Actively Recruiting

Phase 3
Age: 60Years - 85Years
All Genders
NCT06976216

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

Led by Bristol-Myers Squibb · Updated on 2026-05-07

586

Participants Needed

106

Research Sites

188 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of mild or moderate Alzheimer's Disease according to NIA-AA criteria
  • Mini-Mental State Examination score between 12 and 22 at screening
  • Have a caregiver who spends about 10 hours per week with the participant and can attend all study visits
  • Stable dose of acetyl choline esterase inhibitors and/or memantine for at least 12 weeks before screening, with agreement to maintain dose during study
Not Eligible

You will not qualify if you...

  • Significant or severe medical conditions including any grade of liver impairment, urinary retention, active biliary disease, moderate to severe kidney impairment, unstable hypertension, or tachycardia
  • Primary psychiatric diagnoses such as major depression, schizoaffective disorder, bipolar disorder, severe psychiatric symptoms, schizophrenia, or other chronic psychosis
  • Previous exposure to KarXT or treatment with disease-modifying anti-amyloid therapies within 6 months before screening
  • Significant pathological findings on brain MRI other than Alzheimer's Disease that could affect safety or study procedures
  • Other protocol-defined inclusion/exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 106 locations

1

Healthy Brain Clinic

Long Beach, California, United States, 90804

Actively Recruiting

2

Anderson Clinical Research

Redlands, California, United States, 92374

Actively Recruiting

3

Mountain Neurological Research Center

Basalt, Colorado, United States, 81621

Actively Recruiting

4

Georgetown University Medical Center

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

5

JEM Research Institute

Atlantis, Florida, United States, 33462

Actively Recruiting

6

VIN-Julie Schwartzbard

Aventura, Florida, United States, 33180

Actively Recruiting

7

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States, 32952

Actively Recruiting

8

Renstar Medical Research

Ocala, Florida, United States, 34470

Actively Recruiting

9

Alzheimer's Research and Treatment Center

Stuart, Florida, United States, 34997

Actively Recruiting

10

Charter Research - Lady Lake

The Villages, Florida, United States, 32162

Actively Recruiting

11

Local Institution - 0016

Columbus, Georgia, United States, 31909

Withdrawn

12

Center for Advanced Research & Education

Gainesville, Georgia, United States, 30501

Actively Recruiting

13

Re:Cognition Health - Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

14

Ascension Alexian Brothers

Elk Grove Village, Illinois, United States, 60007

Actively Recruiting

15

Boston Center for Memory

Newton, Massachusetts, United States, 02459

Actively Recruiting

16

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States, 55130

Actively Recruiting

17

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States, 08755

Actively Recruiting

18

NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

19

Local Institution - 0259

New York, New York, United States, 10029

Active, Not Recruiting

20

SUNY Upstate Medical University

Syracuse, New York, United States, 13210

Actively Recruiting

21

AMC Research, LLC

Matthews, North Carolina, United States, 28105

Actively Recruiting

22

Ohio State University

Columbus, Ohio, United States, 43221

Actively Recruiting

23

NDx Clinical Research Inc.

Dayton, Ohio, United States, 45459

Actively Recruiting

24

Summit Headlands

Portland, Oregon, United States, 97210

Actively Recruiting

25

Local Institution - 0004

Abington, Pennsylvania, United States, 19001

Withdrawn

26

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States, 02914

Actively Recruiting

27

Neurology Clinic, P.C.

Cordova, Tennessee, United States, 38018

Actively Recruiting

28

Gadolin Research

Beaumont, Texas, United States, 77702

Actively Recruiting

29

Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)

Buenos Aires, Buenos Aires F.D., Argentina, 1133

Actively Recruiting

30

Local Institution - 0271

Buenos Aires, Argentina, 1280

Not Yet Recruiting

31

Fundación Lennox - Instituto Modelo de Neurología

Córdoba, Argentina, 5000

Actively Recruiting

32

Sanatorio Morra S.A.

Córdoba, Argentina, 5000

Actively Recruiting

33

Instituto Kremer

Córdoba, Argentina, X5004AOA

Actively Recruiting

34

Southern Neurology

Kogarah, New South Wales, Australia, 2217

Actively Recruiting

35

KARA Institute for Neurological Diseases

Macquarie Park, New South Wales, Australia, 2113

Actively Recruiting

36

NeuroCentrix

Carlton, Victoria, Australia, 3053

Actively Recruiting

37

Neurodegenerative Disorders Research

Perth, Western Australia, Australia, 6005

Actively Recruiting

38

St Vincent's Hospital Sydney Limited

Darlinghurst, Australia, 2010

Actively Recruiting

39

Local Institution - 0168

Brasília, Federal District, Brazil, 70200730

Not Yet Recruiting

40

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil, 81210310

Actively Recruiting

41

Local Institution - 0266

Aracaju, Sergipe, Brazil, 49075-000

Not Yet Recruiting

42

Hospital das Clinicas FMUSP

São Paulo, Brazil, 05403-000

Actively Recruiting

43

OCT Research ULC

Kelowna, British Columbia, Canada, V1Y 1Z9

Actively Recruiting

44

Richmond Clinical Trials

Richmond, British Columbia, Canada, V6V 2L1

Actively Recruiting

45

Centricity Research Halifax Multispecialty

Halifax, Nova Scotia, Canada, B3S 1N2

Actively Recruiting

46

Ottawa Memory Clinic

Ottawa, Ontario, Canada, K1Z 1G3

Actively Recruiting

47

Toronto Memory Program

Toronto, Ontario, Canada, M3B 2S7

Actively Recruiting

48

MoCA Research and Innovation Inc.

Greenfield Park, Quebec, Canada, J4V 2J2

Actively Recruiting

49

Diex Recherche Victoriaville

Victoriaville, Quebec, Canada, G6P 3Z8

Actively Recruiting

50

ALPHA Recherche Clinique

Québec, Canada, G3K 2P8

Actively Recruiting

51

Local Institution - 0094

Santiago, Santiago Metropolitan, Chile, 7500710

Not Yet Recruiting

52

Local Institution - 0089

Santiago, Santiago Metropolitan, Chile, 7560356

Not Yet Recruiting

53

Local Institution - 0241

Santiago, Santiago Metropolitan, Chile, 8380420

Not Yet Recruiting

54

Local Institution - 0230

Antofagasta, Chile, 1270244

Not Yet Recruiting

55

Local Institution - 0215

Zagreb, City of Zagreb, Croatia, 10000

Not Yet Recruiting

56

Poliklinika Neuron

Zagreb, City of Zagreb, Croatia, 10000

Actively Recruiting

57

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia, 10090

Actively Recruiting

58

Neuro Health Centrum

Brno, Brno-město, Czechia, 628 00

Actively Recruiting

59

AGE Centrum

Olomouc, Olomouc Region, Czechia, 779 00

Actively Recruiting

60

A-Shine

Pilsen, Plzeň-město, Czechia, 301 00

Actively Recruiting

61

Neurologická Ambulance - Forbeli

Prague, Praha 6, Czechia, 160 00

Actively Recruiting

62

Neuropsychiatrie

Prague, Praha 6, Czechia, 160 00

Actively Recruiting

63

Institut neuropsychiatricke pece (INEP), Praha

Prague, Praha 8, Czechia, 18600

Actively Recruiting

64

Vestra Clinics

Rychnov nad Kněžnou, Czechia, 516 01

Actively Recruiting

65

Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany, 48149

Actively Recruiting

66

Local Institution - 0276

Mainz, Rhineland-Palatinate, Germany, 55131

Not Yet Recruiting

67

Local Institution - 0218

Berlin, Germany, 13125

Not Yet Recruiting

68

Local Institution - 0277

Bremen, Germany, 28325

Withdrawn

69

Local Institution - 0275

Hamburg, Germany, 20246

Withdrawn

70

TUM Klinikum

Munich, Germany, 81675

Actively Recruiting

71

University General Hospital of Alexandroupoli

Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece, 681 00

Actively Recruiting

72

Local Institution - 0256

Athens, Attikí, Greece, 115 25

Withdrawn

73

Aiginiteio University Hospital

Athens, Attikí, Greece, 115 28

Actively Recruiting

74

Local Institution - 0257

Larissa, Thessalía, Greece, 41110

Not Yet Recruiting

75

Local Institution - 0288

Bengaluru, Karnataka, India, 560029

Not Yet Recruiting

76

Local Institution - 0282

Hyderabad, Telangana, India, 500034

Not Yet Recruiting

77

Local Institution - 0285

Hyderabad, Telangana, India, 500082

Not Yet Recruiting

78

Local Institution - 0287

Varanasi, Uttar Pradesh, India, 221005

Not Yet Recruiting

79

Local Institution - 0286

Kolkata, West Bengal, India, 700054

Not Yet Recruiting

80

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy, 20122

Actively Recruiting

81

Ospedale San Raffaele

Milan, Lombardy, Italy, 20132

Actively Recruiting

82

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, Italy, 20900

Actively Recruiting

83

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy, 25123

Actively Recruiting

84

Local Institution - 0262

Poznan, Greater Poland Voivodeship, Poland, 61-485

Not Yet Recruiting

85

Osrodek Badan Klinicznych CLINSANTE S.C.

Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100

Actively Recruiting

86

MlynowaMed Psychiatric

Bialystok, Podlaskie Voivodeship, Poland, 15-404

Actively Recruiting

87

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland, 80-546

Actively Recruiting

88

Local Institution - 0181

San Juan, Puerto Rico, 00918

Not Yet Recruiting

89

Local Institution - 0273

Bucharest, Bucharest, Romania, 041914

Not Yet Recruiting

90

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania, 041914

Actively Recruiting

91

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania, 041914

Actively Recruiting

92

Institutul Național de Gerontologie și Geriatrie "Ana Aslan"

Bucharest, Romania, 011241

Actively Recruiting

93

Institutul de Psihiatrie Socola

Iași, Romania, 700282

Actively Recruiting

94

Chonnam National University Hospital

Gwangju, Kwangju-Kwangyǒkshi, South Korea, 61469

Actively Recruiting

95

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea, 13620

Actively Recruiting

96

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080

Actively Recruiting

97

Hanyang University Seoul Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 04763

Actively Recruiting

98

Konkuk University Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05030

Actively Recruiting

99

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06351

Actively Recruiting

100

Ewha Womans University Seoul Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 07804

Actively Recruiting

101

Hospital Victoria Eugenia

Seville, Andalusia, Spain, 41009

Actively Recruiting

102

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Barcelona [Barcelona], Spain, 08915

Actively Recruiting

103

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], Spain, 08036

Actively Recruiting

104

Hospital Universitari de Santa Maria

Lleida, Lleida [Lérida], Spain, 25198

Actively Recruiting

105

Clinica Universidad de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

106

Hospital Clinico San Carlos

Madrid, Spain, 28040

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

First line of the email MUST contain NCT # and Site #.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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