A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
Start Date
8/28/2023
Completion Date
12/9/2026
Summary
This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.
Eligibility Criteria
Age Range: 55 years to 90 years
Interventions
KarXT
Placebo
Conditions
Locations
Local Institution - 1116
Chandler, Arizona 85286
United States
Local Institution - 1044
Phoenix, Arizona 85012-2836
United States
Local Institution - 1104
Anaheim, California 92805-5854
United States
Local Institution - 1119
Canoga Park, California 91303-1844
United States
Local Institution - 1151
Encino, California 91316
United States
Local Institution - 1142
Lancaster, California 93534-2839
United States
Local Institution - 1117
Los Alamitos, California 90720-6506
United States
Local Institution - 1103
Sherman Oaks, California 91403-2131
United States
Local Institution - 1007
Walnut Creek, California 94596
United States
Local Institution - 1160
Apopka, Florida 32703-5835
United States
Local Institution - 1156
Clermont, Florida 34711-5190
United States
Local Institution - 1138
Cutler Bay, Florida 33189-1230
United States
Local Institution - 1162
Delray Beach, Florida 33445-2581
United States
Local Institution - 1164
Doral, Florida 33122-1620
United States
Local Institution - 1165
Fort Myers, Florida 33912-4302
United States
Local Institution - 1155
Hialeah, Florida 33012-3158
United States
Local Institution - 1107
Hialeah, Florida 33012-3618
United States
Local Institution - 1120
Hialeah, Florida 33012-4648
United States
Local Institution - 1140
Hialeah, Florida 33016-1814
United States
Local Institution - 0150
Homestead, Florida 33032-8187
United States
Local Institution - 1145
Homestead, Florida 33032-8187
United States
Local Institution - 1127
Largo, Florida 33777-1359
United States
Local Institution - 1039
Maitland, Florida 32751-5669
United States
Local Institution - 1146
Maitland, Florida 32751-6138
United States
Local Institution - 1159
Miami, Florida 33032
United States
Local Institution - 1118
Miami, Florida 33122-1721
United States
Local Institution - 1111
Miami, Florida 33126-5683
United States
Local Institution - 1108
Miami, Florida 33133-4231
United States
Local Institution - 1125
Miami, Florida 33135-1601
United States
Local Institution - 1115
Miami, Florida 33135
United States
Local Institution - 1143
Miami, Florida 33145-2455
United States
Local Institution - 1113
Miami, Florida 33155-6630
United States
Local Institution - 1009
Miami, Florida 33155
United States
Local Institution - 1129
Miami, Florida 33165-3947
United States
Local Institution - 1150
Miami, Florida 33165
United States
Local Institution - 1109
Miami, Florida 33174-2950
United States
Local Institution - 1158
Miami, Florida 33175
United States
Local Institution - 1147
Miami, Florida 33176-7947
United States
Local Institution - 1105
Miami, Florida 33179-2537
United States
Local Institution - 1157
Miami, Florida 33184-1412
United States
Local Institution - 1126
Miami Gardens, Florida 33056-4000
United States
Local Institution - 1102
Miami Lakes, Florida 33014-6435
United States
Local Institution - 1136
Orlando, Florida 32806-1041
United States
Local Institution - 1112
Orlando, Florida 32807-3555
United States
Local Institution - 1137
Port Orange, Florida 32127-2914
United States
Health Synergy Clinical Research,LLC - Stuart
Stuart, Florida 34994
United States
Local Institution - 1133
Sweetwater, Florida 33182
United States
Local Institution - 1041
Tampa, Florida 33607-4629
United States
Local Institution - 1124
Tampa, Florida 33614-2700
United States
Local Institution - 1123
Tampa, Florida 33614-2869
United States
Local Institution - 1110
Tampa, Florida 33629-5837
United States
Local Institution - 1040
The Villages, Florida 32159-8986
United States
Local Institution - 1131
Viera, Florida 32940
United States
Local Institution - 1152
Augusta, Georgia 30912-0020
United States
Local Institution - 1141
Columbus, Georgia 31909-1693
United States
Local Institution - 1161
Decatur, Georgia 30030
United States
Local Institution - 1148
Elgin, Illinois 60123-9215
United States
Local Institution - 1114
Marrero, Louisiana 70072-3083
United States
Local Institution - 1139
Rochester Hills, Michigan 48307-2760
United States
Local Institution - 1132
Flowood, Mississippi 39232
United States
Local Institution - 1144
Las Vegas, Nevada 89106-4145
United States
Local Institution - 1153
New Hyde Park, New York 11042-2062
United States
Local Institution - 1135
Port Jefferson Station, New York 11776-3386
United States
Local Institution - 1122
Dayton, Ohio 45459-4248
United States
Local Institution - 1149
Malvern, Pennsylvania 19355-3267
United States
Local Institution - 1106
Cypress, Texas 77429-6070
United States
Local Institution - 1163
Houston, Texas 77074-2085
United States
Local Institution - 1154
Katy, Texas 77450-1759
United States
Local Institution - 1121
Red Oak, Texas 75154
United States
Local Institution - 1134
Stafford, Texas 77477-3929
United States
Local Institution - 2801
Hasselt, Limburg 3500
Belgium
Local Institution - 2802
Leuven, Vlaams Brabant 3000
Belgium
Local Institution - 2803
Roeselare, West-Vlaanderen 8800
Belgium
Local Institution - 1605
Calgary, Alberta T2N 1N4
Canada
Local Institution - 1603
Hamilton, Ontario ON L8M 1W9
Canada
Local Institution - 1602
Toronto, Ontario M5B 1W8
Canada
Local Institution - 1604
Whitby, Ontario L1N 5S9
Canada
Local Institution - 1606
Montreal, Quebec H4H 1R3
Canada
Local Institution - 1601
Verdun, Quebec H4H 1R3
Canada
Biomedica Research Group
Providencia, Santiago Metropolitan 7500000
Chile
Psicomed Estudios Medicos
Antofagasta, 1270244
Chile
Local Institution - 6001
Las Condes, 7550000
Chile
Local Institution - 7007
Hefei, Anhui 230022
China
Local Institution - 7004
Beijing, Beijing Municipality 100025
China
Local Institution - 7005
Beijing, Beijing Municipality 100088
China
Local Institution - 7015
Chongqing, Chongqing Municipality 400016
China
Local Institution - 7008
Guangzhou, Guangdong 0
China
Local Institution - 7016
Guangzhou, Guangdong 510120
China
Local Institution - 7009
Guangzhou, Guangdong 510260
China
Local Institution - 7003
Shenzhen, Guangdong 518118
China
Local Institution - 7014
Nanjing, Jiangsu 210009
China
Local Institution - 7013
Nanjing, Jiangsu 210011
China
Local Institution - 7012
Nanchang, Jiangxi 330008
China
Local Institution - 7001
Shanghai, Shanghai Municipality 200030
China
Shanghai General Hospital - North Campus
Shanghai, Shanghai Municipality 200080
China
Local Institution - 7002
Chengdu, Sichuan 610000
China
Local Institution - 7019
Tianjin, Tianjin Municipality 300222
China
Local Institution - 7017
Hangzhou, Zhejiang 310003
China
Local Institution - 7020
Hangzhou, Zhejiang 310009
China
Local Institution - 7010
Hangzhou, Zhejiang 310013
China
Local Institution - 7006
Hangzhou, Zhejiang 310014
China
Local Institution - 7018
Wenzhou, Zhejiang 325000
China
Local Institution - 4805
Athens, Attica 115 21
Greece
Local Institution - 4803
Athens, Attica 115 26
Greece
Local Institution - 4802
Chaidari, Athens, Attica 124 62
Greece
Local Institution - 4806
Marousi, Attica 151 23
Greece
Local Institution - 4801
Heraklion, 71110
Greece
Local Institution - 4601
Pécs, Baranya 7633
Hungary
Local Institution - 4602
Budapest, 1083
Hungary
Local Institution - 4603
Miskolc, 3526
Hungary
Local Institution - 1502
Saltillo Centro, Coahuila 25000
Mexico
Local Institution - 1504
Zona Urbana Río Tijuana, Estado de Baja California 22010
Mexico
Local Institution - 1507
Zapopan, Jalisco 45170
Mexico
Local Institution - 1503
Monterrey, Nuevo León 64460
Mexico
Local Institution - 1505
Monterrey, Nuevo León 64620
Mexico
Local Institution - 1501
Culiacán, Sinaloa 80020
Mexico
Local Institution - 1506
México, 03100
Mexico
Local Institution - 6102
Miraflores, Lima region 15046
Peru
Local Institution - 6103
Pueblo Libre, Lima region 15084
Peru
Local Institution - 6101
Callao, Callao 2
Peru
Local Institution - 4206
Lublin, Lublin Voivodeship 20-064
Poland
Local Institution - 4207
Lodz, Lódzkie 90-349
Poland
Local Institution - 4203
Sopot, Pomeranian Voivodeship 81-855
Poland
Local Institution - 4208
Katowice, Silesian Voivodeship 40-156
Poland
Local Institution - 4204
Bydgoszcz, 85-080
Poland
Local Institution - 4205
Katowice, 40-282
Poland
Local Institution - 4202
Lodz, 90-227
Poland
Local Institution - 4209
Siemianowice Śląskie, 41-100
Poland
Local Institution - 4201
Ścinawa, 59-330
Poland
Local Institution - 7208
Buk-gu, Daegu Gwang'yeogsi 41404
South Korea
Local Institution - 7207
Seongnam-si, Gyeonggido 13496
South Korea
Local Institution - 7205
Incheon, Incheon Gwang'yeogsi 21565
South Korea
Local Institution - 7206
Seoul, Seoul Teugbyeolsi 03080
South Korea
Local Institution - 7204
Busan, 49201
South Korea
Local Institution - 7202
Seongnam-si, 0
South Korea
Local Institution - 7203
Seoul, 07071
South Korea
Local Institution - 7201
Seoul, 143-729
South Korea
Local Institution - 2901
Geneva, Genève (fr) CH-1205
Switzerland
Local Institution - 2902
Lausanne, Vaud (fr) 1011
Switzerland
Local Institution - 4702
Atakum, Samsun 55270
Turkey (Türkiye)
Local Institution - 4701
Eskişehir, 26040
Turkey (Türkiye)
Local Institution - 4704
Istanbul, 34093
Turkey (Türkiye)
Local Institution - 4705
Izmir, 35210
Turkey (Türkiye)
Local Institution - 4703
Izmir, 35575
Turkey (Türkiye)
Local Institution - 2110
Ilford, Greater London IG1 4HP
United Kingdom
Local Institution - 2108
Swinton, Greater Manchester M27 8FF
United Kingdom
Local Institution - 2101
London, Surrey SE5 8AZ
United Kingdom
Local Institution - 2105
Aberdeen, AB25 2ZL
United Kingdom
Local Institution - 2109
Chertsey, KT16 9AU
United Kingdom
Local Institution - 2112
Edinburgh, EH4 2XU
United Kingdom
Local Institution - 2106
Leeds, LS7 3JX
United Kingdom
Local Institution - 2104
Motherwell, ML1 4UF
United Kingdom
Local Institution - 2111
Preston, PR2 9HT
United Kingdom
Local Institution - 2107
Sheffield, SouthYorkshire, s5 7JT
United Kingdom