A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

August 28, 2023

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2025

Conditions
Psychosis Associated With Alzheimer's Disease
Interventions
DRUG

KarXT

KarXT 20/2 mg (total daily dose \[TDD\] 60/6 mg) KarXT 30/3 mg (TDD 90/9 mg) KarXT 40/4 mg (TDD 120/12 mg) KarXT 50/5 mg (TDD 150/15 mg) KarXT 66.7/6.67 mg (TDD 200/20 mg)

DRUG

Placebo

Placebo Capsules

Trial Locations (119)

0

Local Institution - 7008, Guangzhou

Local Institution - 7202, Seongnam-si

1083

Local Institution - 4602, Budapest

3000

Local Institution - 2802, Leuven

3500

Local Institution - 2801, Hasselt

3526

Local Institution - 4603, Miskolc

7633

Local Institution - 4601, Pécs

8800

Local Institution - 2803, Roeselare

13496

Local Institution - 7207, Seongnam-si

15084

Local Institution - 6103, Pueblo Libre

21565

Local Institution - 7205, Incheon

25000

Local Institution - 1502, Saltillo Centro

26040

Local Institution - 4701, Eskişehir

30030

Local Institution - 1161, Decatur

32940

Local Institution - 1131, Viera

33032

Local Institution - 1159, Miami

33135

Local Institution - 1115, Miami

33155

Local Institution - 1009, Miami

33165

Local Institution - 1150, Miami

33175

Local Institution - 1158, Miami

33182

Local Institution - 1133, Sweetwater

34093

Local Institution - 4704, Istanbul

35210

Local Institution - 4705, Izmir

35575

Local Institution - 4703, Izmir

39232

Local Institution - 1132, Flowood

41404

Local Institution - 7208, Buk-gu

55270

Local Institution - 4702, Atakum

64460

Local Institution - 1503, Monterrey

64620

Local Institution - 1505, Monterrey

71110

Local Institution - 4801, Heraklion

80020

Local Institution - 1501, Culiacán

85286

Local Institution - 1116, Chandler

91316

Local Institution - 1151, Encino

94596

Local Institution - 1007, Walnut Creek

100025

Local Institution - 7004, Beijing

100088

Local Institution - 7005, Beijing

200030

Local Institution - 7001, Shanghai

200080

Local Institution - 7011, Shanghai

210011

Local Institution - 7013, Nanjing

230022

Local Institution - 7007, Hefei

300222

Local Institution - 7019, Tianjin

310003

Local Institution - 7017, Hangzhou

310013

Local Institution - 7010, Hangzhou

310014

Local Institution - 7006, Hangzhou

310016

Local Institution - 7020, Hangzhou

325000

Local Institution - 7018, Wenzhou

330008

Local Institution - 7012, Nanchang

400016

Local Institution - 7015, Chongqing

510120

Local Institution - 7016, Guangzhou

510260

Local Institution - 7009, Guangzhou

518118

Local Institution - 7003, Shenzhen

610000

Local Institution - 7002, Chengdu

7500000

Local Institution - 6002, Providencia

7550000

Local Institution - 6001, Las Condes

85012-2836

Local Institution - 1044, Phoenix

92805-5854

Local Institution - 1104, Anaheim

91303-1844

Local Institution - 1119, Canoga Park

93534-2839

Local Institution - 1142, Lancaster

90720-6506

Local Institution - 1117, Los Alamitos

91403-2131

Local Institution - 1103, Sherman Oaks

34711-5190

Local Institution - 1156, Clermont

33189-1230

Local Institution - 1138, Cutler Bay

33445-2581

Local Institution - 1162, Delray Beach

33122-1620

Local Institution - 1164, Doral

33912-4302

Local Institution - 1165, Fort Myers

33012-3158

Local Institution - 1155, Hialeah

33012-3618

Local Institution - 1107, Hialeah

33012-4648

Local Institution - 1120, Hialeah

33016-1814

Local Institution - 1140, Hialeah

33032-8187

Local Institution - 0150, Homestead

Local Institution - 1145, Homestead

33777-1359

Local Institution - 1127, Largo

32751-5669

Local Institution - 1039, Maitland

32751-6138

Local Institution - 1146, Maitland

33122-1721

Local Institution - 1118, Miami

33126-5683

Local Institution - 1111, Miami

33133-4231

Local Institution - 1108, Miami

33135-1601

Local Institution - 1125, Miami

33145-2455

Local Institution - 1143, Miami

33155-6630

Local Institution - 1113, Miami

33165-3947

Local Institution - 1129, Miami

33174-2950

Local Institution - 1109, Miami

33176-7947

Local Institution - 1147, Miami

33179-2537

Local Institution - 1105, Miami

33184-1412

Local Institution - 1157, Miami

33056-4000

Local Institution - 1126, Miami Gardens

33014-6435

Local Institution - 1102, Miami Lakes

34972-2568

Local Institution - 1101, Okeechobee

32806-1041

Local Institution - 1136, Orlando

32807-3555

Local Institution - 1112, Orlando

32127-2914

Local Institution - 1137, Port Orange

33607-4629

Local Institution - 1041, Tampa

33614-2700

Local Institution - 1124, Tampa

33614-2846

Local Institution - 1123, Tampa

33629-5837

Local Institution - 1110, Tampa

60123-9215

Local Institution - 1148, Elgin

70072-3083

Local Institution - 1114, Marrero

48307-2760

Local Institution - 1139, Rochester Hills

45459-4248

Local Institution - 1122, Dayton

77429-6070

Local Institution - 1106, Cypress

77074-2085

Local Institution - 1163, Houston

77450-1759

Local Institution - 1154, Katy

77477-3929

Local Institution - 1134, Stafford

127-0244

Local Institution - 6003, Antofagasta

115 21

Local Institution - 4805, Athens

115 26

Local Institution - 4803, Athens

124 62

Local Institution - 4802, Chaidari, Athens

151 23

Local Institution - 4806, Marousi

03100

Local Institution - 1506, México

20-064

Local Institution - 4206, Lublin

90-349

Local Institution - 4207, Lodz

40-156

Local Institution - 4208, Katowice

85-080

Local Institution - 4204, Bydgoszcz

40-282

Local Institution - 4205, Katowice

90-227

Local Institution - 4202, Lodz

59-330

Local Institution - 4201, Ścinawa

03080

Local Institution - 7206, Seoul

07071

Local Institution - 7203, Seoul

143-729

Local Institution - 7201, Seoul

Sponsors
All Listed Sponsors
lead

Karuna Therapeutics

INDUSTRY

NCT06126224 - A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2) | Biotech Hunter | Biotech Hunter