A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

PHASE3RecruitingINTERVENTIONAL
Enrollment

586

Participants

Timeline

Start Date

July 21, 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 (120)

0

NOT_YET_RECRUITING

Local Institution - 0042, Bucharest

1181

NOT_YET_RECRUITING

Local Institution - 0029, ABB

3079

NOT_YET_RECRUITING

Local Institution - 0054, Ivanhoe

4072

NOT_YET_RECRUITING

Local Institution - 0055, Saint Lucia

4222

NOT_YET_RECRUITING

Local Institution - 0056, Southport

4556

NOT_YET_RECRUITING

Local Institution - 0053, Sippy Downs

5000

NOT_YET_RECRUITING

Local Institution - 0028, Córdoba

5502

NOT_YET_RECRUITING

Local Institution - 0026, Mendoza

11042

WITHDRAWN

Local Institution - 0078, Lake Success

12208

RECRUITING

Neurological Associates Albany, Albany

13005

NOT_YET_RECRUITING

Local Institution - 0015, Marseille

14203

NOT_YET_RECRUITING

Local Institution - 0087, Buffalo

14226

NOT_YET_RECRUITING

Local Institution - 0068, Amherst

19462

RECRUITING

Keystone Clinical Studies, Plymouth Meeting

20014

NOT_YET_RECRUITING

Local Institution - 0043, Donostia / San Sebastian

20520

NOT_YET_RECRUITING

Local Institution - 0009, Turku

26504

NOT_YET_RECRUITING

Local Institution - 0109, Pátrai

28006

NOT_YET_RECRUITING

Local Institution - 0048, Madrid

28041

NOT_YET_RECRUITING

Local Institution - 0045, Madrid

28223

NOT_YET_RECRUITING

Local Institution - 0047, Pozuelo de Alarcón

31000

NOT_YET_RECRUITING

Local Institution - 0013, Toulouse

32159

RECRUITING

K2 MEDICAL Research THE VILLAGES, Lady Lake

32216

RECRUITING

Jacksonville Center for Clinical Research, Jacksonville

33009

NOT_YET_RECRUITING

Local Institution - 0086, Hallandale

33076

NOT_YET_RECRUITING

Local Institution - 0012, Bordeaux

33414

NOT_YET_RECRUITING

Local Institution - 0089, Wellington

33613

NOT_YET_RECRUITING

Local Institution - 0084, Tampa

33912

RECRUITING

Neuropsychiatric Research Center of Southwest Florida, Fort Myers

34239

NOT_YET_RECRUITING

Local Institution - 0082, Sarasota

35000

NOT_YET_RECRUITING

Local Institution - 0019, Rennes

37075

NOT_YET_RECRUITING

Local Institution - 0023, Göttingen

39008

NOT_YET_RECRUITING

Local Institution - 0046, Santander

39401

RECRUITING

Private Practice - Dr. Ronald Louis Schwartz, Hattiesburg

46017

NOT_YET_RECRUITING

Local Institution - 0044, Valencia

46256

RECRUITING

Josephson Wallack Munshower Neurology, PC, Indianapolis

48334

RECRUITING

QUEST Research Institute, Farmington Hills

50937

NOT_YET_RECRUITING

Local Institution - 0002, Cologne

54035

NOT_YET_RECRUITING

Local Institution - 0016, Nancy

59037

NOT_YET_RECRUITING

Local Institution - 0021, Lille

60640

RECRUITING

Great Lakes Clinical Trials - Andersonville, Chicago

61348

NOT_YET_RECRUITING

Local Institution - 0024, Bad Homburg

62702

RECRUITING

Southern Illinois University School of Medicine, Springfield

67091

NOT_YET_RECRUITING

Local Institution - 0018, Strasbourg

69500

NOT_YET_RECRUITING

Local Institution - 0020, Bron

69655

WITHDRAWN

Local Institution - 0017, Villefranche-sur-Saône

70210

NOT_YET_RECRUITING

Local Institution - 0008, Kuopio

71100

NOT_YET_RECRUITING

Local Institution - 0058, Foggia

75010

NOT_YET_RECRUITING

Local Institution - 0014, Paris

75013

NOT_YET_RECRUITING

Local Institution - 0036, Paris

NOT_YET_RECRUITING

Local Institution - 0102, Paris

75231

NOT_YET_RECRUITING

Local Institution - 0081, Dallas

78681

RECRUITING

Central Texas Neurology Consultants, PA, Round Rock

80131

NOT_YET_RECRUITING

Local Institution - 0057, Napoli

80539

NOT_YET_RECRUITING

Local Institution - 0004, Munich

80919

NOT_YET_RECRUITING

Local Institution - 0088, Colorado Springs

89081

NOT_YET_RECRUITING

Local Institution - 0003, Ulm

90100

NOT_YET_RECRUITING

Local Institution - 0022, Oulu

90301

RECRUITING

Inglewood Clinical, Inglewood

92103

WITHDRAWN

Local Institution - 0069, San Diego

92614

RECRUITING

Irvine Clinical Research, Irvine

92835

RECRUITING

Fullerton Neurology and Headache Center, Fullerton

94304

NOT_YET_RECRUITING

Local Institution - 0083, Palo Alto

98057

NOT_YET_RECRUITING

Local Institution - 0076, Renton

507190

NOT_YET_RECRUITING

Local Institution - 0041, Sanpetru /Brasov

900675

NOT_YET_RECRUITING

Local Institution - 0113, Constanța

02472

NOT_YET_RECRUITING

Local Institution - 0080, Watertown

07450

WITHDRAWN

Local Institution - 0119, Ridgewood

07081

NOT_YET_RECRUITING

Local Institution - 0094, Springfield

07764

NOT_YET_RECRUITING

Local Institution - 0075, West Long Branch

X5006CBI

NOT_YET_RECRUITING

Local Institution - 0027, Córdoba

C1428AQK

NOT_YET_RECRUITING

Local Institution - 0025, Buenos Aires

X5003DCE

NOT_YET_RECRUITING

Local Institution - 0030, Córdoba

60135-237

NOT_YET_RECRUITING

Local Institution - 0115, Fortaleza

87015-180

NOT_YET_RECRUITING

Local Institution - 0101, Maringá

22270-060

NOT_YET_RECRUITING

Local Institution - 0099, Rio de Janeiro

01228-000

NOT_YET_RECRUITING

Local Institution - 0100, São Paulo

00180

NOT_YET_RECRUITING

Local Institution - 0007, Helsinki

NOT_YET_RECRUITING

Local Institution - 0006, Helsinki

09111

NOT_YET_RECRUITING

Local Institution - 0001, Chemnitz

124 62

NOT_YET_RECRUITING

Local Institution - 0060, Chaïdári

151 23

NOT_YET_RECRUITING

Local Institution - 0061, Marousi

455 00

NOT_YET_RECRUITING

Local Institution - 0059, Ioannina

546 36

NOT_YET_RECRUITING

Local Institution - 0110, Thessaloniki

00168

NOT_YET_RECRUITING

Local Institution - 0067, Roma

263-0043

NOT_YET_RECRUITING

Local Institution - 0121, Inage

271-0047

NOT_YET_RECRUITING

Local Institution - 0123, Matsudo

761-0701

NOT_YET_RECRUITING

Local Institution - 0120, Kita

210-0852

NOT_YET_RECRUITING

Local Institution - 0122, Kawasaki

211-8533

NOT_YET_RECRUITING

Local Institution - 0106, Kawasaki

396-0033

NOT_YET_RECRUITING

Local Institution - 0038, Ina

945-0847

NOT_YET_RECRUITING

Local Institution - 0033, Kashiwazaki

710-0813

NOT_YET_RECRUITING

Local Institution - 0034, Kurashiki

556-0015

NOT_YET_RECRUITING

Local Institution - 0035, Osaka

842-0192

NOT_YET_RECRUITING

Local Institution - 0031, Yoshinogari-cho, Kanzaki-gun

351-0111

WITHDRAWN

Local Institution - 0037, Wako

NOT_YET_RECRUITING

Local Institution - 0112, Wako

616-8255

NOT_YET_RECRUITING

Local Institution - 0107, Kyoto

5223 LA

NOT_YET_RECRUITING

Local Institution - 0011, 's-Hertogenbosch

1081 GN

NOT_YET_RECRUITING

Local Institution - 0096, Amsterdam

8025 AZ

NOT_YET_RECRUITING

Local Institution - 0098, Zwolle

32-600

NOT_YET_RECRUITING

Local Institution - 0066, Oświęcim

54-239

NOT_YET_RECRUITING

Local Institution - 0064, Wroclaw

20-064

NOT_YET_RECRUITING

Local Institution - 0108, Lublin

40-353

NOT_YET_RECRUITING

Local Institution - 0065, Katowice

2560-280

NOT_YET_RECRUITING

Local Institution - 0050, Torres Vedras

4464-513

NOT_YET_RECRUITING

Local Institution - 0104, Matosinhos Municipality

4710-243

NOT_YET_RECRUITING

Local Institution - 0051, Braga

3000 075

NOT_YET_RECRUITING

Local Institution - 0049, Coimbra

4800-055

NOT_YET_RECRUITING

Local Institution - 0063, Guimarães

4050-014

NOT_YET_RECRUITING

Local Institution - 0052, Porto

00961

RECRUITING

SCB Research Center, Bayamón

041914

NOT_YET_RECRUITING

Local Institution - 0039, Bucharest

NOT_YET_RECRUITING

Local Institution - 0040, Bucharest

08028

NOT_YET_RECRUITING

Local Institution - 0062, Barcelona

M13 9WL

NOT_YET_RECRUITING

Local Institution - 0097, Manchester

LS25 7JN

NOT_YET_RECRUITING

Local Institution - 0111, Kippax

SE5 8AZ

NOT_YET_RECRUITING

Local Institution - 0116, London

EH4 2XU

NOT_YET_RECRUITING

Local Institution - 0103, Edinburgh

OX3 7JX

NOT_YET_RECRUITING

Local Institution - 0010, Oxford

B16 8LT

RECRUITING

Re:Cognition Health - Birmingham, Birmingham

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT06976203 - A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2) | Biotech Hunter | Biotech Hunter