A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) (ADEPT-4)

August 25, 2026 updated by: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

The purpose of this study is to evaluate the safety and efficacy of KarXT in adult participants with mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

406

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

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

Study Contact Backup

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

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 1199
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • Maria Cecilia Fernandez, Site 5002
          • Phone Number: 5411500000x00
      • Buenos Aires, Argentina, C1015ABO
        • Recruiting
        • Organizacion Medica de Investigacion
        • Contact:
          • Daniel Politis, Site 5009
          • Phone Number: +541150319700
      • Buenos Aires, Argentina, C1428AQK
        • Recruiting
        • Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI
        • Contact:
          • Pablo Bagnati, Site 5006
          • Phone Number: 542234000000
      • Córdoba, Argentina, 5004
        • Recruiting
        • Instituto Privado Kremer
        • Contact:
          • Leonardo Kremer, Site 5003
          • Phone Number: 543515000000
      • Córdoba, Argentina, 5000
        • Recruiting
        • Centro Especializado en Neurociencias - CEN
        • Contact:
          • Hernán Ruggeri, Site 5007
          • Phone Number: +543514512141
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1056
        • Recruiting
        • CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215
        • Contact:
          • Griselda Russo, Site 5004
          • Phone Number: 8888888888
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1107
        • Recruiting
        • Fundación para el Estudio y Tratamiento de Enfermedades mentales- FETEM
        • Contact:
          • Ricardo Corral, Site 5001
          • Phone Number: 5491144455572
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1058AAJ
        • Recruiting
        • Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.
        • Contact:
          • Enrique Kuper, Site 5005
          • Phone Number: 541143000000
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Recruiting
        • Instituto Medico de la Fundacion Estudios Clinicos
        • Contact:
          • Javier Travella, Site 5008
  • Belgium
      • Alken, Belgium, 3570
        • Completed
        • Local Institution - 2804
      • Bruges, Belgium, 8000
        • Withdrawn
        • Local Institution - 2807
      • Kortrijk, Belgium, 8500
        • Completed
        • Local Institution - 2805
    • Brussels Capital
      • Jette, Brussels Capital, Belgium, 1090
        • Completed
        • Local Institution - 2806
    • West-Vlaanderen
      • Roeselare, West-Vlaanderen, Belgium, 8800
        • Completed
        • Local Institution - 2803
  • Brazil
      • Rio de Janeiro, Brazil, 22270060
        • Recruiting
        • Ruschel Medicina
        • Contact:
          • Sandra Ruschel, Site 6204
          • Phone Number: 5521999822072
      • São Paulo, Brazil, 05403-010
        • Recruiting
        • Instituto de Psiquiatria HC FMUSP
        • Contact:
          • Tania Correa de Toledo Ferraz, Site 6205
    • Federal District
      • Brasília, Federal District, Brazil, 70200-730
        • Recruiting
        • L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
        • Contact:
          • Eduardo Vasconcellos, Site 6201
          • Phone Number: 55-6199983-1080
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01228-000
        • Recruiting
        • CPQuali Pesquisa Clínica Sao Paulo
        • Contact:
          • Leonel Takada, Site 6202
          • Phone Number: 558888888888
      • São Paulo, São Paulo, Brazil, 01236-030
        • Recruiting
        • BR Trials - Pesquisa Clínica
        • Contact:
          • Acioly Lacerda, Site 6206
          • Phone Number: +551938639438
      • São Paulo, São Paulo, Brazil, 87013-250
        • Recruiting
        • Clinilive
        • Contact:
          • Antonio Carlos Da Silva, Site 6203
      • São Paulo, São Paulo, Brazil, 01327-001
        • Recruiting
        • Hospital Alemao Oswaldo Cruz (HAOC)
        • Contact:
          • Diogo Santos, Site 6207
  • Bulgaria
      • Plovdiv, Bulgaria, 4001
        • Recruiting
        • University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd
        • Contact:
          • Penka Atanasova, Site 4508
      • Rousse, Bulgaria, 7002
        • Recruiting
        • University Multiprofile Hospital For Active Treatment Kanev AD
        • Contact:
          • Neli Petrova, Site 4507
          • Phone Number: 359888793906
      • Sofia, Bulgaria, 1164
        • Recruiting
        • Medical Center Medika 2005 - Branch Sofia
        • Contact:
          • Plamen Tsvetanov, Site 4509
      • Sofia, Bulgaria, 1408
        • Withdrawn
        • Local Institution - 4510
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1680
        • Completed
        • Local Institution - 4506
  • China
      • Changsha, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Lu Shen, Site 7027
          • Phone Number: 073189753041
      • Kunming, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Jin Lu, Site 7022
          • Phone Number: 8613530000000
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Recruiting
        • Beijing Hospital
        • Contact:
          • Haibo Chen, Site 7025
          • Phone Number: 8613910000000
      • Beijing, Beijing Municipality, China, 100088
        • Recruiting
        • BEIjing AnDing hospital capital medical university
        • Contact:
          • Qinge Zhang, Site 7005
          • Phone Number: 8613811591959
      • Beijing, Beijing Municipality, China, 100025
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
          • Dantao Peng, Site 7004
          • Phone Number: 8613910908579
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Yang Lv, Site 7015
          • Phone Number: +861361823653
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Jiehao Zhao, Site 7016
          • Phone Number: +861355619953
      • Guangzhou, Guangdong, China
        • Withdrawn
        • Local Institution - 7008
      • Shenzhen, Guangdong, China, 518118
        • Recruiting
        • Shenzhen Kangning Hospital
        • Contact:
          • Yongjun Wang, Site 7003
          • Phone Number: 8613632587615
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Nanjing Brain Hospital
        • Contact:
          • Weiwei Jiang, Site 7024
          • Phone Number: 13372003816
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University - Main Campus
        • Contact:
          • Meijiang Feng, Site 7013
          • Phone Number: 8618951762651
      • Zhenjiang, Jiangsu, China, 212001
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Contact:
          • Ming Yu, Site 7023
          • Phone Number: 8613860000000
    • Shan1xi
      • Xi'an, Shan1xi, China, 710061
        • Recruiting
        • The Mental Health Center of Xi'an
        • Contact:
          • Wei Dang, Site 7029
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200065
        • Recruiting
        • Tongji Hospital of Tongji University
        • Contact:
          • Xijin Wang, Site 7028
      • Shanghai, Shanghai Municipality, China, 200030
        • Recruiting
        • Shanghai Mental Health Center - PPDS
        • Contact:
          • Xia Li, Site 7001
          • Phone Number: +861377427254
      • Shanghai, Shanghai Municipality, China, 200233
        • Not yet recruiting
        • Local Institution - 7026
        • Contact:
          • Site 7026
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital Sichuan University
        • Contact:
          • Weihong Kuang, Site 7002
          • Phone Number: +861898060171
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300222
        • Recruiting
        • Tianjin Anding Hospital(Tianjin mental Health Center)
        • Contact:
          • Daliang Sun, Site 7019
          • Phone Number: +8615122889423
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital
        • Contact:
          • Zhengluan Liao, Site 7006
          • Phone Number: 13958024692
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qiantang Campus
        • Contact:
          • Wei Chen, Site 7020
          • Phone Number: +86 138 0573 6335
      • Hangzhou, Zhejiang, China, 310013
        • Recruiting
        • Zhejiang Hospital - Lingyin Campus
        • Contact:
          • Xiaoli Liu, Site 7021
          • Phone Number: +865718798737
      • Ningbo, Zhejiang, China, 315201
        • Recruiting
        • The Affiliated Kangning Hospital of Ningbo University - Zhuangshi Campus
        • Contact:
          • Haihang Yu, Site 7030
          • Phone Number: +861360588018
  • Croatia
    • City of Zagreb
      • Zagreb, City of Zagreb, Croatia, 10000
        • Withdrawn
        • Local Institution - 4106
      • Zagreb, City of Zagreb, Croatia, 10000
        • Completed
        • Local Institution - 4102
      • Zagreb, City of Zagreb, Croatia, 10000
        • Completed
        • Local Institution - 4105
      • Zagreb, City of Zagreb, Croatia, 10090
        • Completed
        • Local Institution - 4101
      • Zagreb, City of Zagreb, Croatia, 10090
        • Completed
        • Local Institution - 4104
  • France
      • Toulouse, France, 31059 Cedex 9
        • Withdrawn
        • Local Institution - 2512
      • Toulouse, France, 31059
        • Recruiting
        • CHU de Toulouse- Gerontopole
        • Contact:
          • Maria Eugenia Soto-Martin, Site 2513
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06100
        • Completed
        • Local Institution - 2510
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • Recruiting
        • CHRU de Tours - Hôpital Bretonneau
        • Contact:
          • Thomas Desmidt, Site 2511
          • Phone Number: 0234378952
  • Germany
      • Berlin, Germany, 12163
        • Withdrawn
        • Local Institution - 2406
      • Erbach im Odenwald, Germany, 64711
        • Completed
        • Local Institution - 2404
      • Frankfurt am Main, Germany, 60528
        • Completed
        • Local Institution - 2405
    • Baden-Wurttemberg
      • Böblingen, Baden-Wurttemberg, Germany, 71034
        • Withdrawn
        • Local Institution - 2407
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Completed
        • Local Institution - 2402
  • Greece
      • Thessaloniki, Greece, 546 36
        • Completed
        • Local Institution - 4811
    • Attica
      • Athens, Attica, Greece, 115 26
        • Completed
        • Local Institution - 4803
      • Chaidari, Athens, Attica, Greece, 12462
        • Completed
        • Local Institution - 4802
      • Kalyftaki-N. Kifissia, Attica, Greece, 145 64
        • Completed
        • Local Institution - 4810
    • Irakleio
      • Heraklion, Irakleio, Greece, 71500
        • Recruiting
        • PAGNI-University General Hospital of Heraklion
        • Contact:
          • Ioannis Zaganas, Site 4801
          • Phone Number: +302810394643
  • Hungary
      • Budapest, Hungary, 1083
        • Recruiting
        • Semmelweis Egyetem Pszichiátriai és Pszichoterápiás Klinika
        • Contact:
          • János Réthelyi, Site 4602
          • Phone Number: +3612100336
      • Budapest, Hungary, 1123
        • Recruiting
        • Eszak-budai Szent Janos Centrumkorhaz
        • Contact:
          • Tamás Kurimay, Site 4612
          • Phone Number: +3614584537
    • Baranya
      • Pécs, Baranya, Hungary, 7633
        • Recruiting
        • Psychotech Kft.
        • Contact:
          • Viktor Voros, Site 4601
          • Phone Number: +36203236939
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6720
        • Withdrawn
        • Local Institution - 4610
    • Heves County
      • Gyöngyös, Heves County, Hungary, 3200
        • Recruiting
        • Clinexpert Gyöngyös Kft.
        • Contact:
          • Tibor Kelemen, Site 4611
          • Phone Number: 3637312491
  • India
      • Hyderabad, India, 500034
        • Recruiting
        • Asha Hospital - Hyderabad
        • Contact:
          • Chandrasekhar Kammammettu, Site 7403
          • Phone Number: 888888888
      • Kolkata, India, 700017
        • Recruiting
        • Institute of Neurosciences Kolkata
        • Contact:
          • Hrishikesh Kumar, Site 7404
          • Phone Number: 91987464544
      • Varanasi, India, 211 005
        • Recruiting
        • Deva Institute of Healthcare & Research (DIHR) Pvt Ltd (Deva Institute of Healthcare)
        • Contact:
          • Venu Gopal Jhanwar, Site 7402
          • Phone Number: 8662444999
    • Maharashtra
      • Aurangabad, Maharashtra, India, 431005
        • Not yet recruiting
        • Local Institution - 1-13SNAZL0
        • Contact:
          • Site 1-13SNAZL0
      • Nagpur, Maharashtra, India, 440010
        • Recruiting
        • Central Institute of Behavioural Sciences
        • Contact:
          • Shailesh Pangaonkar, Site 7401
          • Phone Number: +917122548966
    • Punjab
      • Chandigarh, Punjab, India, 160012
        • Recruiting
        • Postgraduate Institute of Medical Education & Research (PGIMER)
        • Contact:
          • Aseem Mehra, Site 7405
          • Phone Number: +8264690790
    • Rajasthan
      • Ajmer, Rajasthan, India, 305001
        • Recruiting
        • Jawaharlal Nehru Medical College, Ajmer
        • Contact:
          • Parth Singh Meena, Site 7406
          • Phone Number: 8118877284
  • Israel
      • Petah Tikva, Israel, 49100
        • Completed
        • Local Institution - 3102
      • Ramat Gan, Israel, 5265601
        • Completed
        • Local Institution - 3104
    • Jerusalem
      • Jerusalem, Jerusalem, Israel, 90000
        • Completed
        • Local Institution - 3101
    • Tel Aviv
      • Ashkelon, Tel Aviv, Israel, 7830604
        • Completed
        • Local Institution - 3103
  • Italy
      • Roma, Italy, 00189
        • Completed
        • Local Institution - 2309
    • Campania
      • Salerno, Campania, Italy, 84131
        • Withdrawn
        • Local Institution - 2325
    • Lazio
      • Rome, Lazio, Italy, 00166
        • Completed
        • Local Institution - 2320
      • Rome, Lazio, Italy, 00161
        • Completed
        • Local Institution - 2322
    • Lombardy
      • Brescia, Lombardy, Italy, 25125
        • Recruiting
        • IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
        • Contact:
          • Stefania Orini, Site 2324
      • Milan, Lombardy, Italy, 20149
        • Completed
        • Local Institution - 2323
    • Piedmont
      • Ponderano (Biella), Piedmont, Italy, 13875
        • Completed
        • Local Institution - 2307
    • Roma
      • Rome, Roma, Italy, 00186
        • Withdrawn
        • Local Institution - 2321
  • Japan
      • Fukuoka, Japan, 815-0082
        • Withdrawn
        • Local Institution - 7515
      • Hiroshima, Japan, 730-0844
        • Recruiting
        • Funairi nou clinic
        • Contact:
          • Tomoko Murakami, Site 7516
      • Kumamoto, Japan, 861-8002
        • Recruiting
        • Yuge Neuropsychiatric Hospital
        • Contact:
          • Masahiro Shono, Site 7524
          • Phone Number: 81-96-338-3838
      • Tatebayashi, Japan, 374-0037
        • Recruiting
        • Tsutsujimental Hospital
        • Contact:
          • Hajime Tabuchi, Site 7523
          • Phone Number: 81276802111
    • Fukuoka
      • Iizuka, Fukuoka, Japan, 820-0014
        • Completed
        • Local Institution - 7503
    • Fukushima
      • Kōriyama, Fukushima, Japan, 963-8052
        • Recruiting
        • Southern Tohoku Medical Clinic
        • Contact:
          • Chikako Kaneko, Site 7525
          • Phone Number: 81249345432
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 006-8555
        • Completed
        • Local Institution - 7522
    • Hyōgo
      • Himeji-Shi, Hyōgo, Japan, 672-8044
        • Recruiting
        • Hyogo Prefectural Harima-Himeji General Medical Center
        • Contact:
          • Kenichi Shimada, Site 7526
    • Ibaraki
      • Toride-shi, Ibaraki, Japan, 302-0004
        • Recruiting
        • Memory Clinic Toride
        • Contact:
          • Youshun Boku, Site 7508
          • Phone Number: +297796166
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760-0065
        • Completed
        • Local Institution - 7514
    • Kanagawa
      • Hadano, Kanagawa, Japan, 257-0003
        • Recruiting
        • Hatano Kousei Hospital
        • Contact:
          • Yoshiro Sakai, Site 7505
          • Phone Number: +81-463-77-1108
      • Kawasaki-Shi, Kanagawa, Japan, 210-0852
        • Recruiting
        • Koukan Clinic
        • Contact:
          • Yasuhiro Yoshii, Site 7507
          • Phone Number: 81443668900
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital
        • Contact:
          • Keiko Ide, Site 7513
          • Phone Number: 81457872800
      • Yokohama, Kanagawa, Japan, 2310801
        • Recruiting
        • Yokohama City Minato Red Cross Hospital
        • Contact:
          • Takuya Ohkubo, Site 7502
          • Phone Number: 0456286100
      • Yokohama, Kanagawa, Japan, 230-0074
        • Completed
        • Local Institution - 7520
    • Kyoto
      • Kyoto, Kyoto, Japan, 616-8255
        • Recruiting
        • National hospital Organization Utano National Hospital
        • Contact:
          • Shinji Sudoh, Site 7511
          • Phone Number: 81-75-461-5121
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-1101
        • Completed
        • Local Institution - 7506
    • Osaka
      • Sakai, Osaka, Japan, 590-0018
        • Recruiting
        • Asakayama General Hospital
        • Contact:
          • Kazue Kamae, Site 7509
          • Phone Number: 0722294882
      • Takatsuki, Osaka, Japan, 569-1041
        • Recruiting
        • Shin-Abuyama Hospital
        • Contact:
          • Kazushige Morimoto, Site 7501
          • Phone Number: 8.1726931881E10
    • Saga-ken
      • Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan, 842-0192
        • Withdrawn
        • Local Institution - 7510
    • Saitama
      • Wako-Shi, Saitama, Japan, 351-0102
        • Completed
        • Local Institution - 7504
    • Tokushima
      • Yoshinogawa, Tokushima, Japan, 776-8585
        • Completed
        • Local Institution - 7512
    • Tokyo
      • Hachiōji, Tokyo, Japan, 193-0811
        • Completed
        • Local Institution - 7518
      • Setagaya-Ku, Tokyo, Japan, 156-0041
        • Recruiting
        • Kurumi Clinic
        • Contact:
          • Chika Nishimura, Site 7519
          • Phone Number: 81333277462
      • Setagaya-Ku, Tokyo, Japan, 154-0004
        • Recruiting
        • Sangenjaya Nakamura Mental Clinic
        • Contact:
          • Satoshi Nakamura, Site 7521
      • Setagaya-Ku, Tokyo, Japan, 156-0057
        • Recruiting
        • Tokyo Metropolitan Matsuzawa Hospital
        • Contact:
          • Kenichi Oshima, Site 7528
          • Phone Number: 81333037211
  • Poland
      • Kielce, Poland, 25-411
        • Withdrawn
        • Local Institution - 4213
      • Lodz, Poland, 91-743
        • Recruiting
        • Pro Salus Sp. z o.o.sp. k
        • Contact:
          • Lukasz Jasek, Site 4214
      • Lodz, Poland, 91-743
        • Withdrawn
        • Local Institution - 7527
      • Lublin, Poland, 20-064
        • Completed
        • Local Institution - 4206
      • Sochaczew, Poland, 96-500
        • Recruiting
        • RCMed Oddzial Sochaczew
        • Contact:
          • Malgorzata Fengler-Czeczko, Site 4216
          • Phone Number: +480607705818
      • Wroclaw, Poland, 50-981
        • Completed
        • Local Institution - 4211
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-485
        • Recruiting
        • Centrum Medyczne HCP Szpital im. Jana Pawla II
        • Contact:
          • Przemyslaw Osip, Site 4210
          • Phone Number: 48604116632
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Recruiting
        • Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
        • Contact:
          • Adam Wlodarczyk, Site 4212
          • Phone Number: 48583493720
    • Warmian-Masurian Voivodeship
      • Iława, Warmian-Masurian Voivodeship, Poland, 14-200
        • Recruiting
        • Osrodek Badan Klinicznych BD Research Sp. z o.o. - Andersa 3
        • Contact:
          • Elzbieta Wagenknecht, Site 4215
      • Iława, Warmian-Masurian Voivodeship, Poland, 14-200
        • Withdrawn
        • Local Institution - 4207
  • Portugal
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
        • Contact:
          • Ana Verdelho, Site 2705
          • Phone Number: 3512178050x50
      • Lisbon, Portugal, 1998-018
        • Withdrawn
        • Local Institution - 2706
    • Braga District
      • Guimarães, Braga District, Portugal, 4835-044
        • Completed
        • Local Institution - 2701
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1349-019
        • Completed
        • Local Institution - 2704
      • Torres Vedras, Lisbon District, Portugal, 2560-280
        • Completed
        • Local Institution - 2702
    • Porto District
      • Matosinhos Municipality, Porto District, Portugal, 4454-509
        • Completed
        • Local Institution - 2703
  • Puerto Rico
      • Bayamón, Puerto Rico, 00961-6910
        • Completed
        • Local Institution - 1303
      • Bayamón, Puerto Rico, 961
        • Completed
        • Local Institution - 1301
      • San Juan, Puerto Rico, 00918-4502
        • Recruiting
        • Instituto De Neurologia Dra. Ivonne Fraga,Psc
        • Contact:
          • Ivonne De L Fraga Berrios, Site 1302
          • Phone Number: 7874035534
      • San Juan, Puerto Rico, 00935
        • Withdrawn
        • Local Institution - 1305
      • San Juan, Puerto Rico, 00926-3160
        • Active, not recruiting
        • Local Institution - 1304
  • Romania
      • Bucharest, Romania, 40874
        • Recruiting
        • Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
        • Contact:
          • Mihaela-Cleopatra Rosca, Site 4906
          • Phone Number: +40745588989
      • Bucharest, Romania, 11241
        • Not yet recruiting
        • Local Institution - 4907
        • Contact:
          • Site 4907
      • Constanța, Romania, 90123
        • Recruiting
        • Cai Ferate Clinical Hospital Constanta
        • Contact:
          • Ana-Maria Ionescu, Site 4902
          • Phone Number: 4024151078x3
      • Craiova, Romania, 200157
        • Recruiting
        • Institutul Privat de Cercetări Melchisedec pentru Boli Autoimune, Ereditare și Rare -I.P.C.M
        • Contact:
          • George Badescu, Site 4903
          • Phone Number: +40762088099
      • Iași, Romania, 700282
        • Withdrawn
        • Local Institution - 4905
      • Sibiu, Romania, 550281
        • Recruiting
        • S.C. Carpe Diem SRL
        • Contact:
          • Cosmina Muntean, Site 4901
          • Phone Number: 4026944141x5
    • Bihor County
      • Oradea, Bihor County, Romania, 410027
        • Recruiting
        • CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie
        • Contact:
          • Elena Daniela Buhas Ramocea, Site 4904
          • Phone Number: 0040747056934
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Military Medical Academy
        • Contact:
          • Smiljana Kostic, Site 4314
          • Phone Number: +381112663470
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Hospital Center Dragisa Misovic Dedinje
        • Contact:
          • Vladimir Diligenski, Site 4306
          • Phone Number: 381637708765
      • Gornja Toponica, Serbia, 705631
        • Active, not recruiting
        • Local Institution - 4312
      • Kovin, Serbia, 26220
        • Completed
        • Local Institution - 4305
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
        • Contact:
          • Vladimir Janjic, Site 4301
          • Phone Number: +38134370208
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Clinical Centre of Vojvodina
        • Contact:
          • Marija Semnic, Site 4309
          • Phone Number: 381184601111
    • Belgrade
      • Belgrade, Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia - Dr Subotica 6 - PPDS
        • Contact:
          • Tanja Stojkovic, Site 4313
          • Phone Number: 381607545958
  • Slovakia
      • Banská Bystrica, Slovakia, 974 04
        • Recruiting
        • MUDr. Beata Dupejova - Neurologicka Ambulancia s.r.o
        • Contact:
          • Beata Dupejova, Site 4401
          • Phone Number: +421484124549
      • Dubnica nad Váhom, Slovakia, 018 41
        • Recruiting
        • KONZILIUM s.r.o
        • Contact:
          • Magdalena Perichtova, Site 4402
          • Phone Number: +421424426231
      • Košice, Slovakia, 040 01
        • Completed
        • Local Institution - 4406
      • Pezinok, Slovakia, 902 18
        • Completed
        • Local Institution - 4407
      • Vranov nad Topľou, Slovakia, 093 01
        • Completed
        • Local Institution - 4403
    • Košice Region
      • Košice, Košice Region, Slovakia, 041 90
        • Recruiting
        • Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
        • Contact:
          • Slavka Dubinska, Site 4405
          • Phone Number: +421903625643
  • South Korea
      • Gangwon-do, South Korea, 200-704
        • Recruiting
        • Hallym University Chuncheon Sacred Heart Hospital
        • Contact:
          • Do-Hoon Kim, Site 7218
          • Phone Number: 821041512959
      • Seoul, South Korea, 4763
        • Recruiting
        • Hanyang university seoul hospital
        • Contact:
          • Hee Jin Kim, Site 7211
          • Phone Number: +82222908374
      • Seoul, South Korea, 06273
        • Recruiting
        • Gangnam Severance Hospital, Yonsei University Health System
        • Contact:
          • Hanna Cho, Site 7219
      • Seoul, South Korea, 07071
        • Recruiting
        • SMG - SNU Boramae Medical Center
        • Contact:
          • Jun-Young Lee, Site 7203
          • Phone Number: 8228702462
      • Seoul, South Korea, 143-729
        • Not yet recruiting
        • Local Institution - 1-14KMN4SY
        • Contact:
          • Site 1-14KMN4SY
    • Gyeonggido
      • Ansan-si, Gyeonggido, South Korea, 15355
        • Completed
        • Local Institution - 7214
      • Yongin-si, Gyeonggido, South Korea, 16995
        • Recruiting
        • Yongin Severance Hospital, Yonsei University Health System
        • Contact:
          • Woo Jung Kim, Site 7216
          • Phone Number: +8218991004
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, South Korea, 07804
        • Recruiting
        • Ewha Womans University Seoul Hospital
        • Contact:
          • Jee Hyang Jeong, Site 7213
          • Phone Number: +821090851927
      • Seoul, Seoul Teugbyeolsi, South Korea, 7985
        • Recruiting
        • Ewha Womans University MokDong Hospital
        • Contact:
          • Geon Ha Kim, Site 7215
          • Phone Number: 82226505298
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Manho Kim, Site 7206
          • Phone Number: +82-2-2072-2193
      • Seoul, Seoul Teugbyeolsi, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Hong Jin Jeon, Site 7210
          • Phone Number: 82234103586
      • Seoul, Seoul Teugbyeolsi, South Korea, 06591
        • Recruiting
        • The Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
          • Dong Woo Kang, Site 7217
          • Phone Number: 82200000000
      • Yeongdeungpo-gu, Seoul Teugbyeolsi, South Korea, 07345
        • Recruiting
        • The Catholic University of Korea, Yeouido St. Mary's Hospital
        • Contact:
          • Hyun-Kook Lim, Site 7212
  • Spain
      • Lleida, Spain, 25198
        • Completed
        • Local Institution - 2212
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clínico San Carlos
        • Contact:
          • Jordi Matias Guiu, Site 2210
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Universitario de Salamanca
        • Contact:
          • Angel Montejo Gonzalez, Site 2204
          • Phone Number: +34923126580
      • Seville, Spain, 41009
        • Recruiting
        • Hospital Victoria Eugenia
        • Contact:
          • Felix Vinuela Fernandez, Site 2201
          • Phone Number: +34654566812
      • Valladolid, Spain, 47012
        • Recruiting
        • Hospital Universitario Rio Hortega
        • Contact:
          • Juan Muñoz Sanchez, Site 2203
          • Phone Number: +34679279973
      • Zaragoza, Spain, 50012
        • Recruiting
        • Hospital Viamed Montecanal
        • Contact:
          • Antonio Oliveros-Cid, Site 2206
          • Phone Number: +34670492099
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro - Majadahonda
        • Contact:
          • Pilar Sanchez Alonso, Site 2211
    • Málaga
      • Málaga, Málaga, Spain, 29004
        • Recruiting
        • Hospital Quironsalud Malaga
        • Contact:
          • Jesus Romero Imbroda, Site 2213
          • Phone Number: 3495194000
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • Hacettepe University Medical Faculty
        • Contact:
          • Gul Yalcin Cakmakli, Site 4706
      • Eskişehir, Turkey (Türkiye), 26040
        • Recruiting
        • Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
        • Contact:
          • Fatma Nazli Durmaz Celik, Site 4701
          • Phone Number: +905069093663
      • Istanbul, Turkey (Türkiye), 34093
        • Recruiting
        • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
        • Contact:
          • Hasmet Ayhan Hanagasi, Site 4704
          • Phone Number: +905322728519
      • Izmir, Turkey (Türkiye), 35340
        • Completed
        • Local Institution - 4705
      • Izmir, Turkey (Türkiye), 35370
        • Completed
        • Local Institution - 4703
    • Samsun
      • Atakum, Samsun, Turkey (Türkiye), 55270
        • Completed
        • Local Institution - 4702
  • Ukraine
      • Khmelnytskyi, Ukraine, 32120
        • Recruiting
        • Municipal NonProfit Enterprise Khmelnytskyi Regional Psychiatric Care Facility of the Khmelnytskyi Regional Council
        • Contact:
          • Viktoriia Kachynska, Site 8003
          • Phone Number: 380672624158
      • Lviv, Ukraine, 79035
        • Not yet recruiting
        • Local Institution - 8006
        • Contact:
          • Site 8006
      • Smila, Ukraine, 20708
        • Recruiting
        • MNE Cherkasy Regional Psychiatric Hospital of Cherkasy RC
        • Contact:
          • Iryna Kosenkova, Site 8004
          • Phone Number: 380473321979
      • Ternopil, Ukraine, 46027
        • Recruiting
        • MNE Ternopil Regional Clinical Psychoneurological Hospital of TRC
        • Contact:
          • Olena Venger, Site 8008
          • Phone Number: +380677565556
      • Uzhhorod, Ukraine, 88000
        • Recruiting
        • Neyromed LLC - Uzhhorod
        • Contact:
          • Oleksandr Romaniv, Site 8005
          • Phone Number: 380509997971
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79053
        • Not yet recruiting
        • Local Institution - 8007
        • Contact:
          • Site 8007
    • Vinnytsia Oblast
      • Vinnytsia, Vinnytsia Oblast, Ukraine, Ukraine
        • Not yet recruiting
        • Local Institution - 8001
        • Contact:
          • Site 8001
      • Vinnytsia, Vinnytsia Oblast, Ukraine, 21005
        • Recruiting
        • MI Vinnytsia Regional Psychoneurological Hospital n.a. acad. O.I. Yushchenko
        • Contact:
          • Oksana Serebrennikova, Site 8002
          • Phone Number: +380679605672
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Completed
        • Local Institution - 1227
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Gilbert Neurology Partners - PLLC - Avacare
        • Contact:
          • Jonathan Hodgson, Site 1247
          • Phone Number: 602-761-9631
      • Phoenix, Arizona, United States, 85006-2528
        • Recruiting
        • Banner Alzheimer's Institute
        • Contact:
          • Ganesh Gopalakrishna, Site 1217
          • Phone Number: 602-839-6900
      • Scottsdale, Arizona, United States, 85260-6742
        • Completed
        • Local Institution - 1220
    • California
      • Anaheim, California, United States, 92805-5854
        • Recruiting
        • Advanced Research Center, Inc.
        • Contact:
          • Steven Macina, Site 1104
          • Phone Number: 714-999-6688
      • Chino, California, United States, 91710
        • Recruiting
        • Inland Psychiatric Medical Group (IPMG)-Chino
        • Contact:
          • Nandita Puchakayala, Site 1244
          • Phone Number: 909-488-9116
      • Long Beach, California, United States, 90805
        • Completed
        • Local Institution - 1230
      • Los Angeles, California, United States, 90095
        • Withdrawn
        • Local Institution - 1219
      • Los Angeles, California, United States, 90033-5313
        • Recruiting
        • USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
        • Contact:
          • Lon Schneider, Site 1226
          • Phone Number: 323-442-3715
      • Orange, California, United States, 92866
        • Completed
        • Local Institution - 1001
      • Orange, California, United States, 92868-2847
        • Completed
        • Local Institution - 1228
      • Pasadena, California, United States, 91106
        • Active, not recruiting
        • Local Institution - 1043
      • Rancho Cucamonga, California, United States, 91730
        • Active, not recruiting
        • Local Institution - 1213
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • Recruiting
        • University of Connecticut Health Center
        • Contact:
          • Neha Jain, Site 1222
          • Phone Number: 860-790-7354
    • Florida
      • Atlantis, Florida, United States, 33462
        • Completed
        • Local Institution - 1225
      • Bonita Springs, Florida, United States, 34134
        • Recruiting
        • Envision Trials LLC
        • Contact:
          • Daniel Mandri, Site 1020
          • Phone Number: 305-819-2909
      • Cutler Bay, Florida, United States, 33189-1230
        • Active, not recruiting
        • Local Institution - 1138
      • Daytona Beach, Florida, United States, 32117-5532
        • Recruiting
        • Arrow Clinical Trials
        • Contact:
          • David Billmeier, Site 1023
          • Phone Number: 386-278-8000
      • Deerfield Beach, Florida, United States, 33442
        • Completed
        • Local Institution - 1224
      • Doral, Florida, United States, 33122-1620
        • Active, not recruiting
        • Local Institution - 1164
      • Gulf Breeze, Florida, United States, 32561
        • Not yet recruiting
        • Local Institution - 1264
        • Contact:
          • Site 1264
      • Hialeah, Florida, United States, 33012-4648
        • Active, not recruiting
        • Local Institution - 1120
      • Hialeah, Florida, United States, 33013
        • Completed
        • Local Institution - 1237
      • Homestead, Florida, United States, 33030
        • Active, not recruiting
        • Local Institution - 1229
      • Lady Lake, Florida, United States, 32159
        • Completed
        • Local Institution - 1040
      • Miami, Florida, United States, 33165-3947
        • Active, not recruiting
        • Local Institution - 1129
      • Miami, Florida, United States, 33173
        • Active, not recruiting
        • Local Institution - 1111
      • Miami, Florida, United States, 33137
        • Completed
        • Local Institution - 1010
      • Miami, Florida, United States, 33175
        • Completed
        • Local Institution - 1158
      • Miami, Florida, United States, 33122-1335
        • Active, not recruiting
        • Local Institution - 1021
      • Miami, Florida, United States, 33135
        • Active, not recruiting
        • Local Institution - 1115
      • Miami, Florida, United States, 33173-1474
        • Active, not recruiting
        • Local Institution - 1006
      • Miami, Florida, United States, 33032
        • Active, not recruiting
        • Local Institution - 1159
      • Miami, Florida, United States, 33135-1601
        • Active, not recruiting
        • Local Institution - 1125
      • Miami, Florida, United States, 33155-6630
        • Active, not recruiting
        • Local Institution - 1113
      • Miami, Florida, United States, 33165
        • Active, not recruiting
        • Local Institution - 1150
      • Miami, Florida, United States, 33184-1412
        • Active, not recruiting
        • Local Institution - 1157
      • Miami, Florida, United States, 33145-2455
        • Completed
        • Local Institution - 1143
      • Miami, Florida, United States, 33179-2537
        • Completed
        • Local Institution - 1105
      • Miami, Florida, United States, 33135-2968
        • Active, not recruiting
        • Local Institution - 1236
      • Miami, Florida, United States, 33176-1451
        • Completed
        • Local Institution - 1235
      • Miami, Florida, United States, 33176-7947
        • Completed
        • Local Institution - 1147
      • Miami, Florida, United States, 33176
        • Active, not recruiting
        • Local Institution - 1234
      • Miami Gardens, Florida, United States, 33056-4000
        • Active, not recruiting
        • Local Institution - 1126
      • Miami Lakes, Florida, United States, 33014
        • Completed
        • Local Institution - 1209
      • Miami Lakes, Florida, United States, 33016
        • Active, not recruiting
        • Local Institution - 1118
      • Naples, Florida, United States, 34105
        • Recruiting
        • Aqualane Clinical Research
        • Contact:
          • William Justiz, Site 1246
          • Phone Number: 941-436-6838
      • Ocoee, Florida, United States, 34761-2964
        • Recruiting
        • Sensible Healthcare, LLC
        • Contact:
          • Kelly Taylor, Site 1212
          • Phone Number: 407-654-2724
      • Orlando, Florida, United States, 32807-3555
        • Recruiting
        • Combined Research Orlando Phase I-IV LLC
        • Contact:
          • Eric Carbonell, Site 1112
          • Phone Number: 407-440-4493
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Nova Psychiatry
        • Contact:
          • David Medina, Site 1242
          • Phone Number: 407-823-8421
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Charter Research Orlando
        • Contact:
          • Diana Balsalobre, Site 1257
      • Ormond Beach, Florida, United States, 32174-3101
        • Active, not recruiting
        • Local Institution - 1204
      • Port Orange, Florida, United States, 32127-5169
        • Active, not recruiting
        • Local Institution - 1205
      • Sweetwater, Florida, United States, 33182
        • Completed
        • Local Institution - 1133
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Guardian Angel Research
        • Contact:
          • Sadaf Bazargan, Site 1124
          • Phone Number: 813-300-3300
      • Tampa, Florida, United States, 33629-5837
        • Recruiting
        • Interventional Psychiatry of Tampa Bay
        • Contact:
          • Jamie Fernandez, Site 1110
          • Phone Number: 813-251-1800
      • Tampa, Florida, United States, 33614-2869
        • Active, not recruiting
        • Local Institution - 1123
      • The Villages, Florida, United States, 32162-2698
        • Recruiting
        • Charter Research
        • Contact:
          • Jeffrey Norton, Site 1256
          • Phone Number: 352-775-1000
      • Wellington, Florida, United States, 33414
        • Withdrawn
        • Local Institution - 1233
      • West Palm Beach, Florida, United States, 33407-3209
        • Recruiting
        • Premiere Research Institute at Palm Beach Neurology, PA
        • Contact:
          • Paul Winner, Site 1216
          • Phone Number: 561-845-0500
    • Georgia
      • Atlanta, Georgia, United States, 30328-5532
        • Recruiting
        • AGILE Clinical Research Trials, LLC
        • Contact:
          • Vasundhara Cheekati, Site 1206
          • Phone Number: 404-382-8660
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478-1064
        • Recruiting
        • McLean Hospital
        • Contact:
          • Arkadiy Stolyar, Site 1223
          • Phone Number: 617-855-2136
      • Boston, Massachusetts, United States, 02111-1552
        • Recruiting
        • Tufts Medical Center - 800 Washington St - PPDS
        • Contact:
          • Brent Forester, Site 1245
          • Phone Number: 617-636-3202
      • North Dartmouth, Massachusetts, United States, 02747-2612
        • Recruiting
        • Boston Neuro Research Center
        • Contact:
          • Mushtaque Chachar, Site 1243
          • Phone Number: 508-925-7403
      • South Dartmouth, Massachusetts, United States, 02747
        • Completed
        • Local Institution - 1250
      • Springfield, Massachusetts, United States, 01103
        • Recruiting
        • Elixia Health - Springfield - Elixia - PPDS
        • Contact:
          • Susan Smiga, Site 1239
          • Phone Number: 413-305-1142
    • Michigan
      • Bloomfield Township, Michigan, United States, 48302-1909
        • Recruiting
        • Neurobehavioral Medicine Group (NBMG)
        • Contact:
          • Richard Jackson, Site 1248
          • Phone Number: 412-916-2425
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Precise Research Centers
        • Contact:
          • Joseph Kwentus, Site 1132
          • Phone Number: 601-420-5810
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Recruiting
        • Tekton Research, LLC - Saint Louis Psychiatry - PPDS
        • Contact:
          • Ernest Graypel, Site 1255
          • Phone Number: 314-594-7785
    • New Jersey
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Advanced Memory Research Institute - CenExel - PPDS
        • Contact:
          • Arun Singh, Site 1202
          • Phone Number: 732-341-9500
      • Toms River, New Jersey, United States, 08755
        • Active, not recruiting
        • Local Institution - 1232
    • New York
      • New Windsor, New York, United States, 12553-7754
        • Recruiting
        • Mid Hudson Medical Research PLLC
        • Contact:
          • Sashi Makam, Site 1251
          • Phone Number: 845-674-9398
      • Syracuse, New York, United States, 13210-2306
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:
          • Tinatin Chabrashvili, Site 1240
          • Phone Number: 617-636-5000
      • Syracuse, New York, United States, 13203
        • Withdrawn
        • Local Institution - 1231
      • Woodmere, New York, United States, 11598-1739
        • Recruiting
        • Five Towns Neurology, PC
        • Contact:
          • David Steiner, Site 1025
          • Phone Number: 516-239-1800
    • North Carolina
      • Greensboro, North Carolina, United States, 27410-3311
        • Recruiting
        • Triad Clinical Trials - 515 College Rd
        • Contact:
          • Richard Montgomery, Site 1221
          • Phone Number: 336-235-0991
      • Matthews, North Carolina, United States, 28105-8336
        • Recruiting
        • AMC Research, LLC - Flourish - PPDS
        • Contact:
          • Mohammad Bolouri, Site 1214
          • Phone Number: 704-364-4000
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • West Clinical Research
        • Contact:
          • Patrick Morgante, Site 1215
          • Phone Number: 252-515-0050
      • Morehead City, North Carolina, United States, 28557
        • Withdrawn
        • Local Institution - 5005
      • Shelby, North Carolina, United States, 28150-3803
        • Withdrawn
        • Local Institution - 1252
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Recruiting
        • Ohio State University
        • Contact:
          • Douglas Scharre, Site 1201
          • Phone Number: 614-293-4560
      • Dayton, Ohio, United States, 45417-3445
        • Not yet recruiting
        • Local Institution - 1258
        • Contact:
          • Site 1258
      • Independence, Ohio, United States, 44131
        • Recruiting
        • Insight Clinical Trials LLC - Independence
        • Contact:
          • Mark Stillman, Site 1249
          • Phone Number: 216-444-8897
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • The Rivus Wellness & Research Institute
        • Contact:
          • Marvin Peyton, Site 1016
          • Phone Number: 405-317-5783
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
        • Contact:
          • Chuang-Kuo Wu, Site 1218
          • Phone Number: 714-456-7002
    • Tennessee
      • Nashville, Tennessee, United States, 37212-3133
        • Recruiting
        • Vanderbilt Psychiatric Hospital
        • Contact:
          • Jo Wilson, Site 1211
          • Phone Number: 615-322-4967
    • Texas
      • Austin, Texas, United States, 78757-7566
        • Recruiting
        • Senior Adults Specialty Research
        • Contact:
          • John Bertelson, Site 1263
          • Phone Number: 512-407-8628
      • Dallas, Texas, United States, 75231-6079
        • Not yet recruiting
        • Local Institution - 1260
        • Contact:
          • Site 1260
      • DeSoto, Texas, United States, 75115-2043
        • Recruiting
        • Epic Medical Research LLC - DeSoto
        • Contact:
          • Haresh Boghara, Site 1121
          • Phone Number: 972-777-6956
      • El Paso, Texas, United States, 79912-1743
        • Recruiting
        • Advanced Neuro Research Center - El Paso
        • Contact:
          • Aamr Herekar, Site 1208
          • Phone Number: 915-974-2200
      • Fort Worth, Texas, United States, 76104-4143
        • Not yet recruiting
        • Local Institution - 1262
        • Contact:
          • Site 1262
      • Houston, Texas, United States, 77030-1312
        • Not yet recruiting
        • Local Institution - 1261
        • Contact:
          • Site 1261
      • Irving, Texas, United States, 75062-2898
        • Recruiting
        • University Hills Clinical Research - 102 Decker Ct
        • Contact:
          • Mary Ann Knesevich, Site 1259
          • Phone Number: 972-717-6262
      • Plano, Texas, United States, 75093-8225
        • Completed
        • Local Institution - 1238
      • San Antonio, Texas, United States, 78229-3901
        • Recruiting
        • Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
        • Contact:
          • Antonio Teixeira, Site 1210
          • Phone Number: 210-567-8229
      • Stafford, Texas, United States, 77477-3929
        • Completed
        • Local Institution - 1134
    • Virginia
      • Vienna, Virginia, United States, 22182
        • Recruiting
        • Conquest Research, LLC - Virginia - Vienna
        • Contact:
          • Henry Tran, Site 1241
          • Phone Number: 703-717-7755
    • Washington
      • Bellevue, Washington, United States, 98007-4879
        • Recruiting
        • Northwest Clinical Research Center
        • Contact:
          • Wisam Al Jumaili, Site 1253
          • Phone Number: 425-453-0404
      • Kirkland, Washington, United States, 98034
        • Withdrawn
        • Local Institution - 1254

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Patients who are 55 to 90 years of age, inclusive, at the time of Screening (Visit 1).
  • Patients who are diagnosed with AD based on the 2024 revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
  • Patient must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma.
  • Patient must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation).

Exclusion Criteria

- Patients will not be able to participate if they have:

i) Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features.

ii) History of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder.

iii) Patients are not able to participate if they have certain safety concerns, including certain laboratory test irregularities.

* 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Placebo
Specified dose on specified days
Experimental: KarXT
Drug: KarXT
Specified dose on specified days
Other Names:
  • BMS-986510

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Time Frame: Up to Week 14
Up to Week 14

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale
Time Frame: Up to Week 14
Up to Week 14
Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain
Time Frame: Up to Week 14
Up to Week 14
Change from baseline in NPI-C Core score: Delusion Domain
Time Frame: Up to Week 14
Up to Week 14
Change from baseline in NPI-C Core score: Agitation Domain
Time Frame: Up to Week 14
Up to Week 14
Change from baseline in NPI-C Core score: Aggression Domain
Time Frame: Up to Week 14
Up to Week 14
Change from baseline in NPI-C Agitation score
Time Frame: Up to Week 14
Up to Week 14
Change from baseline in NPI-C Core score: Caregiver Distress Scale
Time Frame: Up to Week 14
Up to Week 14
Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score
Time Frame: Up to Week 14
Up to Week 14
Number of participants with Adverse Events (AEs)
Time Frame: Up to Week 14
Up to Week 14
Number of participants with Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 14
Up to Week 14
Number of participants with Serious Adverse Events (SAEs)
Time Frame: Up to Week 14
Up to Week 14
Number of participants with TEAEs leading to study withdrawal
Time Frame: Up to Week 14
Up to Week 14
Number of participants with procholinergic symptoms
Time Frame: Up to Week 14
Up to Week 14
Number of participants with anticholinergic symptoms
Time Frame: Up to Week 14
Up to Week 14
Number of participants with AEs of Special Interest (AESIs)
Time Frame: Up to Week 14
Up to Week 14
Barnes Akathisia Rating Scale (BARS) Score
Time Frame: Up to Week 14
Up to Week 14
Abnormal Involuntary Movement Scale (AIMS) Score
Time Frame: Up to Week 14
Up to Week 14
Body Weight
Time Frame: Up to Week 14
Up to Week 14
Body Mass Index (BMI)
Time Frame: Up to Week 14
Up to Week 14
Number of participants with vital sign abnormalities
Time Frame: Up to Week 14
Up to Week 14
Number of participants with clinical laboratory abnormalities
Time Frame: Up to Week 14
Up to Week 14
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time Frame: Up to Week 14
Up to Week 14
Cognition as assessed by the Mini-Mental State Examination (MMSE)
Time Frame: Up to Week 14
Up to Week 14
Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13)
Time Frame: Up to Week 14
Up to Week 14
International Prostate Symptom Score (IPSS)
Time Frame: Up to Week 14
Up to Week 14
Number of participants with suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to Week 14
Up to Week 14

Collaborators and Investigators

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

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Collaborators

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Investigators

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

Publications and helpful links

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

Helpful Links

Study record dates

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

Study Major Dates

Study Start (Actual)

September 26, 2024

Primary Completion (Estimated)

November 24, 2026

Study Completion (Estimated)

December 22, 2026

Study Registration Dates

First Submitted

August 30, 2024

First Submitted That Met QC Criteria

August 30, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 25, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0056
  • 2024-516363-92 (Other Identifier: EU CTR)
  • U1111-1310-4139 (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

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

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