Psychosis Associated With Alzheimer's DiseasePhase 3NCT05980949
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
A Phase 3 study testing KarXT in people with Psychosis Associated With Alzheimer's Disease, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 432 sites in 31 countries.
Trial summary
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to… Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Psychosis Associated With Alzheimer's Disease
- What is being tested?
- KarXT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 432 sitesin 31 countries
- Study dates
- 11 Jul 2023to 7 Sep 2027
- 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
- Must have completed study KAR-031 (CN012-0026), KAR-032(CN012-0027), or CN012-0056. This Inclusion criterion is not applicable for Protocol Amendment 07 or later versions.
- Can understand the nature of the study and protocol requirements and provide a signed informed consent (IC) form before any study assessments are performed. If the subject is deemed not competent to provide IC, both the following requirements for consent must be met:
- The subject's legally acceptable representative (LAR) must provide IC
- The subject must provide informed assent
- Must have stable living environment. At entry into this study, or any time during the study, if a subject needs to relocate from home, a residential assisted-living facility, or other stable location to a nursing home facility, the Sponsor/Medical Monitor must approve the subject's participation in the study.
Who cannot join
- Significant or severe medical conditions that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results.
- Clinically significant abnormalities, including any finding(s) from the ECG, laboratory tests, physical examination, or vital signs, at the EOT visit of Study KAR-031 (Visit 19), Study KAR-032 (Visit 12), Study CN012-0056 (Visit 12) that the Investigator, in consultation with the Medical Monitor, are considered to jeopardize the safety of the subject.
- Subjects participating in another investigational drug or device study or planning on participating in another clinical study during the duration of KAR-033.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
432 sites in 31 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
432 sites in 31 countries
United States148 sites, 87 recruiting
- Recruiting
Advanced Research Center, Inc.
Anaheim, California, 92805-5854
Steven Macina, Site 1104, 714-999-6688
- Not yet recruiting
Local Institution - 1241
Arlington, Virginia, 22205
Site 1241
- Recruiting
Agile Clinical Research Trials, LLC
Atlanta, Georgia, 30328-5532
Vasundhara Cheekati, Site 1206, 404-382-8660
- Withdrawn
Local Institution - 1225
Atlantis, Florida, 33462
- Not yet recruiting
Local Institution - 1223
Belmont, Massachusetts, 02478-1064
Site 1223
- Withdrawn
Local Institution - 1037
Berwyn, Illinois, 60402-2173
- Withdrawn
Local Institution - 1-146Y4PVY
Bloomfield Township, Michigan, 48302-1909
- Not yet recruiting
Local Institution - 1248
Bloomfield Township, Michigan, 48302-1909
Site 1248
- Withdrawn
Local Institution - 1011
Boca Raton, Florida, 33487-2768
- Recruiting
Envision Trials LLC
Bonita Springs, Florida, 34134
Daniel Mandri, Site 1020, 305-819-2909
- Not yet recruiting
Local Institution - 1245
Boston, Massachusetts, 02111-1552
Site 1245
- Withdrawn
Local Institution - 1015
Bradenton, Florida, 34209-4687
- Withdrawn
Local Institution - 1-13H98LK9
Chandler, Arizona, 85224-6231
- Withdrawn
Local Institution - 1227
Chandler, Arizona, 85224
- Withdrawn
Local Institution - 1116
Chandler, Arizona, 85286
- Withdrawn
Local Institution - 1035
Charleston, South Carolina, 29425-8900
- Not yet recruiting
Local Institution - 1-141NO1DG
Chino, California, 91710
Site 1-141NO1DG
- Not yet recruiting
Local Institution - 1244
Chino, California, 91710
Site 1244
- Withdrawn
Local Institution - 1156
Clermont, Florida, 34711-5190
- Recruiting
K2 Medical Research - Winter Garden
Clermont, Florida, 34711-5933
Christopher Galloway, Site 1048, 321-500-5252
- Withdrawn
Local Institution - 1014
Colorado Springs, Colorado, 80907-5302
- Not yet recruiting
Local Institution - 1201
Columbus, Ohio, 43210
Site 1201
- Withdrawn
Local Institution - 1001
Costa Mesa, California, 92626
- Recruiting
JY Research Institute Inc
Cutler Bay, Florida, 33189-1230
Suez Oramas Mingo, Site 1138, 305-424-8696
- Recruiting
Horizon Clinical Research: Gill Neuroscience
Cypress, Texas, 77429-6070
Harpaul Gill, Site 1106, 949-491-0710
- Withdrawn
Local Institution - 1122
Dayton, Ohio, 45459-4248
- Recruiting
Arrow Clinical Trials
Daytona Beach, Florida, 32117-5532
David Billmeier, Site 1023, 386-278-8000
- Withdrawn
Local Institution - 1161
Decatur, Georgia, 30030
- Withdrawn
Local Institution - 1224
Deerfield Beach, Florida, 33442
- Withdrawn
Local Institution - 1162
Delray Beach, Florida, 33445-2581
- Not yet recruiting
Local Institution - 1121
DeSoto, Texas, 75115-2043
Site 1121
- Recruiting
Integrity Clinical Research LLC - 21st Street
Doral, Florida, 33122-1620
Lucinda Cuervo-Ramos, Site 1164, 305-888-0410
- Recruiting
Betancourt Research Services
Doral, Florida, 33172-2638
Beatriz Triana, Site 1045, 786-741-2287
- Not yet recruiting
Local Institution - 1208
El Paso, Texas, 79912-1743
Site 1208
- Withdrawn
Local Institution - 1148
Elgin, Illinois, 60123-9215
- Withdrawn
Local Institution - 1151
Encino, California, 91316
- Withdrawn
Local Institution - 1033
Encino, California, 91436-2201
- Recruiting
University of Connecticut Health Center
Farmington, Connecticut, 06030
Neha Jain, Site 1222, 860-790-7354
- Withdrawn
Local Institution - 1022
Flower Mound, Texas, 75028-2011
- Recruiting
Precise Research Centers
Flowood, Mississippi, 39232
Joseph Kwentus, Site 1132, 601-420-5810
- Withdrawn
Local Institution - 1165
Fort Myers, Florida, 33912-4302
- Withdrawn
Local Institution - 1036
Frisco, Texas, 75034-6262
- Not yet recruiting
Local Institution - 1247
Gilbert, Arizona, 85297
Site 1247
- Not yet recruiting
Local Institution - 1221
Greensboro, North Carolina, 27410-3311
Site 1221
- Completed
Local Institution - 1155
Hialeah, Florida, 33012-3158
- Recruiting
Direct Helpers Research Center
Hialeah, Florida, 33012-3618
Manuel Fernandez, Site 1107, 305-828-3555
- Recruiting
New Life Medical Research Center -3750 W 16th Ave
Hialeah, Florida, 33012-4648
Jorge Betancourt, Site 1120, 305-456-7782
- Not yet recruiting
Local Institution - 1046
Hialeah, Florida, 33012-5826
Site 1046
- Recruiting
Las Mercedes Medical Research - 4440 West 16th Ave
Hialeah, Florida, 33012
Frank Carlos Alvarez Li, Site 1052, 786-334-6675
- Withdrawn
Local Institution - 1-13JED81K
Hialeah, Florida, 33013
- Withdrawn
Local Institution - 1237
Hialeah, Florida, 33013
- Recruiting
Galiz Research
Hialeah, Florida, 33016-1814
Jose Gamez, Site 1140, 305-805-0921
- Recruiting
Nexus Clinical Research Center- NRC
Homestead, Florida, 33030
John Cintron, Site 1229
- Withdrawn
Local Institution - 1145
Homestead, Florida, 33032-8187
- Recruiting
Coral Clinic Research
Homestead, Florida, 33032
Nelson Gonzalez, Site 1049, 786-715-2200
- Recruiting
Homestead Associates in Research Inc-30328 Old Dixie Hwy
Homestead, Florida, 33033
Angel Carrasco, Site 1159, 786-422-7374
- Withdrawn
Local Institution - 1029
Homewood, Alabama, 35209-6809
- Recruiting
Clinical Trial Network - 7080 Southwest Fwy
Houston, Texas, 77074-2085
Djamchid Lotfi, Site 1004, 713-484-6947
- Withdrawn
Local Institution - 1031
Irvine, California, 92612-1246
- Not yet recruiting
Local Institution - 1254
Kirkland, Washington, 98034-3030
Site 1254
- Withdrawn
Local Institution - 1142
Lancaster, California, 93534-2839
- Withdrawn
Local Institution - 1127
Largo, Florida, 33777-1359
- Withdrawn
Local Institution - 1230
Long Beach, California, 90805
- Withdrawn
Local Institution - 1117
Los Alamitos, California, 90720-6506
- Recruiting
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles, California, 90033-5313
Lon Schneider, Site 1226, 323-442-3715
- Recruiting
K2 Medical Research - Maitland
Maitland, Florida, 32751-5669
Brandon Lenox, Site 1039, 407-670-5833
- Withdrawn
Local Institution - 1146
Maitland, Florida, 32751-6138
- Withdrawn
Local Institution - 1018
Manhasset, New York, 11030-3816
- Withdrawn
Local Institution - 1114
Marrero, Louisiana, 70072-3083
- Recruiting
AMC Research, LLC - Flourish - PPDS
Matthews, North Carolina, 28105-8336
Mohammad Bolouri, Site 1214, 704-364-4000
- Recruiting
Premier Clinical Research Institute
Miami, Florida, 33122-1335
Emelina Arocha, Site 1021, 305-445-5994
- Recruiting
Angels Clinical Research Institute - Miami
Miami, Florida, 33122-1721
Yanely Pineiro Puebla, Site 1118, 786-218-1733
- Not yet recruiting
Local Institution - 1005
Miami, Florida, 33125-3724
Site 1005
- Recruiting
CCM Clinical Research Group
Miami, Florida, 33133-4231
Francisco Ricart, Site 1108, 208-346-8900
- Recruiting
Wellness Research Center Inc - Miami
Miami, Florida, 33135-1601
Brian Villa, Site 1125, 786-238-7099
- Recruiting
A & D Doctor Center
Miami, Florida, 33135-2968
Yordan Orive Gomez, Site 1236, 305-223-2000
- Recruiting
Floridian Neuroscience Institute-1901 SW 1 St
Miami, Florida, 33135
Emilio Mantero-Atienza, Site 1115, 305-326-0776
- Withdrawn
Local Institution - 1010
Miami, Florida, 33137
- Recruiting
MedOne Clinical Research LLC
Miami, Florida, 33145-2455
Thierry Jacquemin, Site 1143, 305-359-7666
- Recruiting
Allied Biomedical Research Institute
Miami, Florida, 33155-4630
Michael Pfeffer, Site 1009, 866-879-2507
- Recruiting
My Community Research Center, Inc - 7480 Bird Rd
Miami, Florida, 33155-6630
Cesar Guerrero, Site 1113, 786-359-4867
- Recruiting
Future Care Solution LLC
Miami, Florida, 33165-3947
Pilar Trueba, Site 1129, 305-888-0410
- Recruiting
Reliant Medical Research
Miami, Florida, 33165
Carlos Ramirez Calderon, Site 1150, 786-801-0912
- Recruiting
South Florida Research Phase I-IV, Inc. - Miami
Miami, Florida, 33166
Silvia Silva Duluc, Site 1053, 305-669-6166
- Recruiting
Novel Clinical Research Center, LLC -7000 SW 97th Ave
Miami, Florida, 33173-1474
Heber Varela, Site 1006, 000-000-0000
- Recruiting
Dade Research Center - Miami FL - 7600 SW 87th Ave
Miami, Florida, 33173
Maria Nualart, Site 1111, 305-263-7120
- Recruiting
Florida Research Center, Inc.
Miami, Florida, 33174-2950
Sonia Rente, Site 1109, 305-551-8493
- Completed
Local Institution - 1158
Miami, Florida, 33175
- Recruiting
Serenity Research Center
Miami, Florida, 33176-1451
Sergio Jaramillo, Site 1235, 305-596-2080
- Recruiting
IMIC LLC- 9380 SW 150th Str
Miami, Florida, 33176-7947
Leon Ramon, Site 1147, 786-600-7005
- Recruiting
New Gen Health
Miami, Florida, 33176
Roberto Hernando, Site 1234, 305-892-1035
- Completed
Local Institution - 1105
Miami, Florida, 33179-2537
- Recruiting
High Quality Research
Miami, Florida, 33184-1412
Jorge Gonzalez, Site 1157, 305-392-0244
- Recruiting
Coral Research Clinic & Coral Diagnostic Center
Miami, Florida, 33186-4643
Jorge Paoli Bruno, Site 1054, 000-000-0000
- Recruiting
ONHEALTH Research Center
Miami, Florida, 33186-5882
Maria Rodil, Site 1042, 786-808-0832
- Recruiting
New Med Research
Miami Gardens, Florida, 33056-4000
Marta Fernandez, Site 1126, 305-269-7100
- Recruiting
San Marcus Research Clinic Inc
Miami Lakes, Florida, 33014-5602
Nancy Navarro Gonzalez, Site 1032
- Recruiting
Meridian International Research
Miami Lakes, Florida, 33014-6435
Gonzalo Quesada, Site 1102, 305-705-4494
- Withdrawn
Local Institution - 1209
Miami Lakes, Florida, 33014
- Recruiting
Ocean Blue Medical Research Center Inc
Miami Springs, Florida, 33166-5260
Antonio Terrelonge, Site 1026, 305-885-8983
- Not yet recruiting
Local Institution - 1215
Morehead City, North Carolina, 28557
Site 1215
- Not yet recruiting
Local Institution - 1246
Naples, Florida, 34105
Site 1246
- Withdrawn
Local Institution - 1211
Nashville, Tennessee, 37212-3133
- Withdrawn
Local Institution - 1017
New York, New York, 10032
- Not yet recruiting
Local Institution - 1243
North Dartmouth, Massachusetts, 02747-2612
Site 1243
- Not yet recruiting
Local Institution - 1212
Ocoee, Florida, 34761-2964
Site 1212
- Withdrawn
Local Institution - 1101
Okeechobee, Florida, 34972-2568
- Not yet recruiting
Local Institution - 1016
Oklahoma City, Oklahoma, 73112
Site 1016
- Not yet recruiting
Local Institution - 1228
Orange, California, 92868-2847
Site 1228
- Recruiting
Nova Psychiatry
Orlando, Florida, 32803
David Medina, Site 1242, 407-823-8421
- Withdrawn
Local Institution - 1136
Orlando, Florida, 32806-1041
- Recruiting
Combined Research Orlando Phase I-IV LLC
Orlando, Florida, 32807-3555
Eric Carbonell, Site 1112, 407-440-4493
- Recruiting
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174-3101
David McDonald, Site 1204, 386-673-2500
- Recruiting
SC3 Research - Pasadena - 960 E. Green St
Pasadena, California, 91106
M. Lorraine Purino, Site 1043, 626-250-2070
- Withdrawn
Local Institution - 1012
Pensacola, Florida, 32504-8608
- Not yet recruiting
Local Institution - 1217
Phoenix, Arizona, 85006-2528
Site 1217
- Withdrawn
Local Institution - 1044
Phoenix, Arizona, 85012-2836
- Withdrawn
Local Institution - 1238
Plano, Texas, 75093-8225
- Withdrawn
Local Institution - 1137
Port Orange, Florida, 32127-2914
- Withdrawn
Local Institution - 1205
Port Orange, Florida, 32127
- Withdrawn
Local Institution - 1218
Providence, Rhode Island, 02903
- Not yet recruiting
Local Institution - 1213
Rancho Cucamonga, California, 91730
Site 1213
- Withdrawn
Local Institution - 1139
Rochester Hills, Michigan, 48307-2760
- Not yet recruiting
Local Institution - 1210
San Antonio, Texas, 78229-3901
Site 1210
- Withdrawn
Local Institution - 1220
Scottsdale, Arizona, 85260-6742
- Not yet recruiting
Local Institution - 1249
Shaker Heights, Ohio, 44122-5288
Site 1249
- Not yet recruiting
Local Institution - 1252
Shelby, North Carolina, 28150-3803
Site 1252
- Completed
Local Institution - 1103
Sherman Oaks, California, 91403-2131
- Not yet recruiting
Local Institution - 1239
Springfield, Massachusetts, 01103
Site 1239
- Not yet recruiting
Local Institution - 1255
St Louis, Missouri, 63128
Site 1255
- Withdrawn
Local Institution - 1008
St. Petersburg, Florida, 33713-8844
- Withdrawn
Local Institution - 1134
Stafford, Texas, 77477-3929
- Withdrawn
Local Institution - 1013
Stamford, Connecticut, 06905-1206
- Withdrawn
Local Institution - 1034
Stony Brook, New York, 11794-0001
- Completed
Local Institution - 1133
Sweetwater, Florida, 33182
- Withdrawn
Local Institution - 1231
Syracuse, New York, 13203
- Not yet recruiting
Local Institution - 1240
Syracuse, New York, 13210-1718
Site 1240
- Not yet recruiting
Local Institution - 1041
Tampa, Florida, 33607-4629
Site 1041
- Recruiting
Angels Clinical Research Institute Tampa - Palm Springs - PPDS
Tampa, Florida, 33614-2869
Al Robaina, Site 1123, 813-931-0128
- Recruiting
Guardian Angel Research
Tampa, Florida, 33614
Sadaf Bazargan, Site 1124, 813-300-3300
- Recruiting
Interventional Psychiatry of Tampa Bay
Tampa, Florida, 33629-5837
Jamie Fernandez, Site 1110, 813-251-1800
- Withdrawn
Local Institution - 1040
The Villages, Florida, 32159-8955
- Not yet recruiting
Local Institution - 1202
Toms River, New Jersey, 08755
Site 1202
- Withdrawn
Local Institution - 1232
Toms River, New Jersey, 08755
- Withdrawn
Local Institution - 1131
Viera, Florida, 32940
- Recruiting
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
Walnut Creek, California, 94596
Ira Glick, Site 1007, 925-298-5147
- Recruiting
Premiere Research Institute at Palm Beach Neurology, PA
West Palm Beach, Florida, 33407-3209
Paul Winner, Site 1216, 561-845-0500
- Recruiting
Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere, New York, 11598-1739
David Steiner, Site 1025, 516-239-1800
China30 sites, 20 recruiting
- Withdrawn
Local Institution - 7004
Beijing, Beijing Municipality, 100025
- Recruiting
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, 100088
Qinge Zhang, Site 7005, 8613811591959
- Not yet recruiting
Local Institution - 7025
Beijing, Beijing Municipality, 100730
Site 7025
- Not yet recruiting
Local Institution - 7027
Changsha, 410008
Site 7027
- Recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610000
Weihong Kuang, Site 7002, +861898060171
- Withdrawn
Local Institution - 7015
Chongqing, Chongqing Municipality, 400016
- Recruiting
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 0
Xiaomei Zhong, Site 7008, 13242847968
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510120
Jiehao Zhao, Site 7016, +861355619953
- Withdrawn
Local Institution - 7009
Guangzhou, Guangdong, 510260
- Withdrawn
Local Institution - 7017
Hangzhou, Zhejiang, 310003
- Withdrawn
Local Institution - 7010
Hangzhou, Zhejiang, 310013
- Not yet recruiting
Local Institution - 7021
Hangzhou, Zhejiang, 310013
Site 7021
- Recruiting
People's Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310014
Zhengluan Liao, Site 7006, 13958024692
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
Hangzhou, Zhejiang, 310016
Wei Chen, Site 7020, +86 138 0573 6335
- Withdrawn
Local Institution - 7007
Hefei, Anhui, 230022
- Not yet recruiting
Local Institution - 7022
Kunming, 650032
Site 7022
- Withdrawn
Local Institution - 7012
Nanchang, Jiangxi, 330008
- Withdrawn
Local Institution - 7014
Nanjing, Jiangsu, 210009
- Recruiting
The Second Affiliated Hospital of Nanjing Medical University - Main Campus
Nanjing, Jiangsu, 210011
Meijiang Feng, Site 7013, 8618951762651
- Not yet recruiting
Local Institution - 7024
Nanjing, Jiangsu, 210029
Site 7024
- Not yet recruiting
Local Institution - 7030
Ningbo, Zhejiang, 315016
Site 7030
- Recruiting
Shanghai Mental Health Center - PPDS
Shanghai, Shanghai Municipality, 200030
Xia Li, Site 7001, +861377427254
- Recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065
Xijin Wang, Site 7028
- Withdrawn
Local Institution - 7011
Shanghai, Shanghai Municipality, 200080
- Not yet recruiting
Local Institution - 7026
Shanghai, Shanghai Municipality, 200233
Site 7026
- Recruiting
Shenzhen Kangning Hospital
Shenzhen, Guangdong, 518118
Yongjun Wang, Site 7003, 8613632587615
- Recruiting
Tianjin Anding Hospital(Tianjin mental Health Center)
Tianjin, Tianjin Municipality, 300222
Daliang Sun, Site 7019, +8615122889423
- Withdrawn
Local Institution - 7018
Wenzhou, Zhejiang, 325000
- Not yet recruiting
Local Institution - 1-14J7PZ32
Xi'an, Shan1xi, 710061
Site 1-14J7PZ32
- Not yet recruiting
Local Institution - 7023
Zhenjiang, Jiangsu, 212001
Site 7023
Japan27 sites, 24 recruiting
- Not yet recruiting
Local Institution - 7518
Hachiōji, Tokyo, 193-0811
Site 7518
- Not yet recruiting
Local Institution - 7505
Hadano, Kanagawa, 257-0003
Site 7505
- Not yet recruiting
Local Institution - 7526
Himeji-Shi, Hyōgo, 672-8044
Site 7526
- Recruiting
Funairi nou clinic
Hiroshima, 730-0844
Tomoko Murakami, Site 7516
- Withdrawn
Local Institution - 1-13H98LYW
Iizuka, Fukuoka, 820-0014
- Withdrawn
Local Institution - 7503
Iizuka, Fukuoka, 820-0014
- Recruiting
Koukan Clinic
Kawasaki-Shi, Kanagawa, 210-0852
Yasuhiro Yoshii, Site 7507, 81443668900
- Not yet recruiting
Local Institution - 7525
Kōriyama, Fukushima, 963-8052
Site 7525
- Not yet recruiting
Local Institution - 1-13H98LTZ
Kumamoto, 861-8002
Site 1-13H98LTZ
- Not yet recruiting
Local Institution - 7524
Kumamoto, 861-8002
Site 7524
- Recruiting
National Hospital Organization Utano National Hospital
Kyoto, Kyoto, 616-8255
Shinji Sudoh, Site 7511, 81-75-461-5121
- Recruiting
Asakayama General Hospital
Sakai, Osaka, 590-0018
Kazue Kamae, Site 7509, 0722294882
- Not yet recruiting
Local Institution - 7522
Sapporo, Hokkaido, 006-8555
Site 7522
- Not yet recruiting
Local Institution - 7521
Setagaya-Ku, Tokyo, 154-0004
Site 7521
- Recruiting
Kurumi Clinic
Setagaya-Ku, Tokyo, 156-0041
Chika Nishimura, Site 7519, 81333277462
- Not yet recruiting
Local Institution - 7528
Setagaya-Ku, Tokyo, 156-0057
Site 7528
- Not yet recruiting
Local Institution - 7527
tabashi City, Tokyo, 173-0015
Site 7527
- Not yet recruiting
Local Institution - 7514
Takamatsu, Kagawa-ken, 760-0065
Site 7514
- Not yet recruiting
Local Institution - 7501
Takatsuki, Osaka, 569-1041
Site 7501
- Not yet recruiting
Local Institution - 7523
Tatebayashi, 374-0037
Site 7523
- Withdrawn
Local Institution - 1-13H98LIT
Toride-shi, Ibaraki, 302-0004
- Recruiting
Memory Clinic Toride
Toride-shi, Ibaraki, 302-0004
Youshun Boku, Site 7508, +297796166
- Not yet recruiting
Local Institution - 7506
Tsu, Mie-ken, 514-1101
Site 7506
- Not yet recruiting
Local Institution - 7520
Yokohama, Kanagawa, 230-0074
Site 7520
- Recruiting
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, 2310801
Takuya Ohkubo, Site 7502, 0456286100
- Recruiting
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
Keiko Ide, Site 7513, 81457872800
- Not yet recruiting
Local Institution - 7512
Yoshinogawa, Tokushima, 776-8585
Site 7512
Italy18 sites, 7 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
Baggiovara, Modena, 41126
Giovanna Zamboni, Site 2306, +390593962201
- Recruiting
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, Lombardy, 25125
Stefania Orini, Site 2324
- Withdrawn
Local Institution - 1-13JED83E
Brescia, Lombardy, 25125
- Withdrawn
Local Institution - 2308
Florence, Tuscany, 50139
- Withdrawn
Local Institution - 2304
Milan, Lombardy, 20122
- Not yet recruiting
Local Institution - 2323
Milan, Lombardy, 20149
Site 2323
- Withdrawn
Local Institution - 2305
Monza, 20900
- Withdrawn
Local Institution - 2302
Pisa, 56126
- Not yet recruiting
Local Institution - 2307
Ponderano (Biella), Piedmont, 13875
Site 2307
- Not yet recruiting
Local Institution - 2303
Roma, 00168
Site 2303
- Not yet recruiting
Local Institution - 2309
Roma, 00189
Site 2309
- Withdrawn
Local Institution - 1-13JED80W
Rome, Lazio, 00161
- Not yet recruiting
Local Institution - 2322
Rome, Lazio, 00161
Site 2322
- Withdrawn
Local Institution - 1-13JED82O
Rome, Lazio, 00166
- Withdrawn
Local Institution - 2320
Rome, Lazio, 00166
- Withdrawn
Local Institution - 2301
Rome, Lazio, 00179
- Withdrawn
Local Institution - 2321
Rome, Roma, 00186
- Withdrawn
Local Institution - 1-140JNJT7
Salerno, Campania, 84131
Poland17 sites, 10 recruiting
- Withdrawn
Local Institution - 4204
Bydgoszcz, 85-080
- Recruiting
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
Gdansk, Pomeranian Voivodeship, 80-214
Adam Wlodarczyk, Site 4212, 48583493720
- Withdrawn
Local Institution - 1-13JAX170
Gdansk, Pomeranian Voivodeship, 80-952
- Not yet recruiting
Local Institution - 4215
Iława, Warmian-Masurian Voivodeship, 14-200
Site 4215
- Withdrawn
Local Institution - 4208
Katowice, 40-156
- Withdrawn
Local Institution - 4205
Katowice, 40-282
- Withdrawn
Local Institution - 4213
Kielce, 25-411
- Not yet recruiting
Local Institution - 4217
Lodz, Lódzkie, 90-302
Site 4217
- Recruiting
Medycyna Milorzab sp. z o.o.
Lodz, 90-227
Jakub Kazmierski, Site 4202
- Recruiting
Pro Salus Sp. z o.o.,sp. k.
Lodz, 91-743
Lukasz Jasek, Site 4214
- Recruiting
Osrodek Badan Klinicznych Appletreeclinics
Lódz, Lódzkie, 90-349
Elzbieta Wagenknecht, Site 4207, +48602242959
- Recruiting
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska -Lublin
Lublin, 20-064
Marcin Nastaj, Site 4206, +48793418181
- Recruiting
Centrum Medyczne HCP Szpital im. Jana Pawla II
Poznan, Greater Poland Voivodeship, 61-485
Przemyslaw Osip, Site 4210, 48604116632
- Recruiting
Osrodek Badawczo Naukowo Dydaktyczny Chorób Otepiennych im Ksiedza Henryka Kardynala Gulbinowicza
Ścinawa, 59-330
Izabela Winkel, Site 4201, +48609034771
- Withdrawn
Local Institution - 4209
Siemianowice Śląskie, 41-100
- Not yet recruiting
Local Institution - 4216
Sochaczew, 96-500
Site 4216
- Withdrawn
Local Institution - 4211
Wroclaw, 50-981
South Korea17 sites, 10 recruiting
- Withdrawn
Local Institution - 7214
Ansan-si, Gyeonggido, 15355
- Withdrawn
Local Institution - 7208
Buk-gu, Daegu Gwang'yeogsi, 41404
- Recruiting
Hallym University Chuncheon Sacred Heart Hospital
Gangwon-do, 200-704
Do-Hoon Kim, Site 7218, 821041512959
- Withdrawn
Local Institution - 7205
Incheon, Incheon Gwang'yeogsi, 21565
- Withdrawn
Local Institution - 7207
Seongnam-si, Gyeonggido, 13496
- Withdrawn
Local Institution - 7202
Seongnam-si, 0
- Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080
Manho Kim, Site 7206, +82-2-2072-2193
- Not yet recruiting
Local Institution - 7217
Seoul, Seoul Teugbyeolsi, 06591
Site 7217
- Not yet recruiting
Local Institution - 7213
Seoul, Seoul Teugbyeolsi, 07804
Site 7213
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul, Seoul Teugbyeolsi, 7985
Geon Ha Kim, Site 7215, 82226505298
- Not yet recruiting
Local Institution - 7219
Seoul, 06273
Site 7219
- Withdrawn
Local Institution - 7203
Seoul, 07071
- Withdrawn
Local Institution - 7201
Seoul, 143-729
- Recruiting
Hanyang University Seoul Hospital
Seoul, 4763
Hee Jin Kim, Site 7211, +82222908374
- Not yet recruiting
Local Institution - 7210
Seoul, 6351
Site 7210
- Recruiting
The Catholic University of Korea, Yeouido St. Mary's Hospital
Yeongdeungpo-gu, Seoul Teugbyeolsi, 07345
Hyun-Kook Lim, Site 7212
- Not yet recruiting
Local Institution - 7216
Yongin-si, Gyeonggido, 16995
Site 7216
Brazil13 sites, 7 recruiting
- Withdrawn
Local Institution - 1-13J38ZST
Brasília, Federal District, 70200-730
- Not yet recruiting
Local Institution - 6201
Brasília, Federal District, 70200-730
Site 6201
- Withdrawn
Local Institution - 1-13J338E3
Rio de Janeiro, 22270060
- Recruiting
Ruschel Medicina
Rio de Janeiro, 22270060
Sandra Ruschel, Site 6204, 5521999822072
- Recruiting
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, São Paulo, 01228-000
Leonel Takada, Site 6202, 558888888888
- Withdrawn
Local Institution - 1-13J38ZS5
São Paulo, São Paulo, 01228-000
- Recruiting
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, 01236-030
Acioly Lacerda, Site 6206, +551938639438
- Withdrawn
Local Institution - 1-13J38ZTW
São Paulo, São Paulo, 01236-030
- Not yet recruiting
Local Institution - 6207
São Paulo, São Paulo, 01327-001
Site 6207
- Withdrawn
Local Institution - 1-13J38ZSH
São Paulo, São Paulo, 05403-010
- Withdrawn
Local Institution - 1-13J38ZRS
São Paulo, São Paulo, 87013-250
- Not yet recruiting
Local Institution - 6203
São Paulo, São Paulo, 87013-250
Site 6203
- Recruiting
Instituto de Psiquiatria HC FMUSP
São Paulo, 05403-010
Tania Correa de Toledo Ferraz, Site 6205
Serbia13 sites, 10 recruiting
- Withdrawn
Local Institution - 4307
Belgrade, Belgrade, 101403
- Not yet recruiting
Local Institution - 4302
Belgrade, Belgrade, 11000
Site 4302
- Recruiting
Clinical Hospital Center Dragisa Misovic Dedinje
Belgrade, 11000
Vladimir Diligenski, Site 4306, +381637708765
- Not yet recruiting
Local Institution - 4308
Belgrade, 11000
Site 4308
- Recruiting
Military Medical Academy
Belgrade, 11000
Ranko Raicevic, Site 4304, 381113609206
- Withdrawn
Local Institution - 1-13JAX17Q
Gornja Toponica, 705631
- Recruiting
Special Hospital for Psychiatric Diseases "Gornja Toponica"
Gornja Toponica, 705631
Milan Stanojkovic, Site 4312, 382+11
- Recruiting
Special Hospital for Psychiatric Diseases Kovin
Kovin, 26220
Jovanka Petrovic, Site 4305, +38163529054
- Not yet recruiting
Local Institution - 4301
Kragujevac, 34000
Site 4301
- Not yet recruiting
Local Institution - 4310
Kragujevac, 34000
Site 4310
- Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
Dragana Ignjatovic Ristic, Site 4303, +38163685994
- Not yet recruiting
Local Institution - 4309
Novi Sad, 21000
Site 4309
- Withdrawn
Local Institution - 4311
Vršac, 26300
Spain11 sites, 8 recruiting
- Withdrawn
Local Institution - 2205
Barcelona, 8028
- Withdrawn
Local Institution - 2212
Lleida, 25198
- Withdrawn
Local Institution - 2207
Madrid, 28006
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Jordi Matias Guiu, Site 2210
- Not yet recruiting
Local Institution - 2211
Majadahonda, Madrid, 28222
Site 2211
- Not yet recruiting
Local Institution - 2213
Málaga, Málaga, 29004
Site 2213
- Recruiting
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, 37007
Angel Montejo Gonzalez, Site 2204, +34923126580
- Not yet recruiting
Local Institution - 2201
Seville, 41009
Site 2201
- Recruiting
Hospital Universitario Rio Hortega
Valladolid, 47012
Juan Muñoz Sanchez, Site 2203, +34679279973
- Not yet recruiting
Local Institution - 2202
Zamora, 49021
Site 2202
- Recruiting
Hospital Viamed Montecanal
Zaragoza, 50012
Antonio Oliveros-Cid, Site 2206, +34670492099
Argentina9 sites, 9 recruiting
- Not yet recruiting
Local Institution - 5002
Buenos Aires, 1199
Site 5002
- Recruiting
Organización Médica de Investigación
Buenos Aires, C1015ABO
Daniel Politis, Site 5009, +541150319700
- Not yet recruiting
Local Institution - 5006
Buenos Aires, C1428AQK
Site 5006
- Not yet recruiting
Local Institution - 5004
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1056
Site 5004
- Not yet recruiting
Local Institution - 5005
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1058AAJ
Site 5005
- Not yet recruiting
Local Institution - 5001
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1107
Site 5001
- Not yet recruiting
Local Institution - 5007
Córdoba, 5000
Site 5007
- Not yet recruiting
Local Institution - 5003
Córdoba, 5004
Site 5003
- Not yet recruiting
Local Institution - 5008
Rosario, Santa Fe Province, S2000DEJ
Site 5008
United Kingdom9 sites
- Withdrawn
Local Institution - 2105
Aberdeen, AB25 2ZL
- Withdrawn
Local Institution - 2109
Chertsey, KT16 9AU
- Withdrawn
Local Institution - 2110
Ilford, Greater London, IG1 4HP
- Withdrawn
Local Institution - 2106
Leeds, LS7 3JX
- Withdrawn
Local Institution - 2104
Motherwell, ML1 4UF
- Withdrawn
Local Institution - 2111
Preston, PR2 9HT
- Withdrawn
Local Institution - 2107
Sheffield, SouthYorkshire, s5 7JT
- Withdrawn
Local Institution - 2103
Swindon, SN3 6BW
- Withdrawn
Local Institution - 2108
Swinton, Greater Manchester, M27 8FF
Bulgaria8 sites, 6 recruiting
- Recruiting
Medical Center Medconsult Pleven OOD
Pleven, 5800
Maria Aleksandrova, Site 4503, +35964910999
- Recruiting
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd
Plovdiv, 4001
Penka Atanasova, Site 4508
- Recruiting
University Multiprofile Hospital For Active Treatment Kanev AD
Rousse, 7002
Neli Petrova, Site 4507, 359888793906
- Withdrawn
Local Institution - 4505
Sofia, Sofia-Grad, 1431
- Withdrawn
Local Institution - 4502
Sofia, Sofia-Grad, 1510
- Not yet recruiting
Local Institution - 4506
Sofia, Sofia-Grad, 1680
Site 4506
- Recruiting
Medical Center Sveti Naum EOOD
Sofia, 1113
Assen Karadaliev, Site 4501, +359888220704
- Not yet recruiting
Local Institution - 4509
Sofia, 1164
Site 4509
Germany8 sites, 3 recruiting
- Withdrawn
Local Institution - 2403
Bayreuth, Bavaria, 95445
- Withdrawn
Local Institution - 2401
Böblingen, Baden-Wurttemberg, 71034
- Not yet recruiting
Local Institution - 2407
Böblingen, Baden-Wurttemberg, 71034
Site 2407
- Withdrawn
Local Institution - 1-13JED8BL
Erbach im Odenwald, Hesse, 64711
- Not yet recruiting
Local Institution - 2404
Erbach im Odenwald, 64711
Site 2404
- Withdrawn
Local Institution - 1-13JED842
Frankfurt am Main, 60528
- Not yet recruiting
Local Institution - 2405
Frankfurt am Main, 60528
Site 2405
- Withdrawn
Local Institution - 2402
Homburg, Saarland, 66424
Hungary8 sites, 4 recruiting
- Not yet recruiting
Local Institution - 4602
Budapest, 1083
Site 4602
- Not yet recruiting
Local Institution - 4612
Budapest, 1123
Site 4612
- Withdrawn
Local Institution - 1-13JED8D1
Gyöngyös, 3200
- Not yet recruiting
Local Institution - 4611
Gyöngyös, 3200
Site 4611
- Withdrawn
Local Institution - 4603
Miskolc, 3526
- Not yet recruiting
Local Institution - 4601
Pécs, Baranya, 7633
Site 4601
- Withdrawn
Local Institution - 1-13JED893
Szeged, Csongrád megye, 6720
- Withdrawn
Local Institution - 4610
Szeged, Csongrád megye, 6720
Ukraine8 sites, 8 recruiting
- Not yet recruiting
Local Institution - 8003
Khmelnytskyi, 32120
Site 8003
- Not yet recruiting
Local Institution - 8007
Lviv, Lviv Oblast, 79053
Site 8007
- Not yet recruiting
Local Institution - 8006
Lviv, 79035
Site 8006
- Not yet recruiting
Local Institution - 8004
Smila, 20708
Site 8004
- Not yet recruiting
Local Institution - 8008
Ternopil, 46027
Site 8008
- Not yet recruiting
Local Institution - 8005
Uzhhorod, 88000
Site 8005
- Not yet recruiting
Local Institution - 8002
Vinnytsia, Vinnytsia Oblast, 21005
Site 8002
- Not yet recruiting
Local Institution - 8001
Vinnytsia, Vinnytsia Oblast, Ukraine
Site 8001
Belgium7 sites, 3 recruiting
- Withdrawn
Local Institution - 1-13JED87R
Alken, 3570
- Completed
Local Institution - 2804
Alken, 3570
- Withdrawn
Local Institution - 2801
Hasselt, Limburg, 3500
- Not yet recruiting
Local Institution - 2806
Jette, Brussels Capital, 1090
Site 2806
- Not yet recruiting
Local Institution - 2805
Kortrijk, 8500
Site 2805
- Withdrawn
Local Institution - 2802
Leuven, Vlaams Brabant, 3000
- Not yet recruiting
Local Institution - 2803
Roeselare, West-Vlaanderen, 8800
Site 2803
Croatia7 sites, 5 recruiting
- Recruiting
Klinicki Bolnicki Centar Zagreb
Zagreb, City of Zagreb, 10000
Natasa Klepac, Site 4105, 38598541880
- Withdrawn
Local Institution - 1-140R4546
Zagreb, City of Zagreb, 10000
- Not yet recruiting
Local Institution - 4102
Zagreb, City of Zagreb, 10000
Site 4102
- Withdrawn
Local Institution - 4103
Zagreb, City of Zagreb, 10000
- Not yet recruiting
Local Institution - 4106
Zagreb, City of Zagreb, 10000
Site 4106
- Recruiting
Klinika za psihijatriju Vrapce
Zagreb, City of Zagreb, 10090
Ninoslav Mimica, Site 4101, +38513780678
- Not yet recruiting
Local Institution - 4104
Zagreb, City of Zagreb, 10090
Site 4104
Greece7 sites, 1 recruiting
- Withdrawn
Local Institution - 4805
Athens, Attica, 115 21
- Withdrawn
Local Institution - 4803
Athens, Attica, 115 26
- Withdrawn
Local Institution - 4802
Chaidari, Athens, Attica, 12462
- Recruiting
University General Hospital of Heraklion
Heraklion, 71110
Ioannis Zaganas, Site 4801
- Withdrawn
Local Institution - 4810
Kalyftaki-N. Kifissia, Attica, 145 64
- Withdrawn
Local Institution - 4806
Marousi, Attica, 151 23
- Withdrawn
Local Institution - 4811
Thessaloniki, 546 36
Mexico7 sites, 3 recruiting
- Recruiting
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, 80020
Elmer Lopez Meza, Site 1501, +526677587952
- Withdrawn
Local Institution - 1506
México, 03100
- Recruiting
Hospital Universitario Dr. Jose Eleuterio González
Monterrey, Nuevo León, 64460
Ricardo Salinas, Site 1503, +528181232436
- Withdrawn
Local Institution - 1505
Monterrey, Nuevo León, 64620
- Recruiting
Hospital Universitario de Saltillo Dr Gonzalo Valdes Valdes
Saltillo Centro, Coahuila, 25000
Mario Valdes, Site 1502, 528441258992
- Withdrawn
Local Institution - 1507
Zapopan, Jalisco, 45170
- Withdrawn
Local Institution - 1504
Zona Urbana Río Tijuana, Estado de Baja California, 22010
Slovakia7 sites, 5 recruiting
- Recruiting
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
Banská Bystrica, 974 04
Beata Dupejova, Site 4401, +421484124549
- Recruiting
KONZILIUM s.r.o
Dubnica nad Váhom, 018 41
Magdalena Perichtova, Site 4402, +421424426231
- Recruiting
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
Košice, Košice Region, 041 90
Slavka Dubinska, Site 4405, +421556152721
- Recruiting
EPAMED s.r.o
Košice, 040 01
Eva Palova, Site 4406, +421556402727
- Withdrawn
Local Institution - 1-13JED85D
Pezinok, 902 18
- Completed
Local Institution - 4407
Pezinok, 902 18
- Recruiting
Crystal Comfort, s.r.o.
Vranov nad Topľou, 093 01
Dagmar Breznoscakova, Site 4403, +421574880251
India6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 7406
Ajmer, Rajasthan, 305001
Site 7406
- Not yet recruiting
Local Institution - 7405
Chandigarh, Punjab, 160012
Site 7405
- Not yet recruiting
Local Institution - 7403
Hyderabad, 500034
Site 7403
- Not yet recruiting
Local Institution - 7404
Kolkata, 700017
Site 7404
- Not yet recruiting
Local Institution - 7401
Nagpur, Maharashtra, 440010
Site 7401
- Not yet recruiting
Local Institution - 7402
Varanasi, 211 005
Site 7402
Portugal6 sites, 1 recruiting
- Withdrawn
Local Institution - 2701
Guimarães, Braga District, 4835-044
- Withdrawn
Local Institution - 2704
Lisbon, Lisbon District, 1349-019
- Recruiting
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, 1649-035
Ana Verdelho, Site 2705, 3512178050x50
- Withdrawn
Local Institution - 2706
Lisbon, 1998-018
- Withdrawn
Local Institution - 2703
Matosinhos Municipality, Porto District, 4454-509
- Withdrawn
Local Institution - 2702
Torres Vedras, Lisbon District, 2560-280
Romania6 sites, 6 recruiting
- Not yet recruiting
Local Institution - 1-14JIMILF
Bucharest, 11241
Site 1-14JIMILF
- Recruiting
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
Bucharest, 40874
Mihaela-Cleopatra Rosca, Site 4906, +40745588989
- Not yet recruiting
Local Institution - 4902
Constanța, 90123
Site 4902
- Not yet recruiting
Local Institution - 4903
Craiova, 200157
Site 4903
- Recruiting
CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie
Oradea, Bihor County, 410027
Elena Daniela Buhas Ramocea, Site 4904, 0040747056934
- Recruiting
S.C. Carpe Diem SRL
Sibiu, 550281
Cosmina Muntean, Site 4901, 4026944141x5
Turkey (Türkiye)6 sites, 6 recruiting
- Recruiting
Hacettepe University Medical Faculty
Ankara, 06230
Gul Yalcin Cakmakli, Site 4706
- Not yet recruiting
Local Institution - 4702
Atakum, Samsun, 55139
Site 4702
- Not yet recruiting
Local Institution - 4701
Eskişehir, 26040
Site 4701
- Not yet recruiting
Local Institution - 4704
Istanbul, 34093
Site 4704
- Not yet recruiting
Local Institution - 4705
Izmir, 35210
Site 4705
- Not yet recruiting
Local Institution - 4703
Izmir, 35370
Site 4703
Canada5 sites
- Withdrawn
Local Institution - 1-12IRCCNP
Calgary, Alberta, T2N 1N4
- Withdrawn
Local Institution - 1603
Hamilton, Ontario, ON L8M 1W9
- Withdrawn
Local Institution - 1-12IYJCH7
Montreal, Quebec, H4H 1R3
- Withdrawn
Local Institution - 1601
Verdun, Quebec, H4H 1R3
- Withdrawn
Local Institution - 1604
Whitby, Ontario, L1N 5S9
Czechia5 sites, 4 recruiting
- Recruiting
Neuroterapie KH, s.r.o
Kutná Hora, 284 01
Slavomír Pietrucha, Site 4001, 420777551077
- Recruiting
A-SHINE s.r.o.
Pilsen, 301 00
Lubos Janu, Site 4005, 420777242101
- Recruiting
CLINTRIAL s.r.o.
Prague, Praha, Hlavní Mesto, 100 00
Zdenek Solle, Site 4002, +420222510607
- Withdrawn
Local Institution - 4004
Prague, 140 00
- Not yet recruiting
Local Institution - 4006
Rychnov nad Kněžnou, 516 01
Site 4006
France5 sites, 3 recruiting
- Withdrawn
Local Institution - 2510
Nice, Alpes-Maritimes, 06100
- Withdrawn
Local Institution - 2501
Reims, Marne, 51100
- Recruiting
Centre Hospitalier Universitaire Hopitaux de Rouen-1 Rue de Germont
Rouen, Seine-Maritime, 76031
David Wallon, Site 2503, +33232888740
- Not yet recruiting
Local Institution - 2513
Toulouse, 31059
Site 2513
- Not yet recruiting
Local Institution - 2511
Tours, Indre-et-Loire, 37044
Site 2511
Puerto Rico5 sites, 2 recruiting
- Withdrawn
Local Institution - 1303
Bayamón, 00961-6910
- Withdrawn
Local Institution - 1301
Bayamón, 961
- Withdrawn
Local Institution - 1305
Carolina, 983
- Not yet recruiting
Local Institution - 1302
San Juan, 00918-4502
Site 1302
- Recruiting
Barbara Diaz Hernandez MD Research Inc
San Juan, 00926-3160
Ileana Fumero-Perez, Site 1304
Israel4 sites, 4 recruiting
- Not yet recruiting
Local Institution - 3103
Ashkelon, Tel Aviv, 7830604
Site 3103
- Not yet recruiting
Local Institution - 3101
Jerusalem, Jerusalem, 90000
Site 3101
- Not yet recruiting
Local Institution - 3102
Petah Tikva, 49100
Site 3102
- Not yet recruiting
Local Institution - 3104
Ramat Gan, 5265601
Site 3104
Chile3 sites, 3 recruiting
- Recruiting
Psicomed Estudios Medicos
Antofagasta, 1270244
Luis Barra, Site 6003, +56552240334
- Recruiting
Especialidades Medicas L Y S
Las Condes, 7550000
Manuel Lavados Montes, Site 6001, +56222016979
- Recruiting
Biomedica Research Group
Providencia, Santiago Metropolitan, 7500000
Sergio Gloger Kojchen, Site 6002, +56226758700
Peru2 sites
- Withdrawn
Local Institution - 6101
Callao, Callao 2
- Withdrawn
Local Institution - 6102
Miraflores, Lima region, 15046
About this study
This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.
- Being tested
- KarXT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXTDrug
KarXT 20/2 mg TID (total daily dose [TDD] 60/6 mg) KarXT 30/3 mg TID (TDD 90/9 mg) KarXT 40/4 mg TID (TDD 120/12 mg) KarXT 50/5 mg TID (TDD 150/15 mg) KarXT 66.7/6.67 mg TID (TDD 200/20 mg)
| Study group | Role | What they receive |
|---|---|---|
| KarXT | Experimental | Xanomeline and Trospium Chloride Capsules Receives: Drug: KarXT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
The number and percentage of participants with TEAEs will be determined
Measured: From initial dose through 14 days after the final dose (up to 54 weeks)
Secondary outcomes (2)
Incidence of serious TEAEs
The number and percentage of participants with serious TEAEs will be determined
Measured: From initial dose through 14 days after the final dose (up to 54 weeks)
Incidence of TEAEs leading to withdrawal
The number and percentage of participants with TEAEs leading to withdrawal will be determined
Measured: From initial dose through 14 days after the final dose (up to 54 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start11 Jul 2023
- Primary completion7 Sep 2027 (estimated)
- Study completion7 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosis Associated With Alzheimer's DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980949
- Sponsor's protocol ID
- CN012-0028
- Other IDs
- CN012-0028, KAR-033, 2023-504151-27, 2023
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2023
- 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