A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

PHASE3RecruitingINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

July 16, 2025

Primary Completion Date

November 3, 2028

Study Completion Date

November 13, 2028

Conditions
Alzheimer Disease
Interventions
DRUG

Xanomeline/Trospium Chloride Capsule

Specified dose on specified days

DRUG

Xanomeline Enteric Capsule

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Trial Locations (137)

0

NOT_YET_RECRUITING

Local Institution - 2250, Győr

1033

NOT_YET_RECRUITING

Local Institution - 2256, Budapest

1036

NOT_YET_RECRUITING

Local Institution - 2255, Budapest

1058

NOT_YET_RECRUITING

Local Institution - 2005, Ciudad Autonoma de Buenos Aires

1083

WITHDRAWN

Local Institution - 2251, Budapest

1088

NOT_YET_RECRUITING

Local Institution - 2253, Budapest

1133

NOT_YET_RECRUITING

Local Institution - 2006, Buenos Aires

1199

NOT_YET_RECRUITING

Local Institution - 2004, Buenos Aires

3200

NOT_YET_RECRUITING

Local Institution - 2254, Gyöngyös

4032

NOT_YET_RECRUITING

Local Institution - 2252, Debrecen

5000

NOT_YET_RECRUITING

Local Institution - 2000, Córdoba

NOT_YET_RECRUITING

Local Institution - 2002, Córdoba

5502

NOT_YET_RECRUITING

Local Institution - 2001, Mendoza

6300

NOT_YET_RECRUITING

Local Institution - 2257, Kalocsa

10312

RECRUITING

Richmond Behavioral Associates, Staten Island

18600

NOT_YET_RECRUITING

Local Institution - 2106, Prague

20149

NOT_YET_RECRUITING

Local Institution - 2353, Milan

20708

NOT_YET_RECRUITING

Local Institution - 2555, Smila

21037

NOT_YET_RECRUITING

Local Institution - 2551, Vinnytsia

22332

RECRUITING

Inha University Hospital, Incheon

25011

NOT_YET_RECRUITING

Local Institution - 2550, Kropyvnytskyi

25123

NOT_YET_RECRUITING

Local Institution - 2356, Brescia

26655

NOT_YET_RECRUITING

Local Institution - 2206, Westerstede

28557

RECRUITING

West Clinical Research, Morehead City

30328

RECRUITING

Agile Clinical Research Trials, LLC, Atlanta

31000

NOT_YET_RECRUITING

Local Institution - 2150, Toulouse

31340

NOT_YET_RECRUITING

Local Institution - 2559, Skarzhyntsi

32806

NOT_YET_RECRUITING

Local Institution - 2634, Orlando

33012

NOT_YET_RECRUITING

Local Institution - 2626, Hialeah

33032

NOT_YET_RECRUITING

Local Institution - 2606, Homestead

33122

NOT_YET_RECRUITING

Local Institution - 2636, Doral

33137

NOT_YET_RECRUITING

Local Institution - 2633, Miami

33165

NOT_YET_RECRUITING

Local Institution - 2637, Miami

33629

RECRUITING

IPTB Clinical Research, Tampa

34207

NOT_YET_RECRUITING

Local Institution - 2624, Bradenton

36013

NOT_YET_RECRUITING

Local Institution - 2557, Poltava

39402

NOT_YET_RECRUITING

Local Institution - 2629, Hattiesburg

40221

NOT_YET_RECRUITING

Local Institution - 2201, Düsseldorf

41404

RECRUITING

Kyungpook National University Chilgok Hospital, Deagu

43005

NOT_YET_RECRUITING

Local Institution - 2560, Lutsk

45242

RECRUITING

Velocity Clinical Research - Blue Ash, Blue Ash

48105

RECRUITING

Michigan Clinical Research Institute PC, Ann Arbor

49100

NOT_YET_RECRUITING

Local Institution - 2302, Petch Tikva

49115

NOT_YET_RECRUITING

Local Institution - 2554, Dnipro

53226

NOT_YET_RECRUITING

Local Institution - 2610, Milwaukee

55130

NOT_YET_RECRUITING

Local Institution - 2630, Saint Paul

56126

NOT_YET_RECRUITING

Local Institution - 2350, Pisa

59037

NOT_YET_RECRUITING

Local Institution - 2153, Lille

64711

NOT_YET_RECRUITING

Local Institution - 2203, Erbach im Odenwald

65006

NOT_YET_RECRUITING

Local Institution - 2568, Odesa

65721

NOT_YET_RECRUITING

Local Institution - 2603, Ozark

67091

NOT_YET_RECRUITING

Local Institution - 2155, Strasbourg

67512

NOT_YET_RECRUITING

Local Institution - 2567, Oleksandrivka

69100

NOT_YET_RECRUITING

Local Institution - 2151, Villeurbanne

75006

RECRUITING

Epic Medical Research, LLC - Carrolton, Carrollton

75010

NOT_YET_RECRUITING

Local Institution - 2152, Paris

75150

RECRUITING

Epic Medical Research, LLC - Mesquite, Mesquite

77065

NOT_YET_RECRUITING

Local Institution - 2605, Cypress

78229

NOT_YET_RECRUITING

Local Institution - 2623, San Antonio

79021

NOT_YET_RECRUITING

Local Institution - 2552, Lviv

79035

NOT_YET_RECRUITING

Local Institution - 2558, Lviv

NOT_YET_RECRUITING

Local Institution - 2569, Lviv

80131

NOT_YET_RECRUITING

Local Institution - 2351, Napoli

80907

NOT_YET_RECRUITING

Local Institution - 2635, Colorado Springs

81621

WITHDRAWN

Local Institution - 2601, Basalt

84010

RECRUITING

Pantheon Clinical Research, LLC, Bountiful

86077

WITHDRAWN

Local Institution - 2355, Isernia

87042

NOT_YET_RECRUITING

Local Institution - 2156, Limoges

89030

NOT_YET_RECRUITING

Local Institution - 2628, Las Vegas

90040

NOT_YET_RECRUITING

Local Institution - 2625, Long Beach

90805

NOT_YET_RECRUITING

Local Institution - 2607, Long Beach

91105

NOT_YET_RECRUITING

Local Institution - 2613, Pasadena

91120

NOT_YET_RECRUITING

Local Institution - 2301, Jerusalem

91307

RECRUITING

Alliance Clinical -West Hills, West Hills

92108

NOT_YET_RECRUITING

Local Institution - 2614, San Diego

94558

NOT_YET_RECRUITING

Local Institution - 2627, Napa

98034

NOT_YET_RECRUITING

Local Institution - 2638, Kirkland

1270244

NOT_YET_RECRUITING

Local Institution - 2053, Antofagasta

2511433

NOT_YET_RECRUITING

Local Institution - 2055, Viña del Mar

NOT_YET_RECRUITING

Local Institution - 2054, Vitacura

4244916

NOT_YET_RECRUITING

Local Institution - 2303, Netanya

5262000

NOT_YET_RECRUITING

Local Institution - 2305, Ramat Gan

5265601

NOT_YET_RECRUITING

Local Institution - 2300, Ramat Gan

7500710

NOT_YET_RECRUITING

Local Institution - 2051, Santiago

7560356

NOT_YET_RECRUITING

Local Institution - 2050, Santiago

7590653

NOT_YET_RECRUITING

Local Institution - 2304, Rishon Le'Tzion

8330024

NOT_YET_RECRUITING

Local Institution - 2052, Santiago

85224-6231

NOT_YET_RECRUITING

Local Institution - 2609, Chandler

85226-3732

NOT_YET_RECRUITING

Local Institution - 2631, Chandler

06851

NOT_YET_RECRUITING

Local Institution - 2632, Norwalk

34134-4154

RECRUITING

Envision Trials LLC, Bonita Springs

01608

RECRUITING

Vitalix Clinical, Worcester

X5003DCE

NOT_YET_RECRUITING

Local Institution - 2003, Córdoba

779 00

NOT_YET_RECRUITING

Local Institution - 2107, Olomouc

160 00

NOT_YET_RECRUITING

Local Institution - 2100, Prague

628 00

NOT_YET_RECRUITING

Local Institution - 2103, Brno

565 01

NOT_YET_RECRUITING

Local Institution - 2101, Choceň

301 00

NOT_YET_RECRUITING

Local Institution - 2104, Pilsen

100 000

WITHDRAWN

Local Institution - 2102, Prague

100 00

WITHDRAWN

Local Institution - 2105, Prague

516 01

NOT_YET_RECRUITING

Local Institution - 2108, Rychnov nad Kněžnou

06120

NOT_YET_RECRUITING

Local Institution - 2205, Halle

00185

NOT_YET_RECRUITING

Local Institution - 2354, Rome

00189

NOT_YET_RECRUITING

Local Institution - 2352, Rome

00168

NOT_YET_RECRUITING

Local Institution - 2357, Roma

85-163

NOT_YET_RECRUITING

Local Institution - 2454, Bydgoszcz

41-500

NOT_YET_RECRUITING

Local Institution - 2456, Chorzów

40-146

NOT_YET_RECRUITING

Local Institution - 2455, Katowice

20-064

NOT_YET_RECRUITING

Local Institution - 2451, Lublin

NOT_YET_RECRUITING

Local Institution - 2452, Lublin

61-485

NOT_YET_RECRUITING

Local Institution - 2450, Poznan

96-500

NOT_YET_RECRUITING

Local Institution - 2453, Sochaczew

00917

NOT_YET_RECRUITING

Local Institution - 2641, San Juan

00918-4502

NOT_YET_RECRUITING

Local Institution - 2640, San Juan

00918

NOT_YET_RECRUITING

Local Institution - 2639, San Juan

03080

RECRUITING

Seoul National University Hospital, Seoul

05030

RECRUITING

Konkuk University Medical Center, Seoul

06351

WITHDRAWN

Local Institution - 2406, Seoul

405-760

NOT_YET_RECRUITING

Local Institution - 2409, Incheon

05505

NOT_YET_RECRUITING

Local Institution - 2402, Seoul

06273

NOT_YET_RECRUITING

Local Institution - 2408, Seoul

07061

NOT_YET_RECRUITING

Local Institution - 2405, Seoul

07345

NOT_YET_RECRUITING

Local Institution - 2404, Seoul

08631

NOT_YET_RECRUITING

Local Institution - 2556, Hlevakha

NOT_YET_RECRUITING

Local Institution - 2566, Hlevakha

04080

NOT_YET_RECRUITING

Local Institution - 2553, Kyiv

01030

NOT_YET_RECRUITING

Local Institution - 2565, Kyiv

PR2 9HT

NOT_YET_RECRUITING

Local Institution - 2505, Preston

KT16 9AU

NOT_YET_RECRUITING

Local Institution - 2508, Chertsey

CB21 5EF

NOT_YET_RECRUITING

Local Institution - 2502, Cambridge

SE5 8AZ

NOT_YET_RECRUITING

Local Institution - 2501, London

W12 0NN

NOT_YET_RECRUITING

Local Institution - 2500, London

ML1 4UF

RECRUITING

NeuroClin Glasgow, Motherwell

TR15 3QE

NOT_YET_RECRUITING

Local Institution - 2507, Redruth

S5 7JT

NOT_YET_RECRUITING

Local Institution - 2504, Sheffield

ST16 3SR

NOT_YET_RECRUITING

Local Institution - 2509, Stafford

WV4 5HN

NOT_YET_RECRUITING

Local Institution - 2503, Wolverhampton

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT07011745 - A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2) | Biotech Hunter | Biotech Hunter