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
Status: Recruiting
Location: See all (296) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: f
View:
• 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).
Locations
United States
Arizona
Local Institution - 1227
COMPLETED
Chandler
Gilbert Neurology Partners - PLLC - Avacare
RECRUITING
Gilbert
Banner Alzheimer's Institute
RECRUITING
Phoenix
Local Institution - 1220
COMPLETED
Scottsdale
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
Inland Psychiatric Medical Group (IPMG)-Chino
RECRUITING
Chino
Local Institution - 1230
COMPLETED
Long Beach
Local Institution - 1219
WITHDRAWN
Los Angeles
USC - The Memory and Aging Center (MAC) - Alzheimer Disease Research Center (ADRC)
RECRUITING
Los Angeles
Local Institution - 1001
COMPLETED
Orange
Local Institution - 1228
COMPLETED
Orange
Local Institution - 1043
ACTIVE_NOT_RECRUITING
Pasadena
Local Institution - 1213
ACTIVE_NOT_RECRUITING
Rancho Cucamonga
Connecticut
University of Connecticut Health Center
RECRUITING
Farmington
Florida
Local Institution - 1225
COMPLETED
Atlantis
Envision Trials LLC
RECRUITING
Bonita Springs
Local Institution - 1138
ACTIVE_NOT_RECRUITING
Cutler Bay
Arrow Clinical Trials
RECRUITING
Daytona Beach
Local Institution - 1224
COMPLETED
Deerfield Beach
Local Institution - 1164
ACTIVE_NOT_RECRUITING
Doral
Local Institution - 1264
NOT_YET_RECRUITING
Gulf Breeze
Local Institution - 1120
ACTIVE_NOT_RECRUITING
Hialeah
Local Institution - 1237
COMPLETED
Hialeah
Local Institution - 1229
ACTIVE_NOT_RECRUITING
Homestead
Local Institution - 1040
COMPLETED
Lady Lake
Local Institution - 1006
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1010
COMPLETED
Miami
Local Institution - 1021
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1105
COMPLETED
Miami
Local Institution - 1111
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1113
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1115
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1125
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1129
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1143
COMPLETED
Miami
Local Institution - 1147
COMPLETED
Miami
Local Institution - 1150
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1157
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1158
COMPLETED
Miami
Local Institution - 1159
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1234
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1235
COMPLETED
Miami
Local Institution - 1236
ACTIVE_NOT_RECRUITING
Miami
Local Institution - 1126
ACTIVE_NOT_RECRUITING
Miami Gardens
Local Institution - 1118
ACTIVE_NOT_RECRUITING
Miami Lakes
Local Institution - 1209
COMPLETED
Miami Lakes
Aqualane Clinical Research
RECRUITING
Naples
Sensible HealthCare, LLC
RECRUITING
Ocoee
Charter Research Orlando
RECRUITING
Orlando
Combined Research Orlando Phase I-IV LLC
RECRUITING
Orlando
Nova Psychiatry
RECRUITING
Orlando
Local Institution - 1204
ACTIVE_NOT_RECRUITING
Ormond Beach
Local Institution - 1205
ACTIVE_NOT_RECRUITING
Port Orange
Local Institution - 1133
COMPLETED
Sweetwater
Guardian Angel Research
RECRUITING
Tampa
Interventional Psychiatry of Tampa Bay
RECRUITING
Tampa
Local Institution - 1123
ACTIVE_NOT_RECRUITING
Tampa
Charter Research
RECRUITING
The Villages
Local Institution - 1233
WITHDRAWN
Wellington
Premiere Research Institute at Palm Beach Neurology, PA
RECRUITING
West Palm Beach
Georgia
Agile Clinical Research Trials, LLC
RECRUITING
Atlanta
Massachusetts
McLean Hospital
RECRUITING
Belmont
Tufts Medical Center - 800 Washington St - PPDS
RECRUITING
Boston
Boston Neuro Research Center
RECRUITING
North Dartmouth
Local Institution - 1250
COMPLETED
South Dartmouth
Elixia Health - Springfield - Elixia - PPDS
RECRUITING
Springfield
Michigan
Neurobehavioral Medicine Group (NBMG)
RECRUITING
Bloomfield Township
Missouri
Tekton Research, LLC - Saint Louis Psychiatry - PPDS
RECRUITING
St Louis
Mississippi
Precise Research Centers
RECRUITING
Flowood
North Carolina
Triad Clinical Trials - 515 College Rd
RECRUITING
Greensboro
AMC Research, LLC - Flourish - PPDS
RECRUITING
Matthews
Local Institution - 5005
WITHDRAWN
Morehead City
West Clinical Research
RECRUITING
Morehead City
Local Institution - 1252
WITHDRAWN
Shelby
New Jersey
Advanced Memory Research Institute - CenExel - PPDS
RECRUITING
Toms River
Local Institution - 1232
ACTIVE_NOT_RECRUITING
Toms River
New York
Mid Hudson Medical Research PLLC
RECRUITING
New Windsor
Local Institution - 1231
WITHDRAWN
Syracuse
SUNY Upstate Medical University
RECRUITING
Syracuse
Five Towns Neurology, PC
RECRUITING
Woodmere
Ohio
Local Institution - 1265
NOT_YET_RECRUITING
Cleveland
Ohio State University
RECRUITING
Columbus
Local Institution - 1258
NOT_YET_RECRUITING
Dayton
Insight Clinical Trials LLC - Independence
RECRUITING
Independence
Oklahoma
The Rivus Wellness & Research Institute
RECRUITING
Oklahoma City
Rhode Island
Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
RECRUITING
Providence
South Carolina
Local Institution - 1267
NOT_YET_RECRUITING
Columbia
Tennessee
Vanderbilt Psychiatric Hospital
RECRUITING
Nashville
Texas
Senior Adults Specialty Research
RECRUITING
Austin
Local Institution - 1260
NOT_YET_RECRUITING
Dallas
Epic Medical Research LLC - DeSoto
RECRUITING
Desoto
Advanced Neuro Research Center - El Paso
RECRUITING
El Paso
Local Institution - 1262
NOT_YET_RECRUITING
Fort Worth
Local Institution - 1261
NOT_YET_RECRUITING
Houston
University Hills Clinical Research - 102 Decker Ct
RECRUITING
Irving
Local Institution - 1238
COMPLETED
Plano
Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
RECRUITING
San Antonio
Local Institution - 1134
COMPLETED
Stafford
Virginia
Local Institution - 1266
NOT_YET_RECRUITING
Salem
Conquest Research, LLC - Virginia - Vienna
RECRUITING
Vienna
Washington
Northwest Clinical Research Center
RECRUITING
Bellevue
Local Institution - 1254
WITHDRAWN
Kirkland
Other Locations
Argentina
Fundación Para La Lucha Contra Las Enfermedades Neurológicas de La Infancia - FLENI
RECRUITING
Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Organización Médica de Investigación
RECRUITING
Buenos Aires
Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.
RECRUITING
Ciudad Autónoma De Buenos Aires
CINME S.A. - Centro de Investigaciones Metabólicas - Viamonte 2213/2215
RECRUITING
Ciudad Autónoma De Buenos Aires
Fundación para el Estudio y Tratamiento de Enfermedades mentales- FETEM
RECRUITING
Ciudad Autónoma De Buenos Aires
Centro Especializado en Neurociencias - CEN
RECRUITING
Córdoba
Instituto Privado Kremer
RECRUITING
Córdoba
Instituto Médico de la Fundación Estudios Clínicos
RECRUITING
Rosario
Belgium
Local Institution - 2804
COMPLETED
Alken
Local Institution - 2807
WITHDRAWN
Bruges
Local Institution - 2806
COMPLETED
Jette
Local Institution - 2805
COMPLETED
Kortrijk
Local Institution - 2803
COMPLETED
Roeselare
Brazil
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
RECRUITING
Brasília
Ruschel Medicina
RECRUITING
Rio De Janeiro
BR Trials - Pesquisa Clínica
RECRUITING
São Paulo
Clinilive
RECRUITING
São Paulo
CPQuali Pesquisa Clínica Sao Paulo
RECRUITING
São Paulo
Hospital Alemao Oswaldo Cruz (HAOC)
RECRUITING
São Paulo
Instituto de Psiquiatria HC FMUSP
RECRUITING
São Paulo
Bulgaria
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD-66 Peshtersko Shosse blvd
RECRUITING
Plovdiv
University Multiprofile Hospital For Active Treatment Kanev AD
RECRUITING
Rousse
Local Institution - 4506
COMPLETED
Sofia
Local Institution - 4510
WITHDRAWN
Sofia
Medical Center Medika 2005 - Branch Sofia
RECRUITING
Sofia
China
Beijing Anding Hospital Capital Medical University
RECRUITING
Beijing
Beijing Hospital
RECRUITING
Beijing
China-Japan Friendship Hospital
RECRUITING
Beijing
Xiangya Hospital Central South University
RECRUITING
Changsha
West China Hospital Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Local Institution - 7008
WITHDRAWN
Guangzhou
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qiantang Campus
RECRUITING
Hangzhou
Zhejiang Hospital - Lingyin Campus
RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
Nanjing Brain Hospital
RECRUITING
Nanjing
The Second Affiliated Hospital of Nanjing Medical University - Main Campus
RECRUITING
Nanjing
The Affiliated Kangning Hospital of Ningbo University - Zhuangshi Campus
RECRUITING
Ningbo
Local Institution - 7026
NOT_YET_RECRUITING
Shanghai
Shanghai Mental Health Center - PPDS
RECRUITING
Shanghai
Tongji Hospital of Tongji University
RECRUITING
Shanghai
Shenzhen Kangning Hospital
RECRUITING
Shenzhen
Tianjin Anding Hospital(Tianjin mental Health Center)
RECRUITING
Tianjin
The Mental Health Center of Xi'an
RECRUITING
Xi'an
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Croatia
Local Institution - 4101
COMPLETED
Zagreb
Local Institution - 4102
COMPLETED
Zagreb
Local Institution - 4104
COMPLETED
Zagreb
Local Institution - 4105
COMPLETED
Zagreb
Local Institution - 4106
WITHDRAWN
Zagreb
France
Local Institution - 2510
COMPLETED
Nice
CHU de Toulouse- Gerontopole
RECRUITING
Toulouse
Local Institution - 2512
WITHDRAWN
Toulouse
CHRU de Tours - Hôpital Bretonneau
RECRUITING
Tours
Germany
Local Institution - 2406
WITHDRAWN
Berlin
Local Institution - 2407
WITHDRAWN
Böblingen
Local Institution - 2404
COMPLETED
Erbach Im Odenwald
Local Institution - 2405
COMPLETED
Frankfurt Am Main
Local Institution - 2402
COMPLETED
Homburg
Greece
Local Institution - 4803
COMPLETED
Athens
Local Institution - 4802
COMPLETED
Chaidari, Athens
PAGNI-University General Hospital of Heraklion
RECRUITING
Heraklion
Local Institution - 4810
COMPLETED
Kalyftaki-n. Kifissia
Local Institution - 4811
COMPLETED
Thessaloniki
Hungary
Eszak-budai Szent Janos Centrumkorhaz
RECRUITING
Budapest
Semmelweis Egyetem Pszichiátriai és Pszichoterápiás Klinika
RECRUITING
Budapest
Clinexpert Gyöngyös Kft.
RECRUITING
Gyöngyös
Psychotech Kft.
RECRUITING
Pécs
Local Institution - 4610
WITHDRAWN
Szeged
India
Jawaharlal Nehru Medical College, Ajmer
RECRUITING
Ajmer
Local Institution - 1-13SNAZL0
NOT_YET_RECRUITING
Aurangabad
Postgraduate Institute of Medical Education & Research (PGIMER)
RECRUITING
Chandigarh
Asha Hospital - Hyderabad
RECRUITING
Hyderabad
Institute of Neurosciences Kolkata
RECRUITING
Kolkata
Central Institute of Behavioural Sciences
RECRUITING
Nagpur
Deva Institute of Healthcare & Research (DIHR) Pvt Ltd (Deva Institute of Healthcare)
RECRUITING
Varanasi
Israel
Local Institution - 3103
COMPLETED
Ashkelon
Local Institution - 3101
COMPLETED
Jerusalem
Local Institution - 3102
COMPLETED
Petah Tikva
Local Institution - 3104
COMPLETED
Ramat Gan
Italy
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
RECRUITING
Brescia
Local Institution - 2323
COMPLETED
Milan
Local Institution - 2307
COMPLETED
Ponderano (biella)
Local Institution - 2309
COMPLETED
Roma
Local Institution - 2320
COMPLETED
Rome
Local Institution - 2321
WITHDRAWN
Rome
Local Institution - 2322
COMPLETED
Rome
Local Institution - 2325
WITHDRAWN
Salerno
Japan
Local Institution - 7515
WITHDRAWN
Fukuoka
Local Institution - 7518
COMPLETED
Hachiōji
Hatano Kousei Hospital
RECRUITING
Hadano
Hyogo Prefectural Harima-Himeji General Medical Center
RECRUITING
Himeji-shi
Funairi nou clinic
RECRUITING
Hiroshima
Local Institution - 7503
COMPLETED
Iizuka
Local Institution - 7510
WITHDRAWN
Kanzaki-gun Yoshinogari-cho
Koukan Clinic
RECRUITING
Kawasaki-shi
Southern TOHOKU Medical Clinic
RECRUITING
Kōriyama
Yuge Neuropsychiatric Hospital
RECRUITING
Kumamoto
National Hospital Organization Utano National Hospital
RECRUITING
Kyoto
Asakayama General Hospital
RECRUITING
Sakai
Local Institution - 7522
COMPLETED
Sapporo
Kurumi Clinic
RECRUITING
Setagaya-ku
Sangenjaya Nakamura Mental Clinic
RECRUITING
Setagaya-ku
Tokyo Metropolitan Matsuzawa Hospital
RECRUITING
Setagaya-ku
Local Institution - 7514
COMPLETED
Takamatsu
Shin-Abuyama Hospital
RECRUITING
Takatsuki
Tsutsujimental Hospital
RECRUITING
Tatebayashi
Memory Clinic Toride
RECRUITING
Toride-shi
Local Institution - 7506
COMPLETED
Tsu
Local Institution - 7504
COMPLETED
Wako-shi
Local Institution - 7520
COMPLETED
Yokohama
Yokohama City Minato Red Cross Hospital
RECRUITING
Yokohama
Yokohama City University Hospital
RECRUITING
Yokohama
Local Institution - 7512
COMPLETED
Yoshinogawa
Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
RECRUITING
Gdansk
Local Institution - 4207
WITHDRAWN
Iława
Osrodek Badan Klinicznych BD Research Sp. z o.o. - Andersa 3
RECRUITING
Iława
Local Institution - 4213
WITHDRAWN
Kielce
Local Institution - 7527
WITHDRAWN
Lodz
Pro Salus Sp. z o.o.sp. k
RECRUITING
Lodz
Local Institution - 4206
COMPLETED
Lublin
Centrum Medyczne HCP Szpital im. Jana Pawla II
RECRUITING
Poznan
RCMed Oddzial Sochaczew
RECRUITING
Sochaczew
Local Institution - 4211
COMPLETED
Wroclaw
Portugal
Local Institution - 2701
COMPLETED
Guimarães
Local Institution - 2704
COMPLETED
Lisbon
Local Institution - 2706
WITHDRAWN
Lisbon
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
RECRUITING
Lisbon
Local Institution - 2703
COMPLETED
Matosinhos Municipality
Local Institution - 2702
COMPLETED
Torres Vedras
Puerto Rico
Local Institution - 1301
COMPLETED
Bayamón
Local Institution - 1303
COMPLETED
Bayamón
Instituto De Neurologia Dra. Ivonne Fraga,Psc
RECRUITING
San Juan
Local Institution - 1304
ACTIVE_NOT_RECRUITING
San Juan
Local Institution - 1305
WITHDRAWN
San Juan
Republic of Korea
Local Institution - 7214
COMPLETED
Ansan-si
Hallym University Chuncheon Sacred Heart Hospital
RECRUITING
Gangwon-do
Ewha Womans University Mokdong Hospital
RECRUITING
Seoul
Ewha Womans University Seoul Hospital
RECRUITING
Seoul
Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Local Institution - 1-14KMN4SY
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
SMG - SNU Boramae Medical Center
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
The Catholic University of Korea, Yeouido St. Mary's Hospital
RECRUITING
Yeongdeungpo-gu
Yongin Severance Hospital, Yonsei University Health System
RECRUITING
Yongin-si
Romania
Local Institution - 4907
NOT_YET_RECRUITING
Bucharest
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
RECRUITING
Bucharest
Cai Ferate Clinical Hospital Constanta
RECRUITING
Constanța
Institutul Privat de Cercetări Melchisedec pentru Boli Autoimune, Ereditare și Rare -I.P.C.M
RECRUITING
Craiova
Local Institution - 4905
WITHDRAWN
Iași
CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie
RECRUITING
Oradea
S.C. Carpe Diem SRL
RECRUITING
Sibiu
Serbia
Clinical Hospital Center Dragisa Misovic Dedinje
RECRUITING
Belgrade
Military Medical Academy
RECRUITING
Belgrade
Military Medical Academy
RECRUITING
Belgrade
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
RECRUITING
Belgrade
Local Institution - 4312
ACTIVE_NOT_RECRUITING
Gornja Toponica
Local Institution - 4305
COMPLETED
Kovin
University Clinical Center Kragujevac
RECRUITING
Kragujevac
Clinical Centre of Vojvodina
RECRUITING
Novi Sad
Slovakia
MUDr. Beata Dupejova - Neurologicka Ambulancia s.r.o
RECRUITING
Banská Bystrica
KONZILIUM s.r.o
RECRUITING
Dubnica Nad Váhom
Local Institution - 4406
COMPLETED
Košice
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
RECRUITING
Košice
Local Institution - 4407
COMPLETED
Pezinok
Local Institution - 4403
COMPLETED
Vranov Nad Topľou
Spain
Local Institution - 2212
COMPLETED
Lleida
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda
RECRUITING
Majadahonda
Hospital Quironsalud Malaga
RECRUITING
Málaga
Hospital Universitario De Salamanca
RECRUITING
Salamanca
Hospital Victoria Eugenia
RECRUITING
Seville
Hospital Universitario Rio Hortega
RECRUITING
Valladolid
Hospital Viamed Montecanal
RECRUITING
Zaragoza
Turkey
Hacettepe University Medical Faculty
RECRUITING
Ankara
Local Institution - 4702
COMPLETED
Atakum
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
RECRUITING
Eskişehir
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
RECRUITING
Istanbul
Local Institution - 4703
COMPLETED
Izmir
Local Institution - 4705
COMPLETED
Izmir
Ukraine
Municipal NonProfit Enterprise Khmelnytskyi Regional Psychiatric Care Facility of the Khmelnytskyi Regional Council
RECRUITING
Khmelnytskyi
Iqmed Llc
RECRUITING
Lviv
Municipal non-profit enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital
RECRUITING
Lviv
MNE Cherkasy Regional Psychiatric Hospital of Cherkasy RC
RECRUITING
Smila
MNE Ternopil Regional Clinical Psychoneurological Hospital of TRC
RECRUITING
Ternopil
Neyromed LLC - Uzhhorod
RECRUITING
Uzhhorod
Local Institution - 8001
NOT_YET_RECRUITING
Vinnytsia
MI Vinnytsia Regional Psychoneurological Hospital n.a. acad. O.I. Yushchenko
RECRUITING
Vinnytsia
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2024-09-26
Estimated Completion Date: 2026-12-22
Participants
Target number of participants: 406
Treatments
Experimental: KarXT
Experimental: Placebo
Related Therapeutic Areas
Sponsors
Leads: Karuna Therapeutics, Inc., a Bristol Myers Squibb company