A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

PHASE3RecruitingINTERVENTIONAL
Enrollment

586

Participants

Timeline

Start Date

July 14, 2025

Primary Completion Date

September 11, 2028

Study Completion Date

February 23, 2029

Conditions
Alzheimer's Disease
Interventions
DRUG

KarXT

Specified dose on specified days

DRUG

KarX-EC

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Trial Locations (112)

1133

NOT_YET_RECRUITING

Local Institution - 0001, Buenos Aires

1280

NOT_YET_RECRUITING

Local Institution - 0271, Buenos Aires

2010

NOT_YET_RECRUITING

Local Institution - 0244, Sydney

2113

NOT_YET_RECRUITING

Local Institution - 0245, Macquarie Park

2217

NOT_YET_RECRUITING

Local Institution - 0279, Kogarah

3053

NOT_YET_RECRUITING

Local Institution - 0242, Carlton

5000

NOT_YET_RECRUITING

Local Institution - 0228, Córdoba

NOT_YET_RECRUITING

Local Institution - 0232, Córdoba

6005

NOT_YET_RECRUITING

Local Institution - 0243, Perth

10000

NOT_YET_RECRUITING

Local Institution - 0215, Zagreb

NOT_YET_RECRUITING

Local Institution - 0284, Zagreb

10016

NOT_YET_RECRUITING

Local Institution - 0101, New York

10029

RECRUITING

Adams Clinical Harlem, New York

10090

NOT_YET_RECRUITING

Local Institution - 0240, Zagreb

13125

NOT_YET_RECRUITING

Local Institution - 0218, Berlin

13210

NOT_YET_RECRUITING

Local Institution - 0202, Syracuse

13620

NOT_YET_RECRUITING

Local Institution - 0214, Seongnam

18600

NOT_YET_RECRUITING

Local Institution - 0222, Prague

19001

WITHDRAWN

Local Institution - 0004, Abington

20007

NOT_YET_RECRUITING

Local Institution - 0024, Washington D.C.

20122

NOT_YET_RECRUITING

Local Institution - 0249, Milan

20132

NOT_YET_RECRUITING

Local Institution - 0246, Milan

20246

NOT_YET_RECRUITING

Local Institution - 0275, Hamburg

20900

NOT_YET_RECRUITING

Local Institution - 0248, Monza

25123

NOT_YET_RECRUITING

Local Institution - 0247, Brescia

25198

NOT_YET_RECRUITING

Local Institution - 0253, Lleida

28040

NOT_YET_RECRUITING

Local Institution - 0250, Madrid

28105

RECRUITING

AMC Research, LLC, Matthews

28325

NOT_YET_RECRUITING

Local Institution - 0277, Bremen

30501

RECRUITING

Center for Advanced Research & Education, Gainesville

31000

NOT_YET_RECRUITING

Local Institution - 0216, Osijek

31008

NOT_YET_RECRUITING

Local Institution - 0252, Pamplona

31909

NOT_YET_RECRUITING

Local Institution - 0016, Columbus

32162

RECRUITING

Charter Research - Lady Lake, The Villages

32952

RECRUITING

Merritt Island Medical Research, LLC, Merritt Island

33180

RECRUITING

VIN-Julie Schwartzbard, Aventura

33462

RECRUITING

JEM Research Institute, Atlantis

34470

NOT_YET_RECRUITING

Local Institution - 0055, Ocala

34997

NOT_YET_RECRUITING

Local Institution - 0263, Stuart

37909

NOT_YET_RECRUITING

Local Institution - 0152, Knoxville

38018

NOT_YET_RECRUITING

Local Institution - 0099, Cordova

41009

NOT_YET_RECRUITING

Local Institution - 0255, Seville

41110

NOT_YET_RECRUITING

Local Institution - 0257, Larissa

43221

RECRUITING

Ohio State University, Columbus

45459

NOT_YET_RECRUITING

Local Institution - 0026, Dayton

48149

NOT_YET_RECRUITING

Local Institution - 0219, Münster

51000

NOT_YET_RECRUITING

Local Institution - 0267, Rijeka

55130

NOT_YET_RECRUITING

Local Institution - 0110, Saint Paul

55131

NOT_YET_RECRUITING

Local Institution - 0276, Mainz

60007

NOT_YET_RECRUITING

Local Institution - 0054, Elk Grove Village

60611

NOT_YET_RECRUITING

Local Institution - 0109, Chicago

61469

NOT_YET_RECRUITING

Local Institution - 0209, Gwangju

77702

NOT_YET_RECRUITING

Local Institution - 0018, Beaumont

81621

RECRUITING

Mountain Neurological Research Center, Basalt

81675

NOT_YET_RECRUITING

Local Institution - 0217, München

90804

RECRUITING

Healthy Brain Clinic, Long Beach

92374

RECRUITING

Anderson Clinical Research, Redlands

97210

RECRUITING

Summit Headlands, Portland

221005

NOT_YET_RECRUITING

Local Institution - 0287, Varanasi

500034

NOT_YET_RECRUITING

Local Institution - 0282, Hyderabad

500082

NOT_YET_RECRUITING

Local Institution - 0285, Hyderabad

560029

NOT_YET_RECRUITING

Local Institution - 0288, Bengaluru

700054

NOT_YET_RECRUITING

Local Institution - 0286, Kolkata

700282

NOT_YET_RECRUITING

Local Institution - 0268, Iași

1270244

NOT_YET_RECRUITING

Local Institution - 0230, Antofagasta

7500504

NOT_YET_RECRUITING

Local Institution - 0272, Providencia

7500710

NOT_YET_RECRUITING

Local Institution - 0094, Santiago

7560356

NOT_YET_RECRUITING

Local Institution - 0089, Santiago

8380420

NOT_YET_RECRUITING

Local Institution - 0241, Santiago

70200730

NOT_YET_RECRUITING

Local Institution - 0168, Brasília

81210310

NOT_YET_RECRUITING

Local Institution - 0180, Curitiba

02459

RECRUITING

Boston Center for Memory, Newton

08755

RECRUITING

Advanced Memory Research Institute of New Jersey, Toms River

02914

RECRUITING

Rhode Island Mood & Memory Research Institute, East Providence

B1828CKR

NOT_YET_RECRUITING

Local Institution - 0088, Banfield

X5004AOA

NOT_YET_RECRUITING

Local Institution - 0085, Córdoba

49075-000

NOT_YET_RECRUITING

Local Institution - 0266, Aracaju

05403-000

NOT_YET_RECRUITING

Local Institution - 0165, São Paulo

V1Y 1Z9

RECRUITING

OCT Research ULC, Kelowna

V6V 2L1

RECRUITING

Richmond Clinical Trials, Richmond

B3S 1N2

RECRUITING

Centricity Research Halifax Multispecialty, Halifax

K1Z 1G3

NOT_YET_RECRUITING

Local Institution - 0237, Ottawa

M3B 2S7

RECRUITING

Toronto Memory Program, Toronto

J4V 2J2

NOT_YET_RECRUITING

Local Institution - 0238, Greenfield Park

G6P 3Z8

NOT_YET_RECRUITING

Local Institution - 0239, Victoriaville

G3K 2P8

RECRUITING

ALPHA Recherche Clinique, Québec

628 00

NOT_YET_RECRUITING

Local Institution - 0227, Brno

779 00

NOT_YET_RECRUITING

Local Institution - 0225, Olomouc

301 00

NOT_YET_RECRUITING

Local Institution - 0221, Pilsen

160 00

NOT_YET_RECRUITING

Local Institution - 0223, Prague

NOT_YET_RECRUITING

Local Institution - 0224, Prague

516 01

NOT_YET_RECRUITING

Local Institution - 0226, Rychnov nad Kněžnou

681 00

NOT_YET_RECRUITING

Local Institution - 0281, Alexandroupoli

115 25

NOT_YET_RECRUITING

Local Institution - 0256, Athens

115 28

NOT_YET_RECRUITING

Local Institution - 0274, Athens

546 36

NOT_YET_RECRUITING

Local Institution - 0251, Thessaloniki

61-485

NOT_YET_RECRUITING

Local Institution - 0262, Poznan

87-100

NOT_YET_RECRUITING

Local Institution - 0261, Torun

15-404

NOT_YET_RECRUITING

Local Institution - 0280, Bialystok

80-546

NOT_YET_RECRUITING

Local Institution - 0260, Gdansk

00918

NOT_YET_RECRUITING

Local Institution - 0181, San Juan

011241

NOT_YET_RECRUITING

Local Institution - 0278, Bucharest

041914

NOT_YET_RECRUITING

Local Institution - 0269, Bucharest

NOT_YET_RECRUITING

Local Institution - 0270, Bucharest

NOT_YET_RECRUITING

Local Institution - 0273, Bucharest

07804

NOT_YET_RECRUITING

Local Institution - 0211, Gangseo-gu

03080

RECRUITING

Seoul National University Hospital, Seoul

04763

NOT_YET_RECRUITING

Local Institution - 0208, Seoul

05030

NOT_YET_RECRUITING

Local Institution - 0210, Seoul

06351

NOT_YET_RECRUITING

Local Institution - 0212, Seoul

08915

NOT_YET_RECRUITING

Local Institution - 0254, Sant Cugat del Vallès

08036

NOT_YET_RECRUITING

Local Institution - 0258, Barcelona

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT06976216 - A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease | Biotech Hunter | Biotech Hunter