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-1)

PHASE3RecruitingINTERVENTIONAL
Enrollment

352

Participants

Timeline

Start Date

July 10, 2025

Primary Completion Date

November 24, 2028

Study Completion Date

December 8, 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 (140)

112

NOT_YET_RECRUITING

Local Institution - 1750, Taipei

333

NOT_YET_RECRUITING

Local Institution - 1752, Taoyuan District

704

NOT_YET_RECRUITING

Local Institution - 1751, Tainan, Taiana

1113

NOT_YET_RECRUITING

Local Institution - 1100, Sofia

1900

NOT_YET_RECRUITING

Local Institution - 1001, La Plata

3049

NOT_YET_RECRUITING

Local Institution - 1401, Coimbra

5000

NOT_YET_RECRUITING

Local Institution - 1004, Córdoba

5004

NOT_YET_RECRUITING

Local Institution - 1005, Córdoba

5006

NOT_YET_RECRUITING

Local Institution - 1000, Córdoba

5800

NOT_YET_RECRUITING

Local Institution - 1101, Pleven

7200

NOT_YET_RECRUITING

Local Institution - 1103, Razgrad

8221

NOT_YET_RECRUITING

Local Institution - 1504, Terrassa

9020

NOT_YET_RECRUITING

Local Institution - 1102, Varna

10000

NOT_YET_RECRUITING

Local Institution - 1550, Zagreb

NOT_YET_RECRUITING

Local Institution - 1553, Zagreb

10200

NOT_YET_RECRUITING

Local Institution - 1361, Mexico City

11096

NOT_YET_RECRUITING

Local Institution - 1610, Inwood

11527

NOT_YET_RECRUITING

Local Institution - 1202, Athens

NOT_YET_RECRUITING

Local Institution - 1203, Athens

12553

NOT_YET_RECRUITING

Local Institution - 1656, New Windsor

14090

NOT_YET_RECRUITING

Local Institution - 1363, Mexico City

14269

NOT_YET_RECRUITING

Local Institution - 1360, Mexico City

15125

NOT_YET_RECRUITING

Local Institution - 1207, Athens

20877

RECRUITING

CBH Health, Gaithersburg

25000

NOT_YET_RECRUITING

Local Institution - 1355, Saltillo

26504

NOT_YET_RECRUITING

Local Institution - 1200, Pátrai

28006

NOT_YET_RECRUITING

Local Institution - 1508, Madrid

28040

NOT_YET_RECRUITING

Local Institution - 1505, Madrid

28112

NOT_YET_RECRUITING

Local Institution - 1601, Monroe

29010

NOT_YET_RECRUITING

Local Institution - 1502, Málaga

29205

WITHDRAWN

Local Institution - 1652, Columbia

NOT_YET_RECRUITING

Local Institution - 1653, Columbia

31008

NOT_YET_RECRUITING

Local Institution - 1507, Pamplona

31406

NOT_YET_RECRUITING

Local Institution - 1661, Savannah

32127

RECRUITING

Progressive Medical Research, Port Orange

32751

NOT_YET_RECRUITING

Local Institution - 1622, Maitland

NOT_YET_RECRUITING

Local Institution - 1631, Maitland

32807

RECRUITING

Combined Research Orlando (CRO), Orlando

33122

NOT_YET_RECRUITING

Local Institution - 1602, Miami

33135

NOT_YET_RECRUITING

Local Institution - 1618, Miami

33166

RECRUITING

Hope Research Network - Miami, Miami

33186

RECRUITING

Nuovida Research Center, Miami

34471

NOT_YET_RECRUITING

Local Institution - 1608, Ocala

37007

NOT_YET_RECRUITING

Local Institution - 1500, Salamanca

41009

NOT_YET_RECRUITING

Local Institution - 1503, Seville

42000

NOT_YET_RECRUITING

Local Institution - 1552, Varaždin

45459

NOT_YET_RECRUITING

Local Institution - 1659, Centerville

45500

NOT_YET_RECRUITING

Local Institution - 1201, Ioannina

47012

NOT_YET_RECRUITING

Local Institution - 1506, Valladolid

48085

RECRUITING

Oakland Medical Research, Troy

48302

NOT_YET_RECRUITING

Local Institution - 1665, Bloomfield Hills

48993

NOT_YET_RECRUITING

Local Institution - 1510, Getxo

50012

NOT_YET_RECRUITING

Local Institution - 1501, Zaragoza

51000

NOT_YET_RECRUITING

Local Institution - 1554, Rijeka

54055

NOT_YET_RECRUITING

Local Institution - 1352, Tlalnepantla

54645

NOT_YET_RECRUITING

Local Institution - 1204, Thessaloniki

64710

NOT_YET_RECRUITING

Local Institution - 1364, Monterrey

66460

NOT_YET_RECRUITING

Local Institution - 1350, Monterrey

70072

NOT_YET_RECRUITING

Local Institution - 1655, Marrero

74136

RECRUITING

Central States Research, Tulsa

78216

NOT_YET_RECRUITING

Local Institution - 1362, San Luis Potosí City

79912

NOT_YET_RECRUITING

Local Institution - 1643, El Paso

80907

WITHDRAWN

Local Institution - 1630, Colorado Springs

83301

NOT_YET_RECRUITING

Local Institution - 1753, Kaohsiung Niao Sung Dist

84107

NOT_YET_RECRUITING

Local Institution - 1641, Salt Lake City

85258

RECRUITING

Imaging Endpoints, Scottsdale

89119

RECRUITING

Redbird Research, Las Vegas

90505

NOT_YET_RECRUITING

Local Institution - 1639, Torrance

91767

NOT_YET_RECRUITING

Local Institution - 1662, Pomona

92037

RECRUITING

Kaizen Brain Center, La Jolla

92805

NOT_YET_RECRUITING

Local Institution - 1657, Anaheim

94596

RECRUITING

Sunwise Clinical Research, Walnut Creek

98122

NOT_YET_RECRUITING

Local Institution - 1644, Seattle

99201

NOT_YET_RECRUITING

Local Institution - 1654, Spokane

100229

NOT_YET_RECRUITING

Local Institution - 1754, Taipei

110029

NOT_YET_RECRUITING

Local Institution - 1253, New Delhi

221005

NOT_YET_RECRUITING

Local Institution - 1254, Varanasi

380060

NOT_YET_RECRUITING

Local Institution - 1255, Ahmedabad

500082

NOT_YET_RECRUITING

Local Institution - 1252, Hyderabad

507190

NOT_YET_RECRUITING

Local Institution - 1460, Sanpetru /Brasov

550082

NOT_YET_RECRUITING

Local Institution - 1462, Sibiu

700054

NOT_YET_RECRUITING

Local Institution - 1250, Kolkata

700282

NOT_YET_RECRUITING

Local Institution - 1457, Iași

900123

NOT_YET_RECRUITING

Local Institution - 1461, Constanța

2570003

NOT_YET_RECRUITING

Local Institution - 1301, Hadano

70200730

NOT_YET_RECRUITING

Local Institution - 1051, Brasília

90560032

NOT_YET_RECRUITING

Local Institution - 1054, Porto Alegre

02035-1309

NOT_YET_RECRUITING

Local Institution - 1663, Foxborough

02459

RECRUITING

Boston Center for Memory, Newton

02747

RECRUITING

Mayflower Clinical Research, South Dartmouth

01151

NOT_YET_RECRUITING

Local Institution - 1660, Springfield

07748

NOT_YET_RECRUITING

Local Institution - 1647, Middletown

08540

NOT_YET_RECRUITING

Local Institution - 1664, Princeton

11598-1739

WITHDRAWN

Local Institution - 1645, Woodmere

NOT_YET_RECRUITING

Local Institution - 1658, Woodmere

05201-9810

NOT_YET_RECRUITING

Local Institution - 1646, Bennington

B7602CBM

NOT_YET_RECRUITING

Local Institution - 1002, Mar del Plata

S2000

NOT_YET_RECRUITING

Local Institution - 1006, Rosario

C1428AQK

NOT_YET_RECRUITING

Local Institution - 1003, Buenos Aires

80230-130

NOT_YET_RECRUITING

Local Institution - 1052, Curitiba

80240-280

NOT_YET_RECRUITING

Local Institution - 1053, Curitiba

90430-001

NOT_YET_RECRUITING

Local Institution - 1058, Porto Alegre

13060-080

NOT_YET_RECRUITING

Local Institution - 1057, Campinas

04020-060

NOT_YET_RECRUITING

Local Institution - 1056, São Paulo

22270-060

NOT_YET_RECRUITING

Local Institution - 1050, Rio de Janeiro

01228-000

NOT_YET_RECRUITING

Local Institution - 1055, São Paulo

ON L8M 1W9

NOT_YET_RECRUITING

Local Institution - 1153, Hamilton

N6A 5A5

NOT_YET_RECRUITING

Local Institution - 1155, London

N6A 5W9

WITHDRAWN

Local Institution - 1755, London

M4N 3M5

NOT_YET_RECRUITING

Local Institution - 1151, Toronto

M6J 1H4

NOT_YET_RECRUITING

Local Institution - 1154, Toronto

L1N 5S9

NOT_YET_RECRUITING

Local Institution - 1152, Whitby

H4A 3T2

NOT_YET_RECRUITING

Local Institution - 1150, Montreal

HR-21000

NOT_YET_RECRUITING

Local Institution - 1551, Split

115 26

NOT_YET_RECRUITING

Local Institution - 1205, Athens

106 79

NOT_YET_RECRUITING

Local Institution - 1206, Athens

500 034

NOT_YET_RECRUITING

Local Institution - 1251, Hyderabad

110 095

NOT_YET_RECRUITING

Local Institution - 1256, Delhi

213-8507

NOT_YET_RECRUITING

Local Institution - 1307, Kawasaki

590-0018

NOT_YET_RECRUITING

Local Institution - 1304, Sakai

842-0192

NOT_YET_RECRUITING

Local Institution - 1303, Kanzaki-Gun Yoshinogari-Cho

847-0031

NOT_YET_RECRUITING

Local Institution - 1300, Karatsu-shi

113-8603

NOT_YET_RECRUITING

Local Institution - 1305, Bunkyo-ku

819-0037

NOT_YET_RECRUITING

Local Institution - 1302, Fukuoka

700-8557

NOT_YET_RECRUITING

Local Institution - 1306, Okayama

01120

NOT_YET_RECRUITING

Local Institution - 1356, Mexico City

4835-044

NOT_YET_RECRUITING

Local Institution - 1402, Guimarães

1649-035

NOT_YET_RECRUITING

Local Institution - 1404, Lisbon

4464-513

NOT_YET_RECRUITING

Local Institution - 1403, Senhora da Hora

2560-280

NOT_YET_RECRUITING

Local Institution - 1400, Torres Vedras

041919

NOT_YET_RECRUITING

Local Institution - 1450, Bucharest

NOT_YET_RECRUITING

Local Institution - 1452, Bucharest

NOT_YET_RECRUITING

Local Institution - 1453, Bucharest

NOT_YET_RECRUITING

Local Institution - 1454, Bucharest

NOT_YET_RECRUITING

Local Institution - 1455, Bucharest

NOT_YET_RECRUITING

Local Institution - 1456, Bucharest

NOT_YET_RECRUITING

Local Institution - 1458, Bucharest

010825

NOT_YET_RECRUITING

Local Institution - 1451, Bucharest

060222

NOT_YET_RECRUITING

Local Institution - 1459, Bucharest

03203

NOT_YET_RECRUITING

Local Institution - 1509, Elche (alicante)

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT07011732 - 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-1) | Biotech Hunter | Biotech Hunter