A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)

PHASE3RecruitingINTERVENTIONAL
Enrollment

380

Participants

Timeline

Start Date

August 23, 2022

Primary Completion Date

October 5, 2026

Study Completion Date

October 5, 2026

Conditions
Psychosis Associated With Alzheimer's Disease
Interventions
DRUG

KarXT

KarXT 20 mg/2 mg TID KarXT 30 mg/3 mg TID KarXT 40 mg/4 mg TID KarXT 50 mg/5 mg TID KarXT 66.7/6.67 mg TID

DRUG

Placebo

Placebo Capsules

Trial Locations (116)

1113

RECRUITING

Medical Center Sveti Naum EOOD, Sofia

1431

COMPLETED

Local Institution - 4505, Sofia

1510

COMPLETED

Local Institution - 4502, Sofia

3000

COMPLETED

Local Institution - 4504, Vratsa

5800

RECRUITING

Medical Center Medconsult Pleven OOD, Pleven

8028

COMPLETED

Local Institution - 2205, Barcelona

10000

ACTIVE_NOT_RECRUITING

Local Institution - 4102, Zagreb

COMPLETED

Local Institution - 4103, Zagreb

ACTIVE_NOT_RECRUITING

Local Institution - 4105, Zagreb

10016

WITHDRAWN

Local Institution - 1030, New York

10032

COMPLETED

Local Institution - 1017, New York

10090

RECRUITING

Klinika za psihijatriju Vrapce, Zagreb

RECRUITING

Psychiatric Clinic Sveti Ivan, Zagreb

11000

RECRUITING

University Clinical Center of Serbia - Pasterova 2 - PPDS, Belgrade

RECRUITING

Clinical Hospital Center Dragisa Misovic Dedinje, Belgrade

COMPLETED

Local Institution - 4307, Belgrade

RECRUITING

Military Medical Academy, Belgrade

RECRUITING

Military Medical Academy, Belgrade

13875

ACTIVE_NOT_RECRUITING

Local Institution - 2307, Ponderano (Biella)

18103

ACTIVE_NOT_RECRUITING

Local Institution - 1019, Allentown

20121

COMPLETED

Local Institution - 2304, Milan

20900

COMPLETED

Local Institution - 2305, Monza

21000

RECRUITING

Clinical Centre of Vojvodina, Novi Sad

21079

ACTIVE_NOT_RECRUITING

Local Institution - 2502, Dijon

26220

RECRUITING

Special Hospital for Psychiatric Diseases Kovin, Kovin

26300

COMPLETED

Local Institution - 4311, Vršac

28006

ACTIVE_NOT_RECRUITING

Local Institution - 2207, Madrid

33012

ACTIVE_NOT_RECRUITING

Local Institution - 1052, Hialeah

33032

ACTIVE_NOT_RECRUITING

Local Institution - 1049, Homestead

33135

RECRUITING

Floridian Neuroscience Institute-1901 SW 1 St, Miami

33137

COMPLETED

Local Institution - 1010, Miami

33166

RECRUITING

South Florida Research Phase I-IV, Inc. - Miami, Miami

33173

ACTIVE_NOT_RECRUITING

Local Institution - 1111, Miami

33606

ACTIVE_NOT_RECRUITING

Local Institution - 1050, Tampa

34000

RECRUITING

University Clinical Center Kragujevac, Kragujevac

RECRUITING

University Clinical Center Kragujevac, Kragujevac

RECRUITING

University Clinical Center Kragujevac, Kragujevac

37007

RECRUITING

Complejo Asistencial Universitario de Salamanca - H. Clinico, Salamanca

41009

RECRUITING

Hospital Victoria Eugenia, Seville

41126

ACTIVE_NOT_RECRUITING

Local Institution - 2306, Baggiovara

44718

WITHDRAWN

Local Institution - 1003, Canton

47012

RECRUITING

Hospital Universitario Rio Hortega, Valladolid

49021

RECRUITING

Hospital Provincial de Zamora, Zamora

50012

RECRUITING

Hospital Viamed Montecanal, Zaragoza

50139

COMPLETED

Local Institution - 2308, Florence

51100

ACTIVE_NOT_RECRUITING

Local Institution - 2501, Reims

56126

COMPLETED

Local Institution - 2302, Pisa

60623

COMPLETED

Local Institution - 1037, Chicago

66424

WITHDRAWN

Local Institution - 2402, Homburg

71034

COMPLETED

Local Institution - 2401, Böblingen

73112

COMPLETED

Local Institution - 1016, Oklahoma City

76000

COMPLETED

Local Institution - 2503, Rouen

91106

COMPLETED

Local Institution - 1043, Pasadena

92866

RECRUITING

ATP Clinical Research-302 W La Veta Ave, Orange

94596

RECRUITING

Sunwise Clinical Research, LLC - Walnut Creek - IVY - PPDS, Walnut Creek

95445

WITHDRAWN

Local Institution - 2403, Bayreuth

35209-6809

ACTIVE_NOT_RECRUITING

Local Institution - 1029, Homewood

85012-2836

COMPLETED

Local Institution - 1044, Phoenix

91436-2201

COMPLETED

Local Institution - 1033, Encino

92612-1246

WITHDRAWN

Local Institution - 1031, Irvine

92069-3595

ACTIVE_NOT_RECRUITING

Local Institution - 1047, San Marcos

80907-5302

COMPLETED

Local Institution - 1014, Colorado Springs

06905-1206

COMPLETED

Local Institution - 1013, Stamford

33487-2768

COMPLETED

Local Institution - 1011, Boca Raton

34134-4154

RECRUITING

Envision Trials LLC, Bonita Springs

34209-4687

COMPLETED

Local Institution - 1015, Bradenton

34711-5933

ACTIVE_NOT_RECRUITING

Local Institution - 1048, Clermont

32117-5532

RECRUITING

Arrow Clinical Trials, Daytona Beach

33172-2638

ACTIVE_NOT_RECRUITING

Local Institution - 1045, Doral

33012-5826

ACTIVE_NOT_RECRUITING

Local Institution - 1046, Hialeah

33012-5884

WITHDRAWN

Local Institution - 1024, Hialeah

32751-5669

RECRUITING

K2 Medical Research - Maitland, Maitland

33122-1335

RECRUITING

Premier Clinical Research Institute, Miami

33125-3724

COMPLETED

Local Institution - 1005, Miami

33145-2455

ACTIVE_NOT_RECRUITING

Local Institution - 1143, Miami

33155-4630

ACTIVE_NOT_RECRUITING

Local Institution - 1009, Miami

33165-3947

ACTIVE_NOT_RECRUITING

Local Institution - 1129, Miami

33173-1474

RECRUITING

Novel Clinical Research Center, LLC., Miami

33186-4643

RECRUITING

Coral Research Clinic & Coral Diagnostic Center, Miami

33186-5882

ACTIVE_NOT_RECRUITING

Local Institution - 1042, Miami

33014-5602

ACTIVE_NOT_RECRUITING

Local Institution - 1032, Miami Lakes

33166-5260

ACTIVE_NOT_RECRUITING

Local Institution - 1026, Miami Springs

34470-6657

WITHDRAWN

Local Institution - 1027, Ocala

32504-8608

COMPLETED

Local Institution - 1012, Pensacola

33713-8844

ACTIVE_NOT_RECRUITING

Local Institution - 1008, St. Petersburg

33607-4629

RECRUITING

K2 Medical Research - Tampa, Tampa

32159-8986

WITHDRAWN

Local Institution - 1040, The Villages

11030-3816

ACTIVE_NOT_RECRUITING

Local Institution - 1018, Manhasset

10032-3720

COMPLETED

Local Institution - 1051, New York

10314-1607

ACTIVE_NOT_RECRUITING

Local Institution - 1002, Staten Island

11794-0001

COMPLETED

Local Institution - 1034, Stony Brook

11598-1739

RECRUITING

Five Towns Neurology, PC, Woodmere

73104-5007

WITHDRAWN

Local Institution - 1028, Oklahoma City

29425-8900

ACTIVE_NOT_RECRUITING

Local Institution - 1035, Charleston

37067-5922

COMPLETED

Local Institution - 1038, Franklin

75028-2011

COMPLETED

Local Institution - 1022, Flower Mound

75034-6262

COMPLETED

Local Institution - 1036, Frisco

77074-2085

RECRUITING

Clinical Trial Network - 7080 Southwest Fwy, Houston

100 00

RECRUITING

CLINTRIAL s.r.o., Prague

628 00

WITHDRAWN

Local Institution - 4003, Brno

284 01

RECRUITING

Neuroterapie KH, s.r.o, Kutná Hora

301 00

RECRUITING

A-SHINE s.r.o., Pilsen

140 00

RECRUITING

Clinoxus s.r.o., Prague

516 01

RECRUITING

Vestra Clinics s.r.o., Rychnov nad Kněžnou

00179

COMPLETED

Local Institution - 2301, Rome

00168

ACTIVE_NOT_RECRUITING

Local Institution - 2303, Roma

00189

COMPLETED

Local Institution - 2309, Roma

041 90

RECRUITING

Univerzitna nemocnica L Pasteura Kosice-Rastislavova 43, Košice

974 04

RECRUITING

MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o., Banská Bystrica

018 41

RECRUITING

KONZILIUM s.r.o, Dubnica nad Váhom

040 01

RECRUITING

EPAMED s.r.o, Košice

093 01

RECRUITING

Crystal Comfort, s.r.o., Vranov nad Topľou

012 07

WITHDRAWN

Local Institution - 4404, Žilina

SN3 6BW

WITHDRAWN

Local Institution - 2103, Swindon

AB25 2ZL

WITHDRAWN

Local Institution - 2105, Aberdeen

ML1 4UF

WITHDRAWN

Local Institution - 2104, Motherwell

Sponsors
All Listed Sponsors
lead

Karuna Therapeutics

INDUSTRY

NCT05511363 - A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1) | Biotech Hunter | Biotech Hunter