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A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
55 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
406
Start Date
2024-09-26
Completion Date
2026-12-22
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
KarXT
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (292)
Local Institution - 1227
Chandler, Arizona, United States
Gilbert Neurology Partners - PLLC - Avacare
Gilbert, Arizona, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
Local Institution - 1220
Scottsdale, Arizona, United States
Advanced Research Center, Inc.
Anaheim, California, United States
Inland Psychiatric Medical Group (IPMG)-Chino
Chino, California, United States
Local Institution - 1230
Long Beach, California, United States
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
Los Angeles, California, United States
Local Institution - 1219
Los Angeles, California, United States
Local Institution - 1001
Orange, California, United States
Local Institution - 1228
Orange, California, United States
Local Institution - 1043
Pasadena, California, United States
Local Institution - 1213
Rancho Cucamonga, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Local Institution - 1225
Atlantis, Florida, United States
Envision Trials LLC
Bonita Springs, Florida, United States
Local Institution - 1138
Cutler Bay, Florida, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
Local Institution - 1224
Deerfield Beach, Florida, United States
Local Institution - 1164
Doral, Florida, United States
Local Institution - 1264
Gulf Breeze, Florida, United States
Local Institution - 1120
Hialeah, Florida, United States
Local Institution - 1237
Hialeah, Florida, United States
Local Institution - 1229
Homestead, Florida, United States
Local Institution - 1040
Lady Lake, Florida, United States
Local Institution - 1159
Miami, Florida, United States
Local Institution - 1021
Miami, Florida, United States
Local Institution - 1125
Miami, Florida, United States
Local Institution - 1236
Miami, Florida, United States
Local Institution - 1115
Miami, Florida, United States
Local Institution - 1010
Miami, Florida, United States
Local Institution - 1143
Miami, Florida, United States
Local Institution - 1113
Miami, Florida, United States
Local Institution - 1129
Miami, Florida, United States
Local Institution - 1150
Miami, Florida, United States
Local Institution - 1006
Miami, Florida, United States
Local Institution - 1111
Miami, Florida, United States
Local Institution - 1158
Miami, Florida, United States
Local Institution - 1235
Miami, Florida, United States
Local Institution - 1147
Miami, Florida, United States
Local Institution - 1234
Miami, Florida, United States
Local Institution - 1105
Miami, Florida, United States
Local Institution - 1157
Miami, Florida, United States
Local Institution - 1126
Miami Gardens, Florida, United States
Local Institution - 1209
Miami Lakes, Florida, United States
Local Institution - 1118
Miami Lakes, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Sensible HealthCare, LLC
Ocoee, Florida, United States
Local Institution - 1257
Orlando, Florida, United States
Nova Psychiatry
Orlando, Florida, United States
Combined Research Orlando Phase I-IV LLC
Orlando, Florida, United States
Local Institution - 1204
Ormond Beach, Florida, United States
Local Institution - 1205
Port Orange, Florida, United States
Local Institution - 1133
Sweetwater, Florida, United States
Local Institution - 1123
Tampa, Florida, United States
Guardian Angel Research
Tampa, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Charter Research
The Villages, Florida, United States
Local Institution - 1233
Wellington, Florida, United States
Premiere Research Institute at Palm Beach Neurology, PA
West Palm Beach, Florida, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
McLean Hospital
Belmont, Massachusetts, United States
Tufts Medical Center - 800 Washington St - PPDS
Boston, Massachusetts, United States
Boston Neuro Research Center
North Dartmouth, Massachusetts, United States
Local Institution - 1250
South Dartmouth, Massachusetts, United States
Elixia Health - Springfield - Elixia - PPDS
Springfield, Massachusetts, United States
Neurobehavioral Medicine Group (NBMG)
Bloomfield Township, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
Local Institution - 1255
St Louis, Missouri, United States
Advanced Memory Research Institute - CenExel - PPDS
Toms River, New Jersey, United States
Local Institution - 1232
Toms River, New Jersey, United States
Mid Hudson Medical Research PLLC
New Windsor, New York, United States
Local Institution - 1231
Syracuse, New York, United States
Local Institution - 1240
Syracuse, New York, United States
Five Towns Neurology, PC
Woodmere, New York, United States
Triad Clinical Trials - 515 College Rd
Greensboro, North Carolina, United States
AMC Research, LLC - Flourish - PPDS
Matthews, North Carolina, United States
Local Institution - 5005
Morehead City, North Carolina, United States
West Clinical Research
Morehead City, North Carolina, United States
Local Institution - 1252
Shelby, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Local Institution - 1258
Dayton, Ohio, United States
Insight Clinical Trials LLC - Independence
Independence, Ohio, United States
The Rivus Wellness & Research Institute
Oklahoma City, Oklahoma, United States
Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
Providence, Rhode Island, United States
Vanderbilt Psychiatric Hospital
Nashville, Tennessee, United States
Local Institution - 1263
Austin, Texas, United States
Local Institution - 1260
Dallas, Texas, United States
Epic Medical Research LLC - DeSoto - HyperCore - PPDS
DeSoto, Texas, United States
Advanced Neuro Research Center - El Paso
El Paso, Texas, United States
Local Institution - 1262
Fort Worth, Texas, United States
Local Institution - 1261
Houston, Texas, United States
Local Institution - 1259
Irving, Texas, United States
Local Institution - 1238
Plano, Texas, United States
Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
San Antonio, Texas, United States
Local Institution - 1134
Stafford, Texas, United States
Conquest Research, LLC - Virginia - Vienna
Vienna, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Local Institution - 1254
Kirkland, Washington, United States
CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Fundación para el Estudio y Tratamiento de Enfermedades mentales- FETEM
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, Santa Fe Province, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Organización Médica de Investigación
Buenos Aires, Argentina
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
Buenos Aires, Argentina
Centro Especializado en Neurociencias - CEN
Córdoba, Argentina
Instituto Privado Kremer
Córdoba, Argentina
Local Institution - 2806
Jette, Brussels Capital, Belgium
Local Institution - 2803
Roeselare, West-Vlaanderen, Belgium
Local Institution - 2804
Alken, Belgium
Local Institution - 2807
Bruges, Belgium
Local Institution - 2805
Kortrijk, Belgium
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
Brasília, Federal District, Brazil
CPQuali Pesquisa Clínica Sao Paulo
São Paulo, São Paulo, Brazil
BR Trials - Pesquisa Clínica
São Paulo, São Paulo, Brazil
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, São Paulo, Brazil
Clinilive
São Paulo, São Paulo, Brazil
Ruschel Medicina
Rio de Janeiro, Brazil
Instituto de Psiquiatria HC FMUSP
São Paulo, Brazil
Local Institution - 4506
Sofia, Sofia-Grad, Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd
Plovdiv, Bulgaria
University Multiprofile Hospital For Active Treatment Kanev AD
Rousse, Bulgaria
Medical Center Medika 2005 - Branch Sofia
Sofia, Bulgaria
Local Institution - 4510
Sofia, Bulgaria
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Local Institution - 7005
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Local Institution - 7008
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Shenzhen Kangning Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Nanjing Medical University - Main Campus
Nanjing, Jiangsu, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Local Institution - 7029
Xi'an, Shan1xi, China
Shanghai Mental Health Center - PPDS
Shanghai, Shanghai Municipality, China
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China
Local Institution - 7026
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Tianjin Anding Hospital(Tianjin mental Health Center)
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qiantang Campus
Hangzhou, Zhejiang, China
Zhejiang Hospital - Lingyin Campus
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Local Institution - 7030
Ningbo, Zhejiang, China
Xiangya Hospital Central South University
Changsha, China
First Affiliated Hospital of Kunming Medical University
Kunming, China
Local Institution - 4102
Zagreb, City of Zagreb, Croatia
Local Institution - 4105
Zagreb, City of Zagreb, Croatia
Local Institution - 4106
Zagreb, City of Zagreb, Croatia
Local Institution - 4101
Zagreb, City of Zagreb, Croatia
Local Institution - 4104
Zagreb, City of Zagreb, Croatia
Local Institution - 2510
Nice, Alpes-Maritimes, France
CHRU de Tours - Hôpital Bretonneau
Tours, Indre-et-Loire, France
Local Institution - 2512
Toulouse, France
CHU de Toulouse- Gerontopole
Toulouse, France
Local Institution - 2407
Böblingen, Baden-Wurttemberg, Germany
Local Institution - 2402
Homburg, Saarland, Germany
Local Institution - 2406
Berlin, Germany
Local Institution - 2404
Erbach im Odenwald, Germany
Local Institution - 2405
Frankfurt am Main, Germany
Local Institution - 4803
Athens, Attica, Greece
Local Institution - 4802
Chaidari, Athens, Attica, Greece
Local Institution - 4810
Kalyftaki-N. Kifissia, Attica, Greece
PAGNI-University General Hospital of Heraklion
Heraklion, Irakleio, Greece
Local Institution - 4811
Thessaloniki, Greece
Psychotech Kft.
Pécs, Baranya, Hungary
Local Institution - 4610
Szeged, Csongrád megye, Hungary
Clinexpert Gyöngyös Kft.
Gyöngyös, Heves County, Hungary
Semmelweis Egyetem Pszichiátriai és Pszichoterápiás Klinika
Budapest, Hungary
Eszak-budai Szent Janos Centrumkorhaz
Budapest, Hungary
Local Institution - 1-13SNAZL0
Aurangabad, Maharashtra, India
Central Institute of Behavioural Sciences
Nagpur, Maharashtra, India
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, Punjab, India
Local Institution - 7406
Ajmer, Rajasthan, India
Asha Hospital - Hyderabad
Hyderabad, India
Institute of Neurosciences Kolkata
Kolkata, India
Deva Institute of Healthcare & Research (DIHR) Pvt Ltd (Deva Institute of Healthcare)
Varanasi, India
Local Institution - 3101
Jerusalem, Jerusalem, Israel
Local Institution - 3103
Ashkelon, Tel Aviv, Israel
Local Institution - 3102
Petah Tikva, Israel
Local Institution - 3104
Ramat Gan, Israel
Local Institution - 2325
Salerno, Campania, Italy
Local Institution - 2322
Rome, Lazio, Italy
Local Institution - 2320
Rome, Lazio, Italy
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Brescia, Lombardy, Italy
Local Institution - 2323
Milan, Lombardy, Italy
Local Institution - 2307
Ponderano (Biella), Piedmont, Italy
Local Institution - 2321
Rome, Roma, Italy
Local Institution - 2309
Roma, Italy
Local Institution - 7503
Iizuka, Fukuoka, Japan
Southern TOHOKU Medical Clinic
Kōriyama, Fukushima, Japan
Local Institution - 7522
Sapporo, Hokkaido, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
Himeji-Shi, Hyōgo, Japan
Memory Clinic Toride
Toride-shi, Ibaraki, Japan
Local Institution - 7514
Takamatsu, Kagawa-ken, Japan
Hatano Kousei Hospital
Hadano, Kanagawa, Japan
Koukan Clinic
Kawasaki-Shi, Kanagawa, Japan
Local Institution - 7520
Yokohama, Kanagawa, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
National Hospital Organization Utano National Hospital
Kyoto, Kyoto, Japan
Local Institution - 7506
Tsu, Mie-ken, Japan
Asakayama General Hospital
Sakai, Osaka, Japan
Shin-Abuyama Hospital
Takatsuki, Osaka, Japan
Local Institution - 7510
Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan
Local Institution - 7504
Wako-Shi, Saitama, Japan
Local Institution - 7512
Yoshinogawa, Tokushima, Japan
Local Institution - 7518
Hachiōji, Tokyo, Japan
Sangenjaya Nakamura Mental Clinic
Setagaya-Ku, Tokyo, Japan
Kurumi Clinic
Setagaya-Ku, Tokyo, Japan
Tokyo Metropolitan Matsuzawa Hospital
Setagaya-Ku, Tokyo, Japan
Local Institution - 7515
Fukuoka, Japan
Funairi nou clinic
Hiroshima, Japan
Yuge Neuropsychiatric Hospital
Kumamoto, Japan
Tsutsujimental Hospital
Tatebayashi, Japan
Centrum Medyczne HCP Szpital im. Jana Pawla II
Poznan, Greater Poland Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 4207
Iława, Warmian-Masurian Voivodeship, Poland
Osrodek Badan Klinicznych BD Research Sp. z o.o. - Andersa 3
Iława, Warmian-Masurian Voivodeship, Poland
Local Institution - 4213
Kielce, Poland
Local Institution - 7527
Lodz, Poland
Pro Salus Sp. z o.o.sp. k
Lodz, Poland
Local Institution - 4206
Lublin, Poland
Local Institution - 4216
Sochaczew, Poland
Local Institution - 4211
Wroclaw, Poland
Local Institution - 2701
Guimarães, Braga District, Portugal
Local Institution - 2704
Lisbon, Lisbon District, Portugal
Local Institution - 2702
Torres Vedras, Lisbon District, Portugal
Local Institution - 2703
Matosinhos Municipality, Porto District, Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
Lisbon, Portugal
Local Institution - 2706
Lisbon, Portugal
Local Institution - 1303
Bayamón, Puerto Rico
Local Institution - 1301
Bayamón, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga,Psc
San Juan, Puerto Rico
Local Institution - 1304
San Juan, Puerto Rico
Local Institution - 1305
San Juan, Puerto Rico
CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie
Oradea, Bihor County, Romania
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
Bucharest, Romania
Cai Ferate Clinical Hospital Constanta
Constanța, Romania
Institutul Privat de Cercetări Melchisedec pentru Boli Autoimune, Ereditare și Rare -I.P.C.M
Craiova, Romania
Local Institution - 4905
Iași, Romania
S.C. Carpe Diem SRL
Sibiu, Romania
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
Belgrade, Belgrade, Serbia
Clinical Hospital Center Dragisa Misovic Dedinje
Belgrade, Serbia
Military Medical Academy
Belgrade, Serbia
Military Medical Academy
Belgrade, Serbia
Local Institution - 4312
Gornja Toponica, Serbia
Local Institution - 4305
Kovin, Serbia
University Clinical Center Kragujevac
Kragujevac, Serbia
Clinical Centre of Vojvodina
Novi Sad, Serbia
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
Košice, Košice Region, Slovakia
MUDr. Beata Dupejova - Neurologicka Ambulancia s.r.o
Banská Bystrica, Slovakia
KONZILIUM s.r.o
Dubnica nad Váhom, Slovakia
Local Institution - 4406
Košice, Slovakia
Local Institution - 4407
Pezinok, Slovakia
Local Institution - 4403
Vranov nad Topľou, Slovakia
Local Institution - 7214
Ansan-si, Gyeonggido, South Korea
Yongin Severance Hospital, Yonsei University Health System
Yongin-si, Gyeonggido, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Ewha Womans University Seoul Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Ewha Womans University Mokdong Hospital
Seoul, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Yeouido St. Mary's Hospital
Yeongdeungpo-gu, Seoul Teugbyeolsi, South Korea
Hallym University Chuncheon Sacred Heart Hospital
Gangwon-do, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
SMG - SNU Boramae Medical Center
Seoul, South Korea
Local Institution - 1-14KMN4SY
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
Hospital Quironsalud Malaga
Málaga, Málaga, Spain
Local Institution - 2212
Lleida, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Universitario De Salamanca
Salamanca, Spain
Hospital Victoria Eugenia
Seville, Spain
Hospital Universitario Rio Hortega
Valladolid, Spain
Hospital Viamed Montecanal
Zaragoza, Spain
Local Institution - 4702
Atakum, Samsun, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, Turkey (Türkiye)
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
Eskişehir, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, Turkey (Türkiye)
Local Institution - 4705
Izmir, Turkey (Türkiye)
Local Institution - 4703
Izmir, Turkey (Türkiye)
Local Institution - 8007
Lviv, Lviv Oblast, Ukraine
MI Vinnytsia Regional Psychoneurological Hospital n.a. acad. O.I. Yushchenko
Vinnytsia, Vinnytsia Oblast, Ukraine
Local Institution - 8001
Vinnytsia, Vinnytsia Oblast, Ukraine
Local Institution - 8003
Khmelnytskyi, Ukraine
Local Institution - 8006
Lviv, Ukraine
Local Institution - 8004
Smila, Ukraine
Local Institution - 8008
Ternopil, Ukraine
Neyromed LLC - Uzhhorod
Uzhhorod, Ukraine