A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
A Phase 3, Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-3)
3 other identifiers
interventional
600
26 countries
255
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 alzheimer-disease
Started Dec 2025
Typical duration for phase_3 alzheimer-disease
255 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedStudy Start
First participant enrolled
December 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 22, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 20, 2029
June 2, 2026
June 1, 2026
3.6 years
April 15, 2025
June 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Up to approximately Week 30
Secondary Outcomes (17)
Number of Participants With Adverse Events (AEs)
Up to approximately Week 30
Number of Participants With Serious AEs (SAEs)
Up to approximately Week 30
Number of Participants With TEAEs Leading to Study Withdrawal
Up to approximately Week 30
Number of Participants With TEAEs Leading to Death
Up to approximately Week 30
Number of Participants with Adverse Events of Special Interest (AESI)
Up to approximately Week 30
- +12 more secondary outcomes
Study Arms (1)
KarXT+KarX-EC
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Participants must have completed study CN012-0023 or CN012-0024 per protocol.
- Participants must have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more).
You may not qualify if:
- Participants must not have clinically significant cardiovascular (eg, untreated or unstable hypertension, clinically significant tachycardia), pulmonary, renal, hematologic, GI, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (255)
Local Institution - 2609
Chandler, Arizona, 85224, United States
Imaging Endpoints
Scottsdale, Arizona, 85258, United States
Local Institution - 1657
Anaheim, California, 92805, United States
Local Institution - 2620
Canoga Park, California, 91303, United States
Local Institution - 1637
La Jolla, California, 92037, United States
Local Institution - 2625
Long Beach, California, 90040, United States
Local Institution - 2607
Long Beach, California, 90805, United States
Local Institution - 2642
Long Beach, California, 90807, United States
Local Institution - 2613
Pasadena, California, 91105, United States
Local Institution - 1662
Pomona, California, 91767, United States
Local Institution - 1639
Torrance, California, 90505, United States
Local Institution - 1651
Walnut Creek, California, 94596, United States
Local Institution - 2602
Bonita Springs, Florida, 34134-4154, United States
Local Institution - 2626
Hialeah, Florida, 33012, United States
Local Institution - 1602
Miami, Florida, 33122, United States
Local Institution - 1618
Miami, Florida, 33135, United States
Nuovida Research Center
Miami, Florida, 33186, United States
Local Institution - 1635
Orlando, Florida, 32807, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
IPTB Clinical Research
Tampa, Florida, 33629, United States
Hope Research Network - Miami
Virginia Gardens, Florida, 33166, United States
Local Institution - 2611
Atlanta, Georgia, 30328, United States
Local Institution - 1636
Gaithersburg, Maryland, 20877, United States
Boston Center for Memory
Newton, Massachusetts, 02459, United States
Local Institution - 2615
Worcester, Massachusetts, 01608, United States
Local Institution - 2618
Ann Arbor, Michigan, 48105, United States
Local Institution - 1620
Troy, Michigan, 48085, United States
Local Institution - 2256
Saint Paul, Minnesota, 55130, United States
Local Institution - 2629
Hattiesburg, Mississippi, 39402, United States
Local Institution - 2628
Las Vegas, Nevada, 89030, United States
Redbird Research
Las Vegas, Nevada, 89119, United States
Local Institution - 1647
West Long Branch, New Jersey, 07764, United States
Local Institution - 1656
New Windsor, New York, 12553, United States
Local Institution - 2619
Staten Island, New York, 10312, United States
Local Institution - 1658
Woodmere, New York, 11598-1739, United States
West Clinical Research
Morehead City, North Carolina, 28557, United States
Local Institution - 2617
Blue Ash, Ohio, 45242, United States
Local Institution - 1640
Tulsa, Oklahoma, 74136, United States
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, 75006, United States
Local Institution - 2605
Cypress, Texas, 77065, United States
Local Institution - 1643
El Paso, Texas, 79912, United States
Local Institution - 2622
Mesquite, Texas, 75150, United States
Local Institution - 2623
San Antonio, Texas, 78229, United States
Pantheon Clinical Research, LLC
Bountiful, Utah, 84010, United States
Local Institution - 1646
Bennington, Vermont, 05201-9810, United States
Local Institution - 1644
Seattle, Washington, 98122, United States
Local Institution - 1654
Spokane, Washington, 99201, United States
Local Institution - 2610
Milwaukee, Wisconsin, 53226, United States
Local Institution - 2005
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1058, Argentina
Local Institution - 1001
La Plata, Buenos Aires, 1900, Argentina
Local Institution - 1002
Mar del Plata, Buenos Aires, B7602CBM, Argentina
Local Institution - 2006
Buenos Aires, Buenos Aires F.D., 1133, Argentina
Local Institution - 1006
Rosario, Santa Fe Province, S2000, Argentina
Local Institution - 2004
Buenos Aires, 1199, Argentina
Local Institution - 1003
Buenos Aires, C1428AQK, Argentina
Local Institution - 1004
Córdoba, 5000, Argentina
Local Institution - 2000
Córdoba, 5000, Argentina
Local Institution - 2002
Córdoba, 5000, Argentina
Local Institution - 1005
Córdoba, 5004, Argentina
Local Institution - 1000
Córdoba, 5006, Argentina
Local Institution - 2003
Córdoba, X5003DCE, Argentina
Local Institution - 2001
Mendoza, 5502, Argentina
Local Institution - 1051
Brasília, Federal District, 70200730, Brazil
Local Institution - 1052
Curitiba, Paraná, 80230-130, Brazil
Local Institution - 1053
Curitiba, Paraná, 80240-280, Brazil
Local Institution - 1058
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Local Institution - 1054
Porto Alegre, Rio Grande do Sul, 90560-032, Brazil
Local Institution - 1057
Campinas, São Paulo, 13060-080, Brazil
Local Institution - 1050
Rio de Janeiro, 22270-060, Brazil
Local Institution - 1055
São Paulo, 01228-000, Brazil
Local Institution - 1056
São Paulo, 04020-060, Brazil
Local Institution - 1100
Sofia, Sofia-Grad, 1113, Bulgaria
Local Institution - 1104
Sofia, Sofia-Grad, 1202, Bulgaria
Local Institution - 1101
Pleven, 5800, Bulgaria
Local Institution - 1103
Razgrad, 7200, Bulgaria
Local Institution - 1102
Varna, 9020, Bulgaria
Local Institution - 1153
Hamilton, Ontario, ON L8M 1W9, Canada
Local Institution - 1155
London, Ontario, N6A 5A5, Canada
Local Institution - 1151
Toronto, Ontario, M4N 3M5, Canada
Local Institution - 1154
Toronto, Ontario, M6J 1H4, Canada
Local Institution - 1152
Whitby, Ontario, L1N 5S9, Canada
Local Institution - 2051
Santiago, Santiago Metropolitan, 7500710, Chile
Local Institution - 2052
Santiago, Santiago Metropolitan, 8330024, Chile
Local Institution - 2054
Vitacura, Santiago Metropolitan, 2511433, Chile
Local Institution - 2055
Viña del Mar, Valparaiso, 2511433, Chile
Local Institution - 2053
Antofagasta, 1270244, Chile
Local Institution - 1805
Beijing, Beijing Municipality, 100053, China
Local Institution - 1810
Beijing, Beijing Municipality, 100088, China
Local Institution - 1815
Haidian District, Beijing Municipality, 100191, China
Local Institution - 1809
Guangzhou, Guangdong, 0, China
Local Institution - 1818
Shenzhen, Guangdong, 518118, China
Local Institution - 1802
Guangzhou, Guangzhou Province, 510260, China
Local Institution - 1803
Changsha, Hunan, 410008, China
Local Institution - 1801
Nanjing, Jiangsu, 210008, China
Local Institution - 1814
Tianjin, Tianjin Municipality, 300074, China
Local Institution - 1804
Hangzhou, Zhejiang, 310003, China
Local Institution - 1817
Hangzhou, Zhejiang, 310016, China
Local Institution - 1812
Kunming, 650032, China
Local Institution - 1553
Zagreb, City of Zagreb, 10000, Croatia
Local Institution - 1554
Rijeka, 51000, Croatia
Local Institution - 1551
Split, HR-21000, Croatia
Local Institution - 1552
Varaždin, 42000, Croatia
Local Institution - 1550
Zagreb, 10000, Croatia
Local Institution - 2107
Olomouc, Olomouc Region, 779 00, Czechia
Local Institution - 2100
Prague, Praha 6, 160 00, Czechia
Local Institution - 2106
Prague, Praha 8, 18600, Czechia
Local Institution - 2103
Brno, South Moravian, 628 00, Czechia
Local Institution - 2101
Choceň, 565 01, Czechia
Local Institution - 2104
Pilsen, 301 00, Czechia
Local Institution - 2102
Prague, 100 000, Czechia
Local Institution - 2105
Prague, 100 00, Czechia
Local Institution - 2108
Rychnov nad Kněžnou, 516 01, Czechia
Local Institution - 2150
Toulouse, Haute-Garonne, 31000, France
Local Institution - 2151
Villeurbanne, Rhône, 69100, France
Local Institution - 2153
Lille, 59037, France
Local Institution - 2156
Limoges, 87042, France
Local Institution - 2157
Montpellier, 34295, France
Local Institution - 2152
Paris, 75010, France
Local Institution - 2155
Strasbourg, 67091, France
Local Institution - 2201
Düsseldorf, 40221, Germany
Local Institution - 2205
Halle, 06120, Germany
Local Institution - 2206
Westerstede, 26655, Germany
Local Institution - 1200
Pátrai, Achaḯa, 26504, Greece
Local Institution - 1205
Athens, Attica, 115 26, Greece
Local Institution - 1202
Athens, Attica, 11527, Greece
Local Institution - 1203
Chaïdári, Attikí, 124 62, Greece
Local Institution - 0027
Athens, 106 79, Greece
Local Institution - 1206
Athens, 106 79, Greece
Local Institution - 1207
Athens, 15125, Greece
Local Institution - 1201
Ioannina, 45500, Greece
Local Institution - 1204
Thessaloniki, 54645, Greece
Local Institution - 2257
Kalocsa, Bács-Kiskun county, 6300, Hungary
Local Institution - 2250
Győr, Győr-Moson-Sopron, 0, Hungary
Local Institution - 2254
Gyöngyös, Heves County, 3200, Hungary
Local Institution - 2255
Budapest, 1036, Hungary
Local Institution - 2251
Budapest, 1088, Hungary
Local Institution - 2253
Budapest, 1088, Hungary
Local Institution - 2252
Debrecen, 4032, Hungary
Local Institution - 1255
Ahmedabad, Gujarat, 380060, India
Local Institution - 1252
Hyderabad, Telangana, 500082, India
Local Institution - 1254
Varanasi, Uttar Pradesh, 221005, India
Local Institution - 1250
Kolkata, West Bengal, 700054, India
Local Institution - 1256
Delhi, 110 095, India
Local Institution - 1251
Hyderabad, 500034, India
Local Institution - 1253
New Delhi, 110029, India
Local Institution - 2302
Petch Tikva, IL, 49100, Israel
Local Institution - 2303
Netanya, 4244916, Israel
Local Institution - 2305
Ramat Gan, 5262000, Israel
Local Institution - 2300
Ramat Gan, 5265601, Israel
Local Institution - 2304
Rishon Le'Tzion, 7590653, Israel
Local Institution - 2351
Naples, Campania, 80131, Italy
Local Institution - 2354
Rome, Lazio, 00185, Italy
Local Institution - 2352
Rome, Lazio, 00189, Italy
Local Institution - 2353
Milan, Lombardy, 20149, Italy
Local Institution - 2350
Pisa, PI, 56126, Italy
Local Institution - 2356
Brescia, 25123, Italy
Local Institution - 2355
Isernia, 86077, Italy
Local Institution - 2357
Roma, 00168, Italy
Hatano Kousei Hospital
Hadano, Kanagawa, 257-0003, Japan
Local Institution - 1307
Kawasaki, Kanagawa, 213-8507, Japan
Asakayama Hospital
Sakai, Osaka, 590-0018, Japan
National Hospital Organization Hizen Psychiatric Center
Kanzaki-Gun Yoshinogari-Cho, Saga-ken, 842-0192, Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, 847-0031, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603, Japan
Kuramitsu Hospital
Fukuoka, 819-0037, Japan
Okayama City General Medical Center Okayama City Hospital
Okayama, 700-8557, Japan
Local Institution - 1308
Shimotsuke-shi, Tochigi, 329-0498, Japan
Local Institution - 1355
Saltillo, Coahuila, 25000, Mexico
Local Institution - 1356
Guadalajara, Jalisco, 44600, Mexico
Local Institution - 1363
Mexico City, Mexico City, 14090, Mexico
Local Institution - 1360
Mexico City, Mexico City, 14269, Mexico
Local Institution - 1364
Monterrey, Nuevo León, 64623, Mexico
Local Institution - 1350
Monterrey, Nuevo León, 66460, Mexico
Local Institution - 1361
Mexico City, 10200, Mexico
Local Institution - 1362
San Luis Potosí City, 78216, Mexico
Local Institution - 1352
Tlalnepantla, 54055, Mexico
Local Institution - 2450
Poznan, Greater Poland Voivodeship, 61-485, Poland
Local Institution - 2454
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland
Local Institution - 2456
Chorzów, 41-500, Poland
Local Institution - 2455
Katowice, 40-146, Poland
Local Institution - 2451
Lublin, 20-064, Poland
Local Institution - 2452
Lublin, 20-064, Poland
Local Institution - 2453
Sochaczew, 96-500, Poland
Local Institution - 2457
Wroclaw, 53-659, Poland
Local Institution - 1401
Coimbra, 3049, Portugal
Local Institution - 1402
Guimarães, 4835-044, Portugal
Local Institution - 1404
Lisbon, 1649-035, Portugal
Local Institution - 1403
Senhora da Hora, 4464-513, Portugal
Local Institution - 1400
Torres Vedras, 2560-280, Portugal
Local Institution - 1450
Bucharest, Bucharest, 041919, Romania
Local Institution - 1452
Bucharest, Bucharest, 041919, Romania
Local Institution - 1453
Bucharest, Bucharest, 041919, Romania
Local Institution - 1454
Bucharest, Bucharest, 041919, Romania
Local Institution - 1455
Bucharest, Bucharest, 041919, Romania
Local Institution - 1456
Bucharest, Bucharest, 041919, Romania
Local Institution - 1458
Bucharest, Bucharest, 041919, Romania
Local Institution - 1451
Bucharest, 010825, Romania
Local Institution - 1459
Bucharest, 060222, Romania
Local Institution - 1461
Constanța, 90123, Romania
Local Institution - 1457
Iași, 700282, Romania
Local Institution - 1460
Sanpetru /Brasov, 507190, Romania
Local Institution - 1462
Sibiu, 550082, Romania
Local Institution - 2401
Incheon, Incheon Gwang'yeogsi, 22332, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea
Local Institution - 2403
Seoul, Seoul-teukbyeolsi [Seoul], 05030, South Korea
Local Institution - 2406
Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea
Local Institution - 2400
Deagu, Taegu-Kwangyǒkshi, 41404, South Korea
Local Institution - 2409
Incheon, 405-760, South Korea
Local Institution - 2402
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Local Institution - 2405
Seoul, 07061, South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345, South Korea
Local Institution - 1510
Getxo, Bizkaia, 48993, Spain
Local Institution - 1509
Elche (alicante), 03203, Spain
Local Institution - 1508
Madrid, 28006, Spain
Local Institution - 1505
Madrid, 28040, Spain
Local Institution - 0003
Málaga, 29010, Spain
Local Institution - 1502
Málaga, 29010, Spain
Local Institution - 1507
Pamplona, 31008, Spain
Local Institution - 1500
Salamanca, 37007, Spain
Local Institution - 1503
Seville, 41009, Spain
Local Institution - 1504
Terrassa, 8221, Spain
Local Institution - 1506
Valladolid, 47012, Spain
Local Institution - 1501
Zaragoza, 50012, Spain
Local Institution - 1753
Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan
Local Institution - 1751
Tainan, Taiana, 704, Taiwan
Local Institution - 1754
Taipei, 100229, Taiwan
Local Institution - 1750
Taipei, 112, Taiwan
Local Institution - 1752
Taoyuan, 333, Taiwan
Local Institution - 2555
Smila, Cherkasy Oblast, 20708, Ukraine
Local Institution - 2554
Dnipro, Dnipropetrovsk Oblast, 49115, Ukraine
Local Institution - 2559
Skarzhyntsi, Khmelnytskyi Oblast, 32120, Ukraine
Local Institution - 2566
Hlevakha, Kyiv Oblast, 08631, Ukraine
Local Institution - 2552
Lviv, Lviv Oblast, 79035, Ukraine
Local Institution - 2558
Lviv, Lviv Oblast, 79035, Ukraine
Local Institution - 2569
Lviv, Lviv Oblast, 79035, Ukraine
Local Institution - 2567
Oleksandrivka, Odesa Oblast, 67513, Ukraine
Local Institution - 2562
Ternopil, Ternopil Oblast, 460027, Ukraine
Local Institution - 2551
Vinnytsia, Vinnytsia Oblast, 21037, Ukraine
Local Institution - 2556
Hlevakha, 08631, Ukraine
Local Institution - 2550
Kropyvnytskyi, 25491, Ukraine
Local Institution - 2565
Kyiv, 01030, Ukraine
Local Institution - 2553
Kyiv, 04080, Ukraine
Local Institution - 2568
Odesa, 65006, Ukraine
Local Institution - 2557
Poltava, 36013, Ukraine
Local Institution - 2505
Preston, Lancashire, PR2 9HT, United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, Surrey, KT16 9AU, United Kingdom
Local Institution - 2502
Cambridge, CB21 5EF, United Kingdom
Local Institution - 2501
London, SE5 8AZ, United Kingdom
Local Institution - 2500
London, W12 0NN, United Kingdom
NeuroClin Glasgow
Motherwell, ML1 4UF, United Kingdom
Cornwall Partnership NHS Foundation Trust
Redruth, TR15 3QE, United Kingdom
Local Institution - 2504
Sheffield, S5 7JT, United Kingdom
Local Institution - 2509
Stafford, ST16 3SR, United Kingdom
Local Institution - 2503
Wolverhampton, WV4 5HN, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Central Study Contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com
CONTACT
First line of the email MUST contain NCT # and Site #.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2025
First Posted
April 22, 2025
Study Start
December 2, 2025
Primary Completion (Estimated)
June 22, 2029
Study Completion (Estimated)
July 20, 2029
Last Updated
June 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See Plan Description
- Access Criteria
- See Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html