A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4)
- Registration Number
- NCT06585787
- Lead Sponsor
- Karuna Therapeutics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 406
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KarXT KarXT - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score Up to Week 14
- Secondary Outcome Measures
Name Time Method Change from baseline in Clinical Global Impressions-Severity (CGI-S) scale Up to Week 14 Change from baseline in Neuropsychiatric Inventory-Clinician (NPI-C) Core score: Hallucination Domain Up to Week 14 Change from baseline in NPI-C Core score: Delusion Domain Up to Week 14 Change from baseline in NPI-C Core score: Agitation Domain Up to Week 14 Change from baseline in NPI-C Core score: Aggression Domain Up to Week 14 Change from baseline in NPI-C Agitation score Up to Week 14 Change from baseline in NPI-C Core score: Caregiver Distress Scale Up to Week 14 Number of participants with a ≥ 40% improvement from Baseline in NPI-C: H+D score Up to Week 14 Change from baseline in Cohen- Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) total score Up to Week 14 Change from baseline in Cohen- Mansfield Agitation Inventory (CMAI) total score Up to Week 14 Number of participants with Adverse Events (AEs) Up to Week 14 Number of participants with Treatment-Emergent Adverse Events (TEAEs) Up to Week 14 Number of participants with Serious Adverse Events (SAEs) Up to Week 14 Number of participants with TEAEs leading to study withdrawal Up to Week 14 Number of participants with procholinergic symptoms Up to Week 14 Number of participants with anticholinergic symptoms Up to Week 14 Number of participants with AEs of Special Interest (AESIs) Up to Week 14 Barnes Akathisia Rating Scale (BARS) Score Up to Week 14 Abnormal Involuntary Movement Scale (AIMS) Score Up to Week 14 Body Weight Up to Week 14 Body Mass Index (BMI) Up to Week 14 Number of participants with vital sign abnormalities Up to Week 14 Number of participants with clinical laboratory abnormalities Up to Week 14 Number of participants with 12-lead electrocardiogram (ECG) abnormalities Up to Week 14 Number of participants with suicidal ideation as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Up to Week 14 Cognition as assessed by the Mini-Mental State Examination (MMSE) Up to Week 14 Cognition as assessed by the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) Up to Week 14
Trial Locations
- Locations (214)
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
JY Research Institute Inc
🇺🇸Cutler Bay, Florida, United States
Chandler Clinical Trials, LLC
🇺🇸Chandler, Arizona, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Long Beach Research Institute, LLC
🇺🇸Long Beach, California, United States
Local Institution - 1226
🇺🇸Los Angeles, California, United States
Local Institution - 1219
🇺🇸Los Angeles, California, United States
ATP Clinical Research-302 W La Veta Ave
🇺🇸Orange, California, United States
Arrow Clinical Trials
🇺🇸Daytona Beach, Florida, United States
NRC Research Institute - Orange - PPDS
🇺🇸Orange, California, United States
SC3 Research - Pasadena - 960 E. Green St
🇺🇸Pasadena, California, United States
Prospective Research Innovations 8577 Haven Ave
🇺🇸Rancho Cucamonga, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Genesis Trust Research Group
🇺🇸Atlantis, Florida, United States
Envision Trials LLC
🇺🇸Bonita Springs, Florida, United States
Quantum Laboratories, Inc - West Palm Beach Office
🇺🇸Deerfield Beach, Florida, United States
Integrity Clinical Research, LLC - 8000 NW 21st St
🇺🇸Doral, Florida, United States
New Life Medical Research Center -3750 W 16th Ave
🇺🇸Hialeah, Florida, United States
Research in Miami, Inc
🇺🇸Hialeah, Florida, United States
Nexus Clinical Research Center- NRC
🇺🇸Homestead, Florida, United States
K2 Medical Research - Lady Lake
🇺🇸Lady Lake, Florida, United States
New Med Research
🇺🇸Miami Gardens, Florida, United States
Panax Clinical Research
🇺🇸Miami Lakes, Florida, United States
Angels Clinical Research Institute - Miami Lakes
🇺🇸Miami Lakes, Florida, United States
Homestead Associates in Research Inc
🇺🇸Miami, Florida, United States
Clinical Hospital Center Dragisa Misovic Dedinje
🇷🇸Belgrade, Serbia
Premier Clinical Research Institute - Miami - ClinEdge - PPDS
🇺🇸Miami, Florida, United States
Dade Research Center
🇺🇸Miami, Florida, United States
Wellness Research Center Inc - Miami
🇺🇸Miami, Florida, United States
A & D Doctor Center
🇺🇸Miami, Florida, United States
Floridian Neuroscience Institute-1901 SW 1 St
🇺🇸Miami, Florida, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
MedOne Clinical Research LLC
🇺🇸Miami, Florida, United States
My Community Research Center, Inc - 7480 Bird Rd
🇺🇸Miami, Florida, United States
Future Care Solution LLC
🇺🇸Miami, Florida, United States
Reliant Medical Research
🇺🇸Miami, Florida, United States
Novel Clinical Research Center, LLC.
🇺🇸Miami, Florida, United States
US Associates in Research Inc
🇺🇸Miami, Florida, United States
Serenity Research Center
🇺🇸Miami, Florida, United States
IMIC LLC- 9380 SW 150th Str
🇺🇸Miami, Florida, United States
New Gen Health
🇺🇸Miami, Florida, United States
Floridian Research Institute-1021 Ives Dairy Rd
🇺🇸Miami, Florida, United States
High Quality Research
🇺🇸Miami, Florida, United States
Sensible HealthCare, LLC - ClinEdge - PPDS
🇺🇸Ocoee, Florida, United States
Combined Research Orlando Phase I-IV
🇺🇸Orlando, Florida, United States
Neurology Associates of Ormond Beach
🇺🇸Ormond Beach, Florida, United States
Progressive Medical Research (Duplicate)
🇺🇸Port Orange, Florida, United States
Cordova Research Institute- Sweetwater
🇺🇸Sweetwater, Florida, United States
Angels Clinical Research Institute Tampa
🇺🇸Tampa, Florida, United States
Interventional Psychiatry of Tampa Bay
🇺🇸Tampa, 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
Local Institution - 1239
🇺🇸Springfield, Massachusetts, United States
Precise Research Centers - ClinEdge - PPDS
🇺🇸Flowood, Mississippi, United States
Advanced Memory Research Institute - CenExel - PPDS
🇺🇸Toms River, New Jersey, United States
Bio Behavioral Health
🇺🇸Toms River, New Jersey, United States
Local Institution - 1231
🇺🇸Syracuse, New York, United States
Five Towns Neurology, PC
🇺🇸Woodmere, New York, United States
Triad Clinical Trials
🇺🇸Greensboro, North Carolina, United States
AMC Research, LLC - Flourish - PPDS
🇺🇸Matthews, North Carolina, United States
Local Institution - 5005
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
West Clinical Research
🇺🇸Morehead City, North Carolina, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Alzheimer's Disease and Memory Disorders Center at Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Local Institution - 1211
🇺🇸Nashville, Tennessee, United States
Epic Medical Research LLC - DeSoto
🇺🇸DeSoto, Texas, United States
Advanced Neuro Research Center - El Paso
🇺🇸El Paso, Texas, United States
Local Institution - 1238
🇺🇸Plano, Texas, United States
Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases
🇺🇸San Antonio, Texas, United States
R & H Clinical Research-3727 Greenbriar Dr
🇺🇸Stafford, Texas, United States
Local Institution - 5004
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 5001
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 5006
🇦🇷Buenos Aires, Argentina
Local Institution - 5002
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Local Institution - 5003
🇦🇷Cordoba, Argentina
Local Institution - 5007
🇦🇷San Rafael, Argentina
Local Institution - 2806
🇧🇪Jette, Brussels, Belgium
AZ Delta- Campus Rumbeke
🇧🇪Roeselare, West-Vlaanderen, Belgium
ANIMA Research Center - PPDS
🇧🇪Alken, Belgium
Local Institution - 2807
🇧🇪Brugge, Belgium
Local Institution - 2805
🇧🇪Kortrijk, Belgium
Local Institution - 6201
🇧🇷Brasília, Distrito Federal, Brazil
Local Institution - 6202
🇧🇷São Paulo, SAO Paulo, Brazil
Local Institution - 6206
🇧🇷São Paulo, SAO Paulo, Brazil
Local Institution - 6205
🇧🇷São Paulo, SAO Paulo, Brazil
Local Institution - 6203
🇧🇷São Paulo, SAO Paulo, Brazil
Local Institution - 6204
🇧🇷Rio de Janeiro, Brazil
Local Institution - 4506
🇧🇬Sofia, Sofia-Grad, Bulgaria
Local Institution - 4508
🇧🇬Plovdiv, Bulgaria
Local Institution - 4507
🇧🇬Ruse, Bulgaria
Local Institution - 4509
🇧🇬Sofia, Bulgaria
Local Institution - 4105
🇭🇷Zagreb, GRAD Zagreb, Croatia
Polyclinic Neuron
🇭🇷Zagreb, Grad Zagreb, Croatia
Klinika za psihijatriju Vrapce
🇭🇷Zagreb, Grad Zagreb, Croatia
Psychiatric Clinic Sveti Ivan
🇭🇷Zagreb, Grad Zagreb, Croatia
Tsurumi Nishii Hospital
🇯🇵Yokohama, Kanagawa, Japan
Local Institution - 2510
🇫🇷Nice, Alpes-Maritimes, France
Local Institution - 2511
🇫🇷Tours, Indre-et-Loire, France
Local Institution - 2512
🇫🇷Toulouse, France
CHU de Toulouse- Gerontopole
🇫🇷Toulouse, France
Local Institution - 2407
🇩🇪Böblingen, Baden-Württemberg, Germany
NeuroCentrum Odenwald
🇩🇪Erbach, Hessen, Germany
Universitatsklinikum des Saarlandes
🇩🇪Homburg, Saarland, Germany
Local Institution - 2406
🇩🇪Berlin, Germany
Local Institution - 2405
🇩🇪Frankfurt am Main, Germany
Henry Dunant Hospital Center
🇬🇷Athina, Attiki, Greece
Local Institution - 4802
🇬🇷Chaidari, Athens, Attiki, Greece
Local Institution - 4810
🇬🇷Kalyftaki-N. Kifissia, Attiki, Greece
Local Institution - 4801
🇬🇷Heraklion, Irakleio, Greece
Local Institution - 4811
🇬🇷Thessaloniki, Greece
Psychotech Kft.
🇭🇺Pécs, Baranya, Hungary
Local Institution - 4610
🇭🇺Szeged, Csongrád, Hungary
Local Institution - 4611
🇭🇺Gyöngyös, Heves, Hungary
Semmelweis Egyetem Pszichiátriai és Pszichoterápiás Klinika
🇭🇺Budapest, Hungary
Local Institution - 4612
🇭🇺Budapest, Hungary
Local Institution - 7403
🇮🇳Hyderabad, Andhra Pradesh, India
Local Institution - 7401
🇮🇳Nagpur, Maharashtra, India
Local Institution - 7404
🇮🇳Kolkata, West Bengal, India
Local Institution - 7402
🇮🇳Varanasi, India
The Barzilai University Medical Center
🇮🇱Ashkelon, Tel-Aviv, Israel
Hadassah Medical Center- Ein Kerem - PPDS
🇮🇱Jerusalem, Yerushalayim, Israel
Rabin Medical Center - PPDS
🇮🇱Petah Tikva, Israel
The Chaim Sheba Medical Center - PPDS
🇮🇱Ramat -Gan, Israel
Local Institution - 2322
🇮🇹Roma, Lazio, Italy
IRCCS San Raffaele- Via di Val Cannuta 250
🇮🇹Roma, Lazio, Italy
Local Institution - 2324
🇮🇹Brescia, Lombardia, Italy
Local Institution - 2323
🇮🇹Milano, Lombardia, Italy
Local Institution - 2307
🇮🇹Ponderano (Biella), Piemonte, Italy
Local Institution - 2321
🇮🇹Rome, Roma, Italy
Local Institution - 2309
🇮🇹Roma, Italy
Iizuka Memorial Hospital
🇯🇵Iizuka, Fukuoka, Japan
Local Institution - 7525
🇯🇵Koriyama, Fukushima, Japan
Teine Keijinkai Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Prefectural Harima-Himeji General Medical Center
🇯🇵Himeji-Shi, Hyogo, Japan
Memory Clinic Toride
🇯🇵Toride-shi, Ibaraki, Japan
Kagawa Prefectural Central Hospital
🇯🇵Takamatsu-Shi, Kagawa, Japan
Hatano Kousei Hospital
🇯🇵Hadano, Kanagawa, Japan
Koukan Clinic
🇯🇵Kawasaki-Shi, Kanagawa, Japan
Yokohama City Minato Red Cross Hospital
🇯🇵Yokohama-Shi, Kanagawa, Japan
Yokohama City University Hospital
🇯🇵Yokohama, Kanagawa, Japan
National Hospital Organization Utano National Hospital
🇯🇵Kyoto-Shi, Kyoto, Japan
National Hospital Organization Miechuo Medical Center
🇯🇵Tsu-Shi, MIE, Japan
Asakayama General Hospital
🇯🇵Sakai, Osaka, Japan
Shin-Abuyama Hospital
🇯🇵Takatsuki, Osaka, Japan
Local Institution - 7510
🇯🇵Kanzaki-Gun Yoshinogari-Cho, Saga, Japan
Local Institution - 7504
🇯🇵Wako-Shi, Saitama, Japan
NHO Tokushima Medical Center West
🇯🇵Yoshinogawa, Tokushima, Japan
Tokyo Angel Hospital
🇯🇵Hachioji, Tokyo, Japan
Sangenjaya Nakamura Mental Clinic
🇯🇵Setagaya-Ku, Tokyo, Japan
Kurumi Clinic
🇯🇵Setagaya-Ku, Tokyo, Japan
Local Institution - 7515
🇯🇵Fukuoka, Japan
Funairi nou clinic
🇯🇵Hiroshima, Japan
Yuge Neuropsychiatric Hospital
🇯🇵Kumamoto, Japan
Tsutsujimental Hospital
🇯🇵Tatebayashi, Japan
Local Institution - 7214
🇰🇷Ansan-si, Gyeonggido, Korea, Republic of
Local Institution - 7217
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 7213
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 7215
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
Local Institution - 7212
🇰🇷Yeongdeungpo-Gu, Seoul Teugbyeolsi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Local Institution - 7216
🇰🇷Yongin-si, Korea, Republic of
4 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ
🇵🇱Wroclaw, Dolnoslaskie, Poland
Uniwersyteckie Centrum Kliniczne w Gdansku - Smoluchowskiego 17
🇵🇱Gdansk, Pomorskie, Poland
Local Institution - 4213
🇵🇱Kielce, Poland
Pro Salus Sp. z o.o.sp. k
🇵🇱Lodz, Poland
NZOZ NEUROMED M. I M. Nastaj Spolka Partnerska -Lublin
🇵🇱Lublin, Poland
Centrum Medyczne HCP Szpital im. Jana Pawla II
🇵🇱Poznan, Poland
ULS do Alto Ave, EPE - Hospital da Senhora da Oliveira Guimarães
🇵🇹Guimarães, Braga, Portugal
Local Institution - 2704
🇵🇹Lisbon, Lisboa, Portugal
Campus Neurológico Sénior
🇵🇹Torres Vedras, Lisboa, Portugal
ULS de Matosinhos, EPE - Hospital Pedro Hispano
🇵🇹Matosinhos, Porto, Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria - PPDS
🇵🇹Lisboa, Portugal
Local Institution - 2706
🇵🇹Lisboa, Portugal
Santa Cruz Behavioral PSC
🇵🇷Bayamon, Puerto Rico
CDT Grupo Medico San Pablo Inc.
🇵🇷Bayamon, Puerto Rico
Instituto De Neurologia Dra. Ivonne Fraga,Psc
🇵🇷San Juan, Puerto Rico
Barbara Diaz Hernandez MD Research Inc
🇵🇷San Juan, Puerto Rico
Local Institution - 1305
🇵🇷San Juan, Puerto Rico
CMI Dr. Buhas Ramocea Elena Daniela - Cabinet Medical de Psihiarie
🇷🇴Oradea, Bihor, Romania
Local Institution - 4906
🇷🇴Bucuresti, Romania
Local Institution - 4902
🇷🇴Constanta, Romania
Local Institution - 4903
🇷🇴Craiova, Romania
Local Institution - 4905
🇷🇴Iasi, Romania
S.C. Carpe Diem SRL
🇷🇴Sibiu, Romania
University Clinical Center of Serbia - Dr Subotica 6 - PPDS
🇷🇸Beograd, Belgrade, Serbia
Local Institution - 4308
🇷🇸Belgrade, Serbia
Local Institution - 4314
🇷🇸Belgrade, Serbia
Special Hospital for Psychiatric Diseases Gornja Toponica
🇷🇸Gornja Toponica, Serbia
Special Hospital for Psychiatric Diseases Kovin
🇷🇸Kovin, Serbia
University Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Local Institution - 4309
🇷🇸Novi Sad, Serbia
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
🇸🇰Kosice, Košický Kraj, Slovakia
MUDr. Beata Dupejova - Neurologicka Ambulancia s.r.o
🇸🇰Banska Bystrica, Slovakia
KONZILIUM s.r.o
🇸🇰Dubnica nad Váhom, Slovakia
EPAMED s.r.o
🇸🇰Košice, Slovakia
Psychiatrická nemocnica Philippa Pinela Pezinok
🇸🇰Pezinok, Slovakia
Crystal Comfort, s.r.o.
🇸🇰Vranov nad Topľou, Slovakia
Hospital Universitario Puerta de Hierro - Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Universitari Santa Maria
🇪🇸Lleida, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario De Salamanca
🇪🇸Salamanca, Spain
Hospital Victoria Eugenia
🇪🇸Sevilla, Spain
Hospital Universitario Rio Hortega
🇪🇸Valladolid, Spain
Local Institution - 4702
🇹🇷Atakum, Samsun, Turkey
Local Institution - 4706
🇹🇷Ankara, Turkey
Local Institution - 4701
🇹🇷Eskisehir, Turkey
Local Institution - 4704
🇹🇷Istanbul, Turkey
Local Institution - 4705
🇹🇷Izmir, Turkey
Local Institution - 4703
🇹🇷Izmir, Turkey