Clinical trial · NCT06937229

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

RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

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.

Interventions

KarXT · DRUG
Specified dose on specified days
KarX-EC · DRUG
Specified dose on specified days

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Participants must have completed study CN012-0023 or CN012-0024 per protocol.
* Participants must have an identified caregiver who has sufficient contact (approximately 8 hours over a week).

Exclusion Criteria:

* 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Sites (252)

Local Institution - 2609, Chandler, Arizona · Not yet recruiting
Imaging Endpoints, Scottsdale, Arizona · Recruiting
Local Institution - 1657, Anaheim, California · Not yet recruiting
Local Institution - 1668, Fresno, California · Not yet recruiting
Local Institution - 2625, Long Beach, California · Not yet recruiting
Local Institution - 2642, Long Beach, California · Not yet recruiting
Local Institution - 2649, Orange, California · Not yet recruiting
Local Institution - 2613, Pasadena, California · Not yet recruiting
Local Institution - 1662, Pomona, California · Not yet recruiting
Local Institution - 1639, Torrance, California · Not yet recruiting
Local Institution - 1651, Walnut Creek, California · Not yet recruiting
Local Institution - 2602, Bonita Springs, Florida · Not yet recruiting
Nuovida Research Center, Miami, Florida · Recruiting
Local Institution - 1635, Orlando, Florida · Not yet recruiting
Progressive Medical Research, Port Orange, Florida · Recruiting
IPTB Clinical Research, Tampa, Florida · Recruiting
Hope Research Network - Miami, Virginia Gardens, Florida · Recruiting
Local Institution - 2611, Atlanta, Georgia · Not yet recruiting
Local Institution - 1636, Gaithersburg, Maryland · Not yet recruiting
Boston Center for Memory, Newton, Massachusetts · Recruiting
Local Institution - 2615, Worcester, Massachusetts · Not yet recruiting
Local Institution - 1620, Troy, Michigan · Not yet recruiting
Local Institution - 2256, Saint Paul, Minnesota · Not yet recruiting
Local Institution - 2629, Hattiesburg, Mississippi · Not yet recruiting
Local Institution - 2628, Las Vegas, Nevada · Not yet recruiting
Redbird Research, Las Vegas, Nevada · Recruiting
Local Institution - 1664, Princeton, New Jersey · Not yet recruiting
Local Institution - 1656, New Windsor, New York · Not yet recruiting
Local Institution - 2619, Staten Island, New York · Not yet recruiting
Local Institution - 1658, Woodmere, New York · Not yet recruiting
West Clinical Research, Morehead City, North Carolina · Recruiting
Local Institution - 2617, Blue Ash, Ohio · Not yet recruiting
Local Institution - 1640, Tulsa, Oklahoma · Not yet recruiting
Epic Medical Research, LLC - Carrolton, Carrollton, Texas · Recruiting
Local Institution - 2605, Cypress, Texas · Not yet recruiting
Local Institution - 1643, El Paso, Texas · Not yet recruiting
Local Institution - 2622, Mesquite, Texas · Not yet recruiting
Local Institution - 2623, San Antonio, Texas · Not yet recruiting
Local Institution - 2612, Bountiful, Utah · Completed
Local Institution - 1646, Bennington, Vermont · Not yet recruiting
Local Institution - 1644, Seattle, Washington · Not yet recruiting
Local Institution - 2610, Milwaukee, Wisconsin · Not yet recruiting
Local Institution - 2005, Ciudad Autonoma de Buenos Aires, Buenos Aires · Not yet recruiting
Local Institution - 1001, La Plata, Buenos Aires · Not yet recruiting
Local Institution - 1002, Mar del Plata, Buenos Aires · Not yet recruiting
Local Institution - 2006, Buenos Aires, Buenos Aires F.D. · Not yet recruiting
Local Institution - 1006, Rosario, Santa Fe Province · Not yet recruiting
Local Institution - 2004, Buenos Aires, Argentina · Not yet recruiting
Local Institution - 1003, Buenos Aires, Argentina · Not yet recruiting
Local Institution - 1004, Córdoba, Argentina · Not yet recruiting
Local Institution - 2000, Córdoba, Argentina · Not yet recruiting
Local Institution - 2002, Córdoba, Argentina · Not yet recruiting
Local Institution - 1005, Córdoba, Argentina · Not yet recruiting
Local Institution - 1000, Córdoba, Argentina · Not yet recruiting
Local Institution - 2003, Córdoba, Argentina · Not yet recruiting
Local Institution - 2001, Mendoza, Argentina · Not yet recruiting
Local Institution - 1051, Brasília, Federal District · Not yet recruiting
Local Institution - 1052, Curitiba, Paraná · Not yet recruiting
Local Institution - 1053, Curitiba, Paraná · Not yet recruiting
Local Institution - 1058, Porto Alegre, Rio Grande do Sul · Not yet recruiting
Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul · Recruiting
Local Institution - 1057, Campinas, São Paulo · Not yet recruiting
Local Institution - 1050, Rio de Janeiro, Brazil · Not yet recruiting
CPQuali Pesquisa Clínica, São Paulo, Brazil · Recruiting
Local Institution - 1056, São Paulo, Brazil · Not yet recruiting
Local Institution - 1101, Pleven, Bulgaria · Not yet recruiting
Local Institution - 1103, Razgrad, Bulgaria · Not yet recruiting
Medical Center Sveti Naum EOOD, Sofia, Bulgaria · Recruiting
Local Institution - 1104, Sofia, Bulgaria · Not yet recruiting
Local Institution - 1102, Varna, Bulgaria · Not yet recruiting
Local Institution - 1153, Hamilton, Ontario · Not yet recruiting
Local Institution - 1155, London, Ontario · Not yet recruiting
Local Institution - 1151, Toronto, Ontario · Not yet recruiting
Local Institution - 1154, Toronto, Ontario · Not yet recruiting
Ontario Shores Centre For Mental Health Sciences, Whitby, Ontario · Recruiting
Local Institution - 2051, Santiago, Santiago Metropolitan · Not yet recruiting
Local Institution - 2052, Santiago, Santiago Metropolitan · Not yet recruiting
Local Institution - 2054, Vitacura, Santiago Metropolitan · Not yet recruiting
Local Institution - 2055, Viña del Mar, Valparaiso · Not yet recruiting
Local Institution - 2053, Antofagasta, Chile · Not yet recruiting
Local Institution - 1805, Beijing, Beijing Municipality · Not yet recruiting
Local Institution - 1810, Beijing, Beijing Municipality · Not yet recruiting
Local Institution - 1815, Haidian District, Beijing Municipality · Not yet recruiting
Local Institution - 1809, Guangzhou, Guangdong · Not yet recruiting
Local Institution - 1818, Shenzhen, Guangdong · Not yet recruiting
Local Institution - 1802, Guangzhou, Guangzhou Province · Not yet recruiting
Local Institution - 1803, Changsha, Hunan · Not yet recruiting
Local Institution - 1801, Nanjing, Jiangsu · Not yet recruiting
Local Institution - 1814, Tianjin, Tianjin Municipality · Not yet recruiting
Local Institution - 1804, Hangzhou, Zhejiang · Not yet recruiting
Local Institution - 1817, Hangzhou, Zhejiang · Not yet recruiting
Local Institution - 1812, Kunming, China · Not yet recruiting
Local Institution - 1553, Zagreb, City of Zagreb · Not yet recruiting
Local Institution - 1554, Rijeka, Croatia · Not yet recruiting
Local Institution - 1551, Split, Croatia · Not yet recruiting
Local Institution - 1552, Varaždin, Croatia · Not yet recruiting
Local Institution - 1555, Zagreb, Croatia · Not yet recruiting
Local Institution - 1550, Zagreb, Croatia · Not yet recruiting
Local Institution - 2107, Olomouc, Olomouc Region · Not yet recruiting
Local Institution - 2100, Prague, Praha 6 · Not yet recruiting
Local Institution - 2106, Prague, Praha 8 · Not yet recruiting
Neuro Health Centrum s.r.o., Brno, South Moravian · Recruiting
Local Institution - 2101, Choceň, Czechia · Not yet recruiting
Local Institution - 2104, Pilsen, Czechia · Not yet recruiting
Local Institution - 2102, Prague, Czechia · Withdrawn
Local Institution - 2105, Prague, Czechia · Withdrawn
Local Institution - 2108, Rychnov nad Kněžnou, Czechia · Not yet recruiting
Centre Hospitalier Universitaire Toulouse - Cité de la Santé, Toulouse, Haute-Garonne · Recruiting
Local Institution - 2151, Villeurbanne, Rhône · Not yet recruiting
Local Institution - 2153, Lille, France · Not yet recruiting
Local Institution - 2156, Limoges, France · Not yet recruiting
Local Institution - 2157, Montpellier, France · Not yet recruiting
Local Institution - 2152, Paris, France · Not yet recruiting
Local Institution - 2155, Strasbourg, France · Not yet recruiting
Local Institution - 2201, Düsseldorf, Germany · Not yet recruiting
Local Institution - 2205, Halle, Germany · Not yet recruiting
Local Institution - 2206, Westerstede, Germany · Not yet recruiting
Local Institution - 1200, Pátrai, Achaḯa · Not yet recruiting
Local Institution - 1205, Athens, Attica · Not yet recruiting
Local Institution - 1202, Athens, Attica · Not yet recruiting
Local Institution - 1203, Chaïdári, Attikí · Not yet recruiting
Local Institution - 0027, Athens, Greece · Withdrawn
Local Institution - 1206, Athens, Greece · Not yet recruiting
Local Institution - 1207, Athens, Greece · Not yet recruiting
Local Institution - 1201, Ioannina, Greece · Not yet recruiting
Local Institution - 1204, Thessaloniki, Greece · Not yet recruiting
Local Institution - 2257, Kalocsa, Bács-Kiskun county · Not yet recruiting
Local Institution - 2250, Győr, Győr-Moson-Sopron · Withdrawn
Local Institution - 2255, Budapest, Hungary · Not yet recruiting
Local Institution - 2251, Budapest, Hungary · Withdrawn
Local Institution - 2253, Budapest, Hungary · Not yet recruiting
Local Institution - 2252, Debrecen, Hungary · Not yet recruiting
Local Institution - 2254, Gyöngyös, Hungary · Withdrawn
Local Institution - 1255, Ahmedabad, Gujarat · Not yet recruiting
Local Institution - 1252, Hyderabad, Telangana · Not yet recruiting
Local Institution - 1254, Varanasi, Uttar Pradesh · Not yet recruiting
Local Institution - 1250, Kolkata, West Bengal · Not yet recruiting
Local Institution - 1256, Delhi, India · Not yet recruiting
Local Institution - 1251, Hyderabad, India · Not yet recruiting
Local Institution - 1253, New Delhi, India · Not yet recruiting
Local Institution - 2302, Petch Tikva, IL · Not yet recruiting
Sanz MC, Laniado Hospital, Netanya, Israel · Recruiting
Local Institution - 2305, Ramat Gan, Israel · Not yet recruiting
Local Institution - 2300, Ramat Gan, Israel · Not yet recruiting
Bayit Balev Ltd., Rishon Le'Tzion, Israel · Recruiting
Local Institution - 2351, Naples, Campania · Not yet recruiting
Local Institution - 2354, Rome, Lazio · Not yet recruiting
Local Institution - 2352, Rome, Lazio · Not yet recruiting
Auxologico IRCCS - Auxologico San Luca, Milan, Lombardy · Recruiting
Local Institution - 2350, Pisa, PI · Not yet recruiting
Local Institution - 2356, Brescia, Italy · Not yet recruiting
Local Institution - 2355, Isernia, Italy · Withdrawn
Local Institution - 2357, Roma, Italy · Not yet recruiting
Hatano Kousei Hospital, Hadano, Kanagawa · Recruiting
Local Institution - 1307, Kawasaki, Kanagawa · Not yet recruiting
Asakayama Hospital, Sakai, Osaka · Recruiting
National Hospital Organization Hizen Psychiatric Center, Kanzaki-Gun Yoshinogari-Cho, Saga-ken · Recruiting
Rainbow and Sea Hospital, Karatsu-shi, Saga-ken · Recruiting
Nippon Medical School Hospital, Bunkyo-ku, Tokyo · Recruiting
Kuramitsu Hospital, Fukuoka, Japan · Recruiting
Okayama City General Medical Center Okayama City Hospital, Okayama, Japan · Recruiting
Local Institution - 1308, Shimotsuke-shi, Tochigi, Japan · Not yet recruiting
Local Institution - 1355, Saltillo, Coahuila · Not yet recruiting
Local Institution - 1356, Guadalajara, Jalisco · Not yet recruiting
Local Institution - 1363, Mexico City, Mexico City · Not yet recruiting
Local Institution - 1360, Mexico City, Mexico City · Not yet recruiting
AVIX Investigacion Clinica, Monterrey, Nuevo León · Recruiting
Local Institution - 1350, Monterrey, Nuevo León · Not yet recruiting
Local Institution - 1361, Mexico City, Mexico · Not yet recruiting
Neurociencias PRISMA A.C., San Luis Potosí City, Mexico · Recruiting
Local Institution - 1352, Tlalnepantla, Mexico · Not yet recruiting
Local Institution - 2450, Poznan, Greater Poland Voivodeship · Not yet recruiting
Local Institution - 2454, Bydgoszcz, Kuyavian-Pomeranian Voivodeship · Not yet recruiting
Local Institution - 2456, Chorzów, Poland · Not yet recruiting
Local Institution - 2455, Katowice, Poland · Withdrawn
Local Institution - 2458, Krakow, Poland · Not yet recruiting
Local Institution - 2451, Lublin, Poland · Withdrawn
Local Institution - 2452, Lublin, Poland · Withdrawn
RCMed Oddzial Sochaczew, Sochaczew, Poland · Recruiting
Local Institution - 2457, Wroclaw, Poland · Not yet recruiting
Local Institution - 1401, Coimbra, Portugal · Not yet recruiting
Local Institution - 1402, Guimarães, Portugal · Not yet recruiting
Local Institution - 1404, Lisbon, Portugal · Not yet recruiting
Local Institution - 1403, Senhora da Hora, Portugal · Not yet recruiting
Local Institution - 1400, Torres Vedras, Portugal · Not yet recruiting
Local Institution - 1450, Bucharest, Bucharest · Not yet recruiting
Local Institution - 1452, Bucharest, Bucharest · Not yet recruiting
Local Institution - 1453, Bucharest, Bucharest · Not yet recruiting
Local Institution - 1454, Bucharest, Bucharest · Not yet recruiting
Local Institution - 1455, Bucharest, Bucharest · Not yet recruiting
Local Institution - 1456, Bucharest, Bucharest · Not yet recruiting
Local Institution - 1458, Bucharest, Bucharest · Not yet recruiting
Local Institution - 1451, Bucharest, Romania · Withdrawn
Local Institution - 1463, Bucharest, Romania · Not yet recruiting
Local Institution - 1459, Bucharest, Romania · Withdrawn
Local Institution - 1461, Constanța, Romania · Not yet recruiting
Local Institution - 1457, Iași, Romania · Not yet recruiting
Local Institution - 1460, Sanpetru /Brasov, Romania · Not yet recruiting
Local Institution - 1464, Sibiu, Romania · Not yet recruiting
Local Institution - 1462, Sibiu, Romania · Not yet recruiting
Inha University Hospital, Incheon, Incheon Gwang'yeogsi · Recruiting
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [Seoul] · Recruiting
Local Institution - 2403, Seoul, Seoul-teukbyeolsi [Seoul] · Not yet recruiting
Local Institution - 2406, Seoul, Seoul-teukbyeolsi [Seoul] · Withdrawn
Local Institution - 2400, Deagu, Taegu-Kwangyǒkshi · Not yet recruiting
Local Institution - 2409, Incheon, South Korea · Not yet recruiting
Local Institution - 2402, Seoul, South Korea · Not yet recruiting
Gangnam Severance Hospital, Yonsei University Health System, Seoul, South Korea · Recruiting
Local Institution - 2405, Seoul, South Korea · Not yet recruiting
The Catholic University of Korea, Yeouido St.Mary's Hospital, Seoul, South Korea · Recruiting
Oroitu CAE, Getxo, Bizkaia · Recruiting
Local Institution - 1509, Elche (alicante), Spain · Not yet recruiting
Local Institution - 1508, Madrid, Spain · Not yet recruiting
Hospital Clinico San Carlos, Madrid, Spain · Recruiting
Hospital Clinico Universitario Virgen de La Victoria, Málaga, Spain · Recruiting
Local Institution - 0003, Málaga, Spain · Withdrawn
Local Institution - 1507, Pamplona, Spain · Not yet recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca, Salamanca, Spain · Recruiting
Local Institution - 1503, Seville, Spain · Not yet recruiting
Hospital Mutua Terrassa, Terrassa, Spain · Recruiting
Hospital Universitario De Rio Hortega, Valladolid, Spain · Recruiting
Local Institution - 1501, Zaragoza, Spain · Not yet recruiting
Local Institution - 1753, Kaohsiung Niao Sung Dist, Kaohsiung · Not yet recruiting
Local Institution - 1751, Tainan, Taiana, Taiwan · Not yet recruiting
Local Institution - 1754, Taipei, Taiwan · Not yet recruiting
Taipei Veterans General Hospital, Taipei, Taiwan · Recruiting
Local Institution - 1752, Taoyuan, Taiwan · Not yet recruiting
Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council", Smila, Cherkasy Oblast · Recruiting
MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC, Dnipro, Dnipropetrovsk Oblast · Recruiting
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council, Skarzhyntsi, Khmelnytskyi Oblast · Recruiting
Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association", Hlevakha, Kyiv Oblast · Recruiting
COMMUNAL NONCOMMERCIAL ENTERPRISE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital", Lviv, Lviv Oblast · Recruiting
Local Institution - 2558, Lviv, Lviv Oblast · Not yet recruiting
Local Institution - 2569, Lviv, Lviv Oblast · Not yet recruiting
Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council, Oleksandrivka, Odesa Oblast · Recruiting
Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC", Vinnytsia, Vinnytsia Oblast · Recruiting
Local Institution - 2556, Hlevakha, Ukraine · Not yet recruiting
Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council, Kropyvnytskyi, Ukraine · Recruiting
Local Institution - 2565, Kyiv, Ukraine · Not yet recruiting
Local Institution - 2553, Kyiv, Ukraine · Not yet recruiting
Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council", Poltava, Ukraine · Recruiting
Local Institution - 2562, Ternopil, Ukraine · Not yet recruiting
Local Institution - 2505, Preston, Lancashire · Not yet recruiting
Surrey and Borders Partnership NHS Foundation Trust, Chertsey, Surrey · Recruiting
Local Institution - 2502, Cambridge, United Kingdom · Not yet recruiting
Local Institution - 2501, London, United Kingdom · Not yet recruiting
Local Institution - 2500, London, United Kingdom · Not yet recruiting
NeuroClin Glasgow, Motherwell, United Kingdom · Recruiting
Cornwall Partnership NHS Foundation Trust, Redruth, United Kingdom · Recruiting
Local Institution - 2504, Sheffield, United Kingdom · Not yet recruiting
Local Institution - 2509, Stafford, United Kingdom · Withdrawn
Local Institution - 2503, Wolverhampton, United Kingdom · Not yet recruiting

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-09-28.