A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
Start Date
8/23/2022
Completion Date
10/5/2026
Summary
This is a Phase 3, 38-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with psychosis associated with Alzheimer's Disease. The primary objective of the study is to evaluate relapse prevention in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo. The secondary objectives of the study are to evaluate the time from randomization to discontinuation for any reason or relapse and safety and tolerability in subjects with psychosis associated with Alzheimer's Disease treated with KarXT compared to placebo.
Eligibility Criteria
Age Range: 55 years to 90 years
Interventions
KarXT
Placebo
Conditions
Locations
Local Institution - 1029
Homewood, Alabama 35209-6809
United States
Local Institution - 1044
Phoenix, Arizona 85012-2836
United States
Local Institution - 1033
Encino, California 91436-2201
United States
Local Institution - 1031
Irvine, California 92612-1246
United States
ATP Clinical Research-302 W La Veta Ave
Orange, California 92866
United States
Local Institution - 1043
Pasadena, California 91106
United States
Local Institution - 1047
San Marcos, California 92069-3595
United States
Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS
Walnut Creek, California 94596
United States
Local Institution - 1014
Colorado Springs, Colorado 80907-5302
United States
Local Institution - 1013
Stamford, Connecticut 06905-1206
United States
Local Institution - 1011
Boca Raton, Florida 33487-2768
United States
Local Institution - 1020
Bonita Springs, Florida 34134
United States
Local Institution - 1015
Bradenton, Florida 34209-4687
United States
K2 Medical Research - Winter Garden
Clermont, Florida 34711-5933
United States
Arrow Clinical Trials
Daytona Beach, Florida 32117-5532
United States
Local Institution - 1045
Doral, Florida 33172-2638
United States
Local Institution - 1046
Hialeah, Florida 33012-5826
United States
Local Institution - 1024
Hialeah, Florida 33012-5884
United States
Local Institution - 1052
Hialeah, Florida 33012
United States
Local Institution - 1049
Homestead, Florida 33032
United States
K2 Medical Research - Maitland
Maitland, Florida 32751-5669
United States
Local Institution - 1021
Miami, Florida 33122-1335
United States
Local Institution - 1005
Miami, Florida 33125-3724
United States
Local Institution - 1115
Miami, Florida 33135
United States
Local Institution - 1010
Miami, Florida 33137
United States
Local Institution - 1143
Miami, Florida 33145-2455
United States
Local Institution - 1009
Miami, Florida 33155-4630
United States
Local Institution - 1129
Miami, Florida 33165-3947
United States
Local Institution - 1053
Miami, Florida 33166
United States
Local Institution - 1006
Miami, Florida 33173-1474
United States
Local Institution - 1111
Miami, Florida 33173
United States
Local Institution - 1054
Miami, Florida 33186-4643
United States
Local Institution - 1042
Miami, Florida 33186-5882
United States
Local Institution - 1032
Miami Lakes, Florida 33014-5602
United States
Local Institution - 1026
Miami Springs, Florida 33166-5260
United States
Local Institution - 1027
Ocala, Florida 34470-6657
United States
Local Institution - 1012
Pensacola, Florida 32504-8608
United States
Local Institution - 1008
St. Petersburg, Florida 33713-8844
United States
University of South Florida
Tampa, Florida 33606
United States
Local Institution - 1041
Tampa, Florida 33607-4629
United States
Local Institution - 1040
The Villages, Florida 32159-8986
United States
Local Institution - 1037
Chicago, Illinois 60623
United States
Local Institution - 1018
Manhasset, New York 11030-3816
United States
Local Institution - 1-14IL3BJP
New York, New York 10003-1759
United States
Local Institution - 1030
New York, New York 10016
United States
Local Institution - 1051
New York, New York 10032-3720
United States
Local Institution - 1017
New York, New York 10032
United States
Local Institution - 1002
Staten Island, New York 10314-1607
United States
Local Institution - 1034
Stony Brook, New York 11794-0001
United States
Five Towns Neurology, PC
Woodmere, New York 11598-1739
United States
Local Institution - 1003
Canton, Ohio 44718
United States
Local Institution - 1028
Oklahoma City, Oklahoma 73104-5007
United States
Local Institution - 1016
Oklahoma City, Oklahoma 73112
United States
Local Institution - 1019
Allentown, Pennsylvania 18103
United States
Local Institution - 1035
Charleston, South Carolina 29425-8900
United States
Local Institution - 1038
Franklin, Tennessee 37067-5922
United States
Local Institution - 1022
Flower Mound, Texas 75028-2011
United States
Local Institution - 1036
Frisco, Texas 75034-6262
United States
Clinical Trial Network - 7080 Southwest Fwy
Houston, Texas 77074-2085
United States
Local Institution - 4505
Sofia, Sofia-Grad 1431
Bulgaria
Local Institution - 4502
Sofia, Sofia-Grad 1510
Bulgaria
Local Institution - 4506
Cherven Bryag, 5980
Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, 5800
Bulgaria
Medical Center Sveti Naum EOOD
Sofia, 1113
Bulgaria
Local Institution - 1-14IBHZ4D
Stara Zagora, 6003
Bulgaria
Local Institution - 4504
Vratsa, 3000
Bulgaria
Local Institution - 1-14JRHMIY
Zagreb, City of Zagreb 10000
Croatia
Local Institution - 4103
Zagreb, City of Zagreb 10000
Croatia
Local Institution - 4105
Zagreb, City of Zagreb 10000
Croatia
Polyclinic Neuron
Zagreb, City of Zagreb 10000
Croatia
Local Institution - 4101
Zagreb, City of Zagreb 10090
Croatia
Psychiatric Clinic Sveti Ivan
Zagreb, City of Zagreb 10090
Croatia
CLINTRIAL s.r.o.
Prague, Praha, Hlavní Mesto 100 00
Czechia
Local Institution - 4003
Brno, South Moravian 628 00
Czechia
Local Institution - 4001
Kutná Hora, 284 01
Czechia
A-SHINE s.r.o.
Pilsen, 301 00
Czechia
Local Institution - 1-14IL3BFV
Prague, 109 00
Czechia
Local Institution - 4004
Prague, 140 00
Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, 516 01
Czechia
Local Institution - 2501
Reims, Marne 51100
France
Local Institution - 1-14ILFZ33
Villeurbanne, Rhône 69100
France
Local Institution - 2502
Dijon, 21079
France
Local Institution - 2503
Rouen, 76000
France
Local Institution - 2401
Böblingen, Baden-Wurttemberg 71034
Germany
Local Institution - 2403
Bayreuth, Bavaria 95445
Germany
Local Institution - 2402
Homburg, Saarland 66424
Germany
Local Institution - 1-14IL3BK3
Ahmedabad, Gujarat 380061
India
Local Institution - 1-14IW4MUN
New Delhi, National Capital Territory of Delhi 110029
India
Local Institution - 1-14IW4MT8
Hyderabad, 500034
India
Local Institution - 1-14ILFYZQ
Salerno, Campania 84131
Italy
Local Institution - 2301
Rome, Lazio 00179
Italy
Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
Baggiovara, Modena 41126
Italy
Local Institution - 2307
Ponderano (Biella), Piedmont 13875
Italy
Local Institution - 2308
Florence, Tuscany 50139
Italy
Local Institution - 2304
Milan, 20121
Italy
Local Institution - 2305
Monza, 20900
Italy
Local Institution - 2302
Pisa, 56126
Italy
Local Institution - 2303
Roma, 00168
Italy
Local Institution - 2309
Roma, 00189
Italy
University Clinical Center of Serbia - Pasterova 2 - PPDS
Belgrade, Belgrade 11000
Serbia
Clinical Hospital Center Dragisa Misovic Dedinje
Belgrade, 11000
Serbia
Local Institution - 4307
Belgrade, 11000
Serbia
Military Medical Academy
Belgrade, 11000
Serbia
Military Medical Academy
Belgrade, 11000
Serbia
Local Institution - 4305
Kovin, 26220
Serbia
University Clinical Center Kragujevac
Kragujevac, 34000
Serbia
University Clinical Center Kragujevac
Kragujevac, 34000
Serbia
University Clinical Center Kragujevac
Kragujevac, 34000
Serbia
Clinical Centre of Vojvodina
Novi Sad, 21000
Serbia
Local Institution - 4311
Vršac, 26300
Serbia
Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43
Košice, Košice Region 041 90
Slovakia
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
Banská Bystrica, 974 04
Slovakia
KONZILIUM s.r.o
Dubnica nad Váhom, 018 41
Slovakia
EPAMED s.r.o
Košice, 040 01
Slovakia
Crystal Comfort, s.r.o.
Vranov nad Topľou, 093 01
Slovakia
Local Institution - 4404
Žilina, 012 07
Slovakia
Local Institution - 1-14IG4A3I
Pusan, Busan Gwangyeogsi 49241
South Korea
Local Institution - 1-14IVVWPL
Junggu, Incheon Gwang'yeogsi 22332
South Korea
Local Institution - 1-14IG4A1R
Seoul, Seoul Teugbyeolsi 05505
South Korea
Local Institution - 2205
Barcelona, 8028
Spain
Local Institution - 2207
Madrid, 28006
Spain
Complejo Asistencial Universitario de Salamanca - H. Clinico
Salamanca, 37007
Spain
Hospital Victoria Eugenia
Seville, 41009
Spain
Hospital Universitario Rio Hortega
Valladolid, 47012
Spain
Hospital Provincial de Zamora
Zamora, 49021
Spain
Hospital Viamed Montecanal
Zaragoza, 50012
Spain
Local Institution - 2103
Swindon, Wiltshire SN3 6BW
United Kingdom
Local Institution - 2105
Aberdeen, AB25 2ZL
United Kingdom
Local Institution - 2104
Motherwell, ML1 4UF
United Kingdom