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 (281) 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
Chandler Clinical Trials, LLC
RECRUITING
Chandler
Gilbert Neurology Partners - PLLC - Avacare
RECRUITING
Gilbert
Banner Alzheimer's Institute
RECRUITING
Phoenix
Scottsdale Clinical Trials
RECRUITING
Scottsdale
California
Advanced Research Center, Inc.
RECRUITING
Anaheim
Inland Psychiatric Medical Group (IPMG)-Chino
RECRUITING
Chino
Long Beach Research Institute, LLC
RECRUITING
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WITHDRAWN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
NRC Research Institute - Orange - PPDS
RECRUITING
Orange
SC3 Research - Pasadena - 960 E. Green St
RECRUITING
Pasadena
Prospective Research Innovations 8577 Haven Ave
RECRUITING
Rancho Cucamonga
Connecticut
University of Connecticut Health Center
RECRUITING
Farmington
Florida
Genesis Trust Research Group
RECRUITING
Atlantis
Envision Trials LLC
RECRUITING
Bonita Springs
JY Research Institute Inc
RECRUITING
Cutler Bay
Arrow Clinical Trials
RECRUITING
Daytona Beach
Quantum Laboratories, Inc - West Palm Beach Office
RECRUITING
Deerfield Beach
Integrity Clinical Research LLC - 21st Street
RECRUITING
Doral
New Life Medical Research Center -3750 W 16th Ave
RECRUITING
Hialeah
Research in Miami, Inc
RECRUITING
Hialeah
Nexus Clinical Research Center- NRC
RECRUITING
Homestead
K2 Medical Research - Lady Lake
RECRUITING
Lady Lake
A & D Doctor Center
RECRUITING
Miami
Dade Research Center - Miami FL - 7600 SW 87th Ave
RECRUITING
Miami
Floridian Neuroscience Institute-1901 SW 1 St
RECRUITING
Miami
Floridian Research Institute- Ives Dairy Road
RECRUITING
Miami
Future Care Solution LLC
RECRUITING
Miami
High Quality Research
RECRUITING
Miami
Homestead Associates in Research Inc
RECRUITING
Miami
IMIC LLC- 9380 SW 150th Str
RECRUITING
Miami
Local Institution - 1158
COMPLETED
Miami
MedOne Clinical Research LLC
RECRUITING
Miami
Miami Jewish Health Systems
RECRUITING
Miami
My Community Research Center, Inc - 7480 Bird Rd
RECRUITING
Miami
New Gen Health
RECRUITING
Miami
Novel Clinical Research Center, LLC.
RECRUITING
Miami
Premier Clinical Research Institute
RECRUITING
Miami
Reliant Medical Research
RECRUITING
Miami
Serenity Research Center
RECRUITING
Miami
Wellness Research Center Inc - Miami
RECRUITING
Miami
New Med Research
RECRUITING
Miami Gardens
Angels Clinical Research Institute - Miami Lakes - Palm Springs - PPDS
RECRUITING
Miami Lakes
Panax Clinical Research
RECRUITING
Miami Lakes
Aqualane Clinical Research
RECRUITING
Naples
Sensible HealthCare, LLC
RECRUITING
Ocoee
Combined Research Orlando Phase I-IV LLC
RECRUITING
Orlando
Local Institution - 1257
NOT_YET_RECRUITING
Orlando
Nova Psychiatry
RECRUITING
Orlando
Neurology Associates of Ormond Beach
RECRUITING
Ormond Beach
Progressive Medical Research (Duplicate)
RECRUITING
Port Orange
Cordova Research Institute- Sweetwater
RECRUITING
Sweetwater
Angels Clinical Research Institute Tampa - Palm Springs - PPDS
RECRUITING
Tampa
Guardian Angel Research
RECRUITING
Tampa
Interventional Psychiatry of Tampa Bay
RECRUITING
Tampa
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
NOT_YET_RECRUITING
South Dartmouth
Elixia Health - Springfield - Elixia - PPDS
RECRUITING
Springfield
Michigan
Neurobehavioral Medicine Group (NBMG)
RECRUITING
Bloomfield Township
Missouri
Local Institution - 1255
NOT_YET_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
NOT_YET_RECRUITING
Shelby
New Jersey
Advanced Memory Research Institute - CenExel - PPDS
RECRUITING
Toms River
Bio Behavioral Health
RECRUITING
Toms River
New York
Local Institution - 1251
NOT_YET_RECRUITING
New Windsor
Local Institution - 1231
WITHDRAWN
Syracuse
Local Institution - 1240
NOT_YET_RECRUITING
Syracuse
Five Towns Neurology, PC
RECRUITING
Woodmere
Ohio
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
Tennessee
Vanderbilt Psychiatric Hospital
RECRUITING
Nashville
Texas
Epic Medical Research LLC - DeSoto - HyperCore - PPDS
RECRUITING
Desoto
Advanced Neuro Research Center - El Paso
RECRUITING
El Paso
AIM Trials
RECRUITING
Plano
Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
RECRUITING
San Antonio
Local Institution - 1134
COMPLETED
Stafford
Virginia
Conquest Research, LLC - Virginia - Vienna
RECRUITING
Vienna
Washington
Local Institution - 1253
NOT_YET_RECRUITING
Bellevue
Local Institution - 1254
NOT_YET_RECRUITING
Kirkland
Other Locations
Argentina
Hospital Italiano de Buenos Aires
RECRUITING
Buenos Aires
Local Institution - 5006
NOT_YET_RECRUITING
Buenos Aires
Local Institution - 5009
NOT_YET_RECRUITING
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
Local Institution - 5005
NOT_YET_RECRUITING
Ciudad Autónoma De Buenos Aires
Instituto Privado Kremer
RECRUITING
Córdoba
Local Institution - 5008
NOT_YET_RECRUITING
Rosario
Local Institution - 5007
NOT_YET_RECRUITING
San Rafael
Belgium
ANIMA Research Center - PPDS
RECRUITING
Alken
Local Institution - 2807
WITHDRAWN
Bruges
UZ Brussel - PPDS
RECRUITING
Jette
AZ Groeninge
RECRUITING
Kortrijk
AZ Delta- Campus Rumbeke
RECRUITING
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
Instituto de Psiquiatria HC FMUSP
RECRUITING
São Paulo
Local Institution - 6207
NOT_YET_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 - 4510
NOT_YET_RECRUITING
Sofia
Medical Center Intermedica OOD
RECRUITING
Sofia
Medical Center Medika 2005 - Branch Sofia
RECRUITING
Sofia
China
Local Institution - 7004
NOT_YET_RECRUITING
Beijing
Local Institution - 7005
NOT_YET_RECRUITING
Beijing
Local Institution - 7025
NOT_YET_RECRUITING
Beijing
Local Institution - 7027
NOT_YET_RECRUITING
Changsha
Local Institution - 7002
NOT_YET_RECRUITING
Chengdu
Local Institution - 7015
NOT_YET_RECRUITING
Chongqing
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Local Institution - 7008
WITHDRAWN
Guangzhou
Local Institution - 7020
NOT_YET_RECRUITING
Hangzhou
Local Institution - 7021
NOT_YET_RECRUITING
Hangzhou
Zhejiang Provincial People's Hospital
RECRUITING
Hangzhou
Local Institution - 7022
NOT_YET_RECRUITING
Kunming
Local Institution - 7024
NOT_YET_RECRUITING
Nanjing
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Local Institution - 7026
NOT_YET_RECRUITING
Shanghai
Shanghai Mental Health Center - PPDS
RECRUITING
Shanghai
Tongji Hospital of Tongji University
RECRUITING
Shanghai
Local Institution - 7003
NOT_YET_RECRUITING
Shenzhen
Local Institution - 7019
NOT_YET_RECRUITING
Tianjin
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Croatia
Klinika za psihijatriju Vrapce
RECRUITING
Zagreb
Local Institution - 4106
WITHDRAWN
Zagreb
Polyclinic Neuron
RECRUITING
Zagreb
Psychiatric Clinic Sveti Ivan
RECRUITING
Zagreb
University Hospital Center Zagreb
RECRUITING
Zagreb
France
Institut Claude Pompidou
RECRUITING
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
NeuroCentrum Odenwald
RECRUITING
Erbach Im Odenwald
Universitätsklinikum Frankfurt
RECRUITING
Frankfurt Am Main
Universitatsklinikum des Saarlandes
RECRUITING
Homburg
Greece
Henry Dunant Hospital Center
RECRUITING
Athens
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
RECRUITING
Chaidari, Athens
PAGNI-University General Hospital of Heraklion
RECRUITING
Heraklion
General Oncology Hospital of Kifissia ''Agioi Anargyroi''
RECRUITING
Kalyftaki-n. Kifissia
424 General Military Training Hospital-Outpatient Psychiatric Department
RECRUITING
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
Local Institution - 7406
NOT_YET_RECRUITING
Ajmer
Local Institution - 7405
NOT_YET_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
The Barzilai University Medical Center
RECRUITING
Ashkelon
Hadassah Medical Center- Ein Kerem - PPDS
RECRUITING
Jerusalem
Rabin Medical Center - PPDS
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center - PPDS
RECRUITING
Ramat Gan
Italy
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
RECRUITING
Brescia
Auxologico IRCCS - Auxologico San Luca
RECRUITING
Milan
ASL Biella - Ospedale degli Infermi
RECRUITING
Ponderano (biella)
Azienda Ospedaliero-Universitaria Sant'Andrea
RECRUITING
Roma
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155
RECRUITING
Rome
Local Institution - 2320
COMPLETED
Rome
Local Institution - 2321
WITHDRAWN
Rome
Local Institution - 2325
WITHDRAWN
Salerno
Japan
Local Institution - 7515
WITHDRAWN
Fukuoka
Tokyo Angel Hospital
RECRUITING
Hachiōji
Hatano Kousei Hospital
RECRUITING
Hadano
Hyogo Prefectural Harima-Himeji General Medical Center
RECRUITING
Himeji-shi
Funairi nou clinic
RECRUITING
Hiroshima
Iizuka Memorial Hospital
RECRUITING
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
Tokyo Metropolitan Geriatric Hospital
RECRUITING
Tabashi City
Kagawa Prefectural Central Hospital
RECRUITING
Takamatsu
Shin-Abuyama Hospital
RECRUITING
Takatsuki
Tsutsujimental Hospital
RECRUITING
Tatebayashi
Memory Clinic Toride
RECRUITING
Toride-shi
National Hospital Organization Miechuo Medical Center
RECRUITING
Tsu
Local Institution - 7504
COMPLETED
Wako-shi
Tsurumi Nishii Hospital
RECRUITING
Yokohama
Yokohama City Minato Red Cross Hospital
RECRUITING
Yokohama
Yokohama City University Hospital
RECRUITING
Yokohama
NHO Tokushima Medical Center West
RECRUITING
Yoshinogawa
Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
RECRUITING
Gdansk
Osrodek Badan Klinicznych BD Research Sp. z o.o. - Andersa 3
RECRUITING
Iława
Osrodek Badan Klinicznych BD Research Sp. z o.o. - Andersa 3
RECRUITING
Iława
Local Institution - 4213
WITHDRAWN
Kielce
Pro Salus Sp. z o.o.sp. k
RECRUITING
Lodz
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska -Lublin
RECRUITING
Lublin
Centrum Medyczne HCP Szpital im. Jana Pawla II
RECRUITING
Poznan
Local Institution - 4216
NOT_YET_RECRUITING
Sochaczew
Local Institution - 4211
COMPLETED
Wroclaw
Portugal
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
RECRUITING
Guimarães
Local Institution - 2706
WITHDRAWN
Lisbon
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
RECRUITING
Lisbon
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
RECRUITING
Lisbon
ULS de Matosinhos, EPE - Hospital Pedro Hispano
RECRUITING
Matosinhos Municipality
Campus Neurológico Sénior
RECRUITING
Torres Vedras
Puerto Rico
CDT Grupo Medico San Pablo Inc.
RECRUITING
Bayamón
Santa Cruz Behavioral PSC
RECRUITING
Bayamón
Barbara Diaz Hernandez MD Research Inc
RECRUITING
San Juan
Instituto De Neurologia Dra. Ivonne Fraga,Psc
RECRUITING
San Juan
Local Institution - 1305
WITHDRAWN
San Juan
Republic of Korea
Korea University Ansan Hospital
RECRUITING
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
Hanyang University Seoul Hospital
RECRUITING
Seoul
Local Institution - 7203
NOT_YET_RECRUITING
Seoul
Local Institution - 7219
NOT_YET_RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
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
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
Special Hospital for Psychiatric Diseases Gornja Toponica
RECRUITING
Gornja Toponica
Special Hospital for Psychiatric Diseases Kovin
RECRUITING
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
EPAMED s.r.o
RECRUITING
Košice
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
RECRUITING
Košice
Psychiatrická nemocnica Philippa Pinela Pezinok
RECRUITING
Pezinok
Crystal Comfort, s.r.o.
RECRUITING
Vranov Nad Topľou
Spain
Hospital Universitari Santa Maria
RECRUITING
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
Local Institution - 2206
NOT_YET_RECRUITING
Zaragoza
Turkey
Hacettepe University Medical Faculty
RECRUITING
Ankara
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
RECRUITING
Atakum
Eskisehir Osmangazi Universitesi Tip Fakultesi Hastanesi
RECRUITING
Eskişehir
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
RECRUITING
Istanbul
Dokuz Eylul Universitesi Arastirma ve Uygulama Hastanesi
RECRUITING
Izmir
IEU Medical Point Izmir Hastanesi
RECRUITING
Izmir
Ukraine
Local Institution - 8003
NOT_YET_RECRUITING
Khmelnytskyi
Local Institution - 8006
NOT_YET_RECRUITING
Lviv
Local Institution - 8007
NOT_YET_RECRUITING
Lviv
Local Institution - 8004
NOT_YET_RECRUITING
Smila
Local Institution - 8008
NOT_YET_RECRUITING
Ternopil
Local Institution - 8005
NOT_YET_RECRUITING
Uzhhorod
Local Institution - 8001
NOT_YET_RECRUITING
Vinnytsia
Local Institution - 8002
NOT_YET_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: 2026-10-19
Participants
Target number of participants: 406
Treatments
Experimental: KarXT
Experimental: Placebo
Related Therapeutic Areas
Sponsors
Leads: Karuna Therapeutics, Inc., a Bristol Myers Squibb company