753
Not yet recruiting
Local Institution - 1751
Tainan, Taiana, 704
Site 1751
Not yet recruiting
Local Institution - 1754
Taipei, 100229
Site 1754
Not yet recruiting
Taipei Veterans General Hospital
Taipei, 112
Jong-Ling Fuh, Site 1750
Recruiting
Local Institution - 1752
Taoyuan, 333
Site 1752
Not yet recruiting

Other trials in Taiwan

Germany3 sites, 3 recruiting

Local Institution - 2201
Düsseldorf, 40221
Site 2201
Not yet recruiting
Local Institution - 2205
Halle, 06120
Site 2205
Not yet recruiting
Local Institution - 2206
Westerstede, 26655
Site 2206
Not yet recruiting

Other trials in Germany

About this study

Official title: A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)

Conditions: Alzheimer Disease, Agitation
Being tested: KarXT, KarX-EC
Keywords: Agitation, Alzheimer disease, KarXT, KarX-EC
Medical subject headings: Alzheimer Disease, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KarXTDrug
Also called Xanomeline and Trospium Chloride capsule, BMS-986510
Specified dose on specified days
KarX-ECDrug
Also called Xanomeline enteric capsules, BMS-986519
Specified dose on specified days

Study groups in NCT06937229
Study group	Role	What they receive
KarXT+KarX-EC	Experimental	Not described Receives: Drug: KarXT; Drug: KarX-EC

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to approximately Week 30

Secondary outcomes (17)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 202520 Jul 2029

First posted22 Apr 2025
Study start2 Dec 2025
Primary completion22 Jun 2029 (estimated)
Study completion20 Jul 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 650 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06937229
Sponsor's protocol ID: CN012-0025
Other IDs: 2024-519994-20, U1111-1316-3903
Status last verified: Oct 2026
First submitted: 15 Apr 2025
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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