A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

600

Participants

Timeline

Start Date

November 21, 2025

Primary Completion Date

June 22, 2029

Study Completion Date

July 20, 2029

Conditions
Alzheimer DiseaseAgitation
Interventions
DRUG

KarXT

Specified dose on specified days

DRUG

KarX-EC

Specified dose on specified days

Trial Locations (207)

0

Local Institution - 2250, Győr

1036

Local Institution - 2255, Budapest

1058

Local Institution - 2005, Ciudad Autonoma de Buenos Aires

1088

Local Institution - 2251, Budapest

Local Institution - 2253, Budapest

1113

Local Institution - 1100, Sofia

1133

Local Institution - 2006, Buenos Aires

1199

Local Institution - 2004, Buenos Aires

1900

Local Institution - 1001, La Plata

3049

Local Institution - 1401, Coimbra

3200

Local Institution - 2254, Gyöngyös

4032

Local Institution - 2252, Debrecen

5000

Local Institution - 1004, Córdoba

Local Institution - 2000, Córdoba

Local Institution - 2002, Córdoba

5004

Local Institution - 1005, Córdoba

5006

Local Institution - 1000, Córdoba

5502

Local Institution - 2001, Mendoza

5800

Local Institution - 1101, Pleven

6300

Local Institution - 2257, Kalocsa

7200

Local Institution - 1103, Razgrad

8221

Local Institution - 1504, Terrassa

9020

Local Institution - 1102, Varna

10000

Local Institution - 1553, Zagreb

Local Institution - 1550, Zagreb

10200

Local Institution - 1361, Mexico City

10312

Local Institution - 2619, Staten Island

11527

Local Institution - 1202, Athens

Local Institution - 1203, Athens

14090

Local Institution - 1363, Mexico City

14269

Local Institution - 1360, Mexico City

15125

Local Institution - 1207, Athens

18600

Local Institution - 2106, Prague

20149

Local Institution - 2353, Milan

20877

Local Institution - 1636, Gaithersburg

22332

Local Institution - 2401, Incheon

25000

Local Institution - 1355, Saltillo

25123

Local Institution - 2356, Brescia

26504

Local Institution - 1200, Pátrai

26655

Local Institution - 2206, Westerstede

28006

Local Institution - 1508, Madrid

28040

Local Institution - 1505, Madrid

28112

Local Institution - 1601, Monroe

28557

Local Institution - 2608, Morehead City

29010

Local Institution - 0003, Málaga

Local Institution - 1502, Málaga

29205

Local Institution - 1653, Columbia

31000

Local Institution - 2150, Toulouse

31008

Local Institution - 1507, Pamplona

32127

Local Institution - 1612, Port Orange

32807

Local Institution - 1635, Orlando

33012

Local Institution - 2626, Hialeah

33135

Local Institution - 1618, Miami

33166

Local Institution - 1609, Miami

33186

Local Institution - 1604, Miami

33629

Local Institution - 2621, Tampa

37007

Local Institution - 1500, Salamanca

40221

Local Institution - 2201, Düsseldorf

41009

Local Institution - 1503, Seville

41404

Local Institution - 2400, Deagu

42000

Local Institution - 1552, Varaždin

44600

Local Institution - 1356, Guadajalara

45242

Local Institution - 2617, Blue Ash

45500

Local Institution - 1201, Ioannina

47012

Local Institution - 1506, Valladolid

48085

Local Institution - 1620, Troy

48105

Local Institution - 2618, Ann Arbor

48993

Local Institution - 1510, Getxo

49100

Local Institution - 2302, Petch Tikva

50012

Local Institution - 1501, Zaragoza

51000

Local Institution - 1554, Rijeka

54055

Local Institution - 1352, Tlalnepantla

54645

Local Institution - 1204, Thessaloniki

55130

Local Institution - 2256, Saint Paul

56126

Local Institution - 2350, Pisa

59037

Local Institution - 2153, Lille

64710

Local Institution - 1364, Monterrey

64711

Local Institution - 2203, Erbach im Odenwald

66460

Local Institution - 1350, Monterrey

67091

Local Institution - 2155, Strasbourg

69100

Local Institution - 2151, Villeurbanne

74136

Local Institution - 1640, Tulsa

75006

Local Institution - 2616, Carrollton

75010

Local Institution - 2152, Paris

75150

Local Institution - 2622, Mesquite

77065

Local Institution - 2605, Cypress

78216

Local Institution - 1362, San Luis Potosí City

78229

Local Institution - 2623, San Antonio

79912

Local Institution - 1643, El Paso

80131

Local Institution - 2351, Napoli

84010

Local Institution - 2612, Bountiful

85224

Local Institution - 2609, Chandler

85258

Local Institution - 1619, Scottsdale

86077

Local Institution - 2355, Isernia

87042

Local Institution - 2156, Limoges

89119

Local Institution - 1649, Las Vegas

90040

Local Institution - 2625, Long Beach

90123

Local Institution - 1461, Constanța

90805

Local Institution - 2607, Long Beach

91105

Local Institution - 2613, Pasadena

91120

Local Institution - 2301, Jerusalem

91303

Local Institution - 2620, Canoga Park

92037

Local Institution - 1637, La Jolla

92108

Local Institution - 2614, San Diego

94596

Local Institution - 1651, Walnut Creek

98122

Local Institution - 1644, Seattle

99201

Local Institution - 1654, Spokane

110029

Local Institution - 1253, New Delhi

221005

Local Institution - 1254, Varanasi

380060

Local Institution - 1255, Ahmedabad

500082

Local Institution - 1252, Hyderabad

507190

Local Institution - 1460, Sanpetru /Brasov

550082

Local Institution - 1462, Sibiu

700054

Local Institution - 1250, Kolkata

700282

Local Institution - 1457, Iași

1270244

Local Institution - 2053, Antofagasta

2511433

Local Institution - 2055, Viña del Mar

Local Institution - 2054, Vitacura

4244916

Local Institution - 2303, Netanya

5262000

Local Institution - 2305, Ramat Gan

5265601

Local Institution - 2300, Ramat Gan

7500710

Local Institution - 2051, Santiago

7590653

Local Institution - 2304, Rishon Le'Tzion

8330024

Local Institution - 2052, Santiago

70200730

Local Institution - 1051, Brasília

80810040

Local Institution - 1052, Curitiba

90560032

Local Institution - 1054, Porto Alegre

34134-4154

Local Institution - 2602, Bonita Springs

01608

Local Institution - 2615, Worcester

07764

Local Institution - 1647, West Long Branch

05201-9810

Local Institution - 1646, Bennington

B7602CBM

Local Institution - 1002, Mar del Plata

S2000

Local Institution - 1006, Rosario

C1428AQK

Local Institution - 1003, Buenos Aires

X5003DCE

Local Institution - 2003, Córdoba

80240-280

Local Institution - 1053, Curitiba

90430-001

Local Institution - 1058, Porto Alegre

13060-080

Local Institution - 1057, Campinas

04020-060

Local Institution - 1056, São Paulo

22270-060

Local Institution - 1050, Rio de Janeiro

01228-000

Local Institution - 1055, São Paulo

N6A 5A5

Local Institution - 1155, London

HR-21000

Local Institution - 1551, Split

779 00

Local Institution - 2107, Olomouc

160 00

Local Institution - 2100, Prague

628 00

Local Institution - 2103, Brno

565 01

Local Institution - 2101, Choceň

301 00

Local Institution - 2104, Pilsen

100 000

Local Institution - 2102, Prague

100 00

Local Institution - 2105, Prague

516 01

Local Institution - 2108, Rychnov nad Kněžnou

06120

Local Institution - 2205, Halle

115 26

Local Institution - 1205, Athens

106 79

Local Institution - 0027, Athens

Local Institution - 1206, Athens

500 034

Local Institution - 1251, Hyderabad

110 095

Local Institution - 1256, Delhi

00185

Local Institution - 2354, Rome

00189

Local Institution - 2352, Rome

00168

Local Institution - 2357, Roma

257-0003

Local Institution - 1301, Hadano

213-8507

Local Institution - 1307, Kawasaki

590-0018

Local Institution - 1304, Sakai

842-0192

Local Institution - 1303, Kanzaki-Gun Yoshinogari-Cho

847-0031

Local Institution - 1300, Karatsu-shi

113-8603

Local Institution - 1305, Bunkyo-ku

819-0037

Local Institution - 1302, Fukuoka

700-8557

Local Institution - 1306, Okayama

85-163

Local Institution - 2454, Bydgoszcz

41-500

Local Institution - 2456, Chorzów

40-146

Local Institution - 2455, Katowice

20-064

Local Institution - 2451, Lublin

Local Institution - 2452, Lublin

61-485

Local Institution - 2450, Poznan

96-500

Local Institution - 2453, Sochaczew

4835-044

Local Institution - 1402, Guimarães

1649-035

Local Institution - 1404, Lisbon

4464-513

Local Institution - 1403, Senhora da Hora

2560-280

Local Institution - 1400, Torres Vedras

041919

Local Institution - 1450, Bucharest

Local Institution - 1452, Bucharest

Local Institution - 1453, Bucharest

Local Institution - 1454, Bucharest

Local Institution - 1455, Bucharest

Local Institution - 1456, Bucharest

Local Institution - 1458, Bucharest

010825

Local Institution - 1451, Bucharest

060222

Local Institution - 1459, Bucharest

03080

Local Institution - 2407, Seoul

05030

Local Institution - 2403, Seoul

06351

Local Institution - 2406, Seoul

405-760

Local Institution - 2409, Incheon

05505

Local Institution - 2402, Seoul

06273

Local Institution - 2408, Seoul

07061

Local Institution - 2405, Seoul

07345

Local Institution - 2404, Seoul

03203

Local Institution - 1509, Elche (alicante)

PR2 9HT

Local Institution - 2505, Preston

KT16 9AU

Local Institution - 2508, Chertsey

CB21 5EF

Local Institution - 2502, Cambridge

SE5 8AZ

Local Institution - 2501, London

W12 0NN

Local Institution - 2500, London

ML1 4UF

Local Institution - 2510, Motherwell

TR15 3QE

Local Institution - 2507, Redruth

S5 7JT

Local Institution - 2504, Sheffield

ST16 3SR

Local Institution - 2509, Stafford

WV4 5HN

Local Institution - 2503, Wolverhampton

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY