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A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)
NCT06937229 · Bristol-Myers Squibb
In plain English
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Official title
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)
About this study
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.
Eligibility criteria
Inclusion Criteria:
* 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).
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.
Study design
Enrollment target: 600 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-12-02
Estimated completion: 2029-07-20
Last updated: 2026-04-06
Interventions
Drug: KarXTDrug: KarX-EC
Primary outcomes
- • Number of Participants With Treatment Emergent Adverse Events (TEAEs) (Up to approximately Week 30)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com, www.BMSStudyConnect.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (240)
Local Institution - 2609Not Yet Recruiting
Chandler, Arizona, United States
Imaging EndpointsRecruiting
Scottsdale, Arizona, United States
Local Institution - 1657Not Yet Recruiting
Anaheim, California, United States
Local Institution - 2620Not Yet Recruiting
Canoga Park, California, United States
Local Institution - 1637Not Yet Recruiting
La Jolla, California, United States
Local Institution - 2625Not Yet Recruiting
Long Beach, California, United States
Local Institution - 2607Not Yet Recruiting
Long Beach, California, United States
Local Institution - 2642Not Yet Recruiting
Long Beach, California, United States
Local Institution - 2613Not Yet Recruiting
Pasadena, California, United States
Local Institution - 1662Not Yet Recruiting
Pomona, California, United States
Local Institution - 1651Not Yet Recruiting
Walnut Creek, California, United States
Local Institution - 2602Not Yet Recruiting
Bonita Springs, Florida, United States
Local Institution - 2626Not Yet Recruiting
Hialeah, Florida, United States
Local Institution - 1602Not Yet Recruiting
Miami, Florida, United States
Local Institution - 1618Not Yet Recruiting
Miami, Florida, United States
Local Institution - 1609Not Yet Recruiting
Miami, Florida, United States
Nuovida Research CenterRecruiting
Miami, Florida, United States
Local Institution - 1635Not Yet Recruiting
Orlando, Florida, United States
Progressive Medical ResearchRecruiting
Port Orange, Florida, United States
IPTB Clinical ResearchRecruiting
Tampa, Florida, United States
Local Institution - 1636Not Yet Recruiting
Gaithersburg, Maryland, United States
Boston Center for MemoryRecruiting
Newton, Massachusetts, United States
Local Institution - 2615Not Yet Recruiting
Worcester, Massachusetts, United States
Local Institution - 2618Not Yet Recruiting
Ann Arbor, Michigan, United States
Local Institution - 1620Not Yet Recruiting
Troy, Michigan, United States
Local Institution - 2256Not Yet Recruiting
Saint Paul, Minnesota, United States
Local Institution - 2629Not Yet Recruiting
Hattiesburg, Mississippi, United States
Local Institution - 2628Not Yet Recruiting
Las Vegas, Nevada, United States
Local Institution - 1649Not Yet Recruiting
Las Vegas, Nevada, United States
Local Institution - 1647Not Yet Recruiting
West Long Branch, New Jersey, United States
Local Institution - 1656Not Yet Recruiting
New Windsor, New York, United States
Local Institution - 2619Not Yet Recruiting
Staten Island, New York, United States
Local Institution - 1658Not Yet Recruiting
Woodmere, New York, United States
West Clinical ResearchRecruiting
Morehead City, North Carolina, United States
Local Institution - 2617Not Yet Recruiting
Blue Ash, Ohio, United States
Local Institution - 1640Not Yet Recruiting
Tulsa, Oklahoma, United States
Local Institution - 1653Not Yet Recruiting
Columbia, South Carolina, United States
Epic Medical Research, LLC - CarroltonRecruiting
Carrollton, Texas, United States
Local Institution - 2605Not Yet Recruiting
Cypress, Texas, United States
Local Institution - 1643Not Yet Recruiting
El Paso, Texas, United States
Local Institution - 2622Not Yet Recruiting
Mesquite, Texas, United States
Local Institution - 2623Not Yet Recruiting
San Antonio, Texas, United States
Pantheon Clinical Research, LLCRecruiting
Bountiful, Utah, United States
Local Institution - 1646Not Yet Recruiting
Bennington, Vermont, United States
Local Institution - 1644Not Yet Recruiting
Seattle, Washington, United States
Local Institution - 1654Not Yet Recruiting
Spokane, Washington, United States
Local Institution - 2610Not Yet Recruiting
Milwaukee, Wisconsin, United States
Local Institution - 2005Not Yet Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 1001Not Yet Recruiting
La Plata, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
Local Institution - 2006Not Yet Recruiting
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 1006Not Yet Recruiting
Rosario, Santa Fe Province, Argentina
Local Institution - 2004Not Yet Recruiting
Buenos Aires, Argentina
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Buenos Aires, Argentina
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Córdoba, Argentina
Local Institution - 2000Not Yet Recruiting
Córdoba, Argentina
Local Institution - 2002Not Yet Recruiting
Córdoba, Argentina
Local Institution - 1005Not Yet Recruiting
Córdoba, Argentina
Local Institution - 1000Not Yet Recruiting
Córdoba, Argentina
Local Institution - 2003Not Yet Recruiting
Córdoba, Argentina
Local Institution - 2001Not Yet Recruiting
Mendoza, Argentina
Local Institution - 1051Not Yet Recruiting
Brasília, Federal District, Brazil
Local Institution - 1052Not Yet Recruiting
Curitiba, Paraná, Brazil
Local Institution - 1053Not Yet Recruiting
Curitiba, Paraná, Brazil
Local Institution - 1058Not Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 1054Not Yet Recruiting
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 1057Not Yet Recruiting
Campinas, São Paulo, Brazil
Local Institution - 1050Not Yet Recruiting
Rio de Janeiro, Brazil
Local Institution - 1055Not Yet Recruiting
São Paulo, Brazil
Local Institution - 1056Not Yet Recruiting
São Paulo, Brazil
Local Institution - 1100Not Yet Recruiting
Sofia, Sofia-Grad, Bulgaria
Local Institution - 1101Not Yet Recruiting
Pleven, Bulgaria
Local Institution - 1103Not Yet Recruiting
Razgrad, Bulgaria
Local Institution - 1102Not Yet Recruiting
Varna, Bulgaria
Local Institution - 1153Not Yet Recruiting
Hamilton, Ontario, Canada
Local Institution - 1155Not Yet Recruiting
London, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Whitby, Ontario, Canada
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Santiago, Santiago Metropolitan, Chile
Local Institution - 2052Not Yet Recruiting
Santiago, Santiago Metropolitan, Chile
Local Institution - 2054Not Yet Recruiting
Vitacura, Santiago Metropolitan, Chile
Local Institution - 2055Not Yet Recruiting
Viña del Mar, Valparaiso, Chile
Local Institution - 2053Not Yet Recruiting
Antofagasta, Chile
Local Institution - 1553Not Yet Recruiting
Zagreb, City of Zagreb, Croatia
Local Institution - 1554Not Yet Recruiting
Rijeka, Croatia
Local Institution - 1551Not Yet Recruiting
Split, Croatia
Local Institution - 1552Not Yet Recruiting
Varaždin, Croatia
Local Institution - 1550Not Yet Recruiting
Zagreb, Croatia
Local Institution - 2107Not Yet Recruiting
Olomouc, Olomouc Region, Czechia
Local Institution - 2100Not Yet Recruiting
Prague, Praha 6, Czechia
Local Institution - 2106Not Yet Recruiting
Prague, Praha 8, Czechia
Local Institution - 2103Not Yet Recruiting
Brno, South Moravian, Czechia
Local Institution - 2101Not Yet Recruiting
Choceň, Czechia
Local Institution - 2104Not Yet Recruiting
Pilsen, Czechia
Local Institution - 2102Withdrawn
Prague, Czechia
Local Institution - 2105Withdrawn
Prague, Czechia
Local Institution - 2108Not Yet Recruiting
Rychnov nad Kněžnou, Czechia
Local Institution - 2150Not Yet Recruiting
Toulouse, Haute-Garonne, France
Local Institution - 2151Not Yet Recruiting
Villeurbanne, Rhône, France
Local Institution - 2153Not Yet Recruiting
Lille, France
Local Institution - 2156Not Yet Recruiting
Limoges, France
Local Institution - 2157Not Yet Recruiting
Montpellier, France
Local Institution - 2152Not Yet Recruiting
Paris, France
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Strasbourg, France
Local Institution - 2201Not Yet Recruiting
Düsseldorf, Germany
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Halle, Germany
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Westerstede, Germany
Local Institution - 1200Not Yet Recruiting
Pátrai, Achaḯa, Greece
Local Institution - 1205Not Yet Recruiting
Athens, Attica, Greece
Local Institution - 1202Not Yet Recruiting
Athens, Attica, Greece
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Chaïdári, Attikí, Greece
Local Institution - 0027Withdrawn
Athens, Greece
Local Institution - 1206Not Yet Recruiting
Athens, Greece
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Athens, Greece
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Ioannina, Greece
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Thessaloniki, Greece
Local Institution - 2257Not Yet Recruiting
Kalocsa, Bács-Kiskun county, Hungary
Local Institution - 2250Not Yet Recruiting
Győr, Győr-Moson-Sopron, Hungary
Local Institution - 2254Not Yet Recruiting
Gyöngyös, Heves County, Hungary
Local Institution - 2255Not Yet Recruiting
Budapest, Hungary
Local Institution - 2251Withdrawn
Budapest, Hungary
Local Institution - 2253Not Yet Recruiting
Budapest, Hungary
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Debrecen, Hungary
Local Institution - 1251Not Yet Recruiting
Hyderabad, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Hyderabad, Telangana, India
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Varanasi, Uttar Pradesh, India
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Kolkata, West Bengal, India
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Delhi, India
Local Institution - 1253Not Yet Recruiting
New Delhi, India
Local Institution - 2302Not Yet Recruiting
Petch Tikva, IL, Israel
Local Institution - 2301Not Yet Recruiting
Jerusalem, Israel
Local Institution - 2303Not Yet Recruiting
Netanya, Israel
Local Institution - 2305Not Yet Recruiting
Ramat Gan, Israel
Local Institution - 2300Not Yet Recruiting
Ramat Gan, Israel
Local Institution - 2304Not Yet Recruiting
Rishon Le'Tzion, Israel
Local Institution - 2351Not Yet Recruiting
Naples, Campania, Italy
Local Institution - 2354Not Yet Recruiting
Rome, Lazio, Italy
Local Institution - 2352Not Yet Recruiting
Rome, Lazio, Italy
Local Institution - 2353Not Yet Recruiting
Milan, Lombardy, Italy
Local Institution - 2350Not Yet Recruiting
Pisa, PI, Italy
Local Institution - 2356Not Yet Recruiting
Brescia, Italy
Local Institution - 2355Withdrawn
Isernia, Italy
Local Institution - 2357Not Yet Recruiting
Roma, Italy
Local Institution - 1301Not Yet Recruiting
Hadano, Kanagawa, Japan
Local Institution - 1307Not Yet Recruiting
Kawasaki, Kanagawa, Japan
Local Institution - 1304Not Yet Recruiting
Sakai, Osaka, Japan
National Hospital Organization Hizen Psychiatric CenterRecruiting
Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan
Rainbow and Sea HospitalRecruiting
Karatsu-shi, Saga-ken, Japan
Local Institution - 1305Not Yet Recruiting
Bunkyo-ku, Tokyo, Japan
Kuramitsu HospitalRecruiting
Fukuoka, Japan
Okayama City General Medical Center Okayama City HospitalRecruiting
Okayama, Japan
Local Institution - 1308Not Yet Recruiting
Shimotsuke-shi, Tochigi, Japan
Local Institution - 1355Not Yet Recruiting
Saltillo, Coahuila, Mexico
Local Institution - 1356Not Yet Recruiting
Guadalajara, Jalisco, Mexico
Local Institution - 1363Not Yet Recruiting
Mexico City, Mexico City, Mexico
Local Institution - 1360Not Yet Recruiting
Mexico City, Mexico City, Mexico
Local Institution - 1364Not Yet Recruiting
Monterrey, Nuevo León, Mexico
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Monterrey, Nuevo León, Mexico
Local Institution - 1361Not Yet Recruiting
Mexico City, Mexico
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San Luis Potosí City, Mexico
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Tlalnepantla, Mexico
Local Institution - 2450Not Yet Recruiting
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 2454Not Yet Recruiting
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 2456Not Yet Recruiting
Chorzów, Poland
Local Institution - 2455Not Yet Recruiting
Katowice, Poland
Local Institution - 2451Withdrawn
Lublin, Poland
Local Institution - 2452Withdrawn
Lublin, Poland
Local Institution - 2453Not Yet Recruiting
Sochaczew, Poland
Local Institution - 1401Not Yet Recruiting
Coimbra, Portugal
Local Institution - 1402Not Yet Recruiting
Guimarães, Portugal
Local Institution - 1404Not Yet Recruiting
Lisbon, Portugal
Local Institution - 1403Not Yet Recruiting
Senhora da Hora, Portugal
Local Institution - 1400Not Yet Recruiting
Torres Vedras, Portugal
Local Institution - 1450Not Yet Recruiting
Bucharest, Bucharest, Romania
Local Institution - 1452Not Yet Recruiting
Bucharest, Bucharest, Romania
Local Institution - 1453Not Yet Recruiting
Bucharest, Bucharest, Romania
Local Institution - 1454Not Yet Recruiting
Bucharest, Bucharest, Romania
Local Institution - 1455Not Yet Recruiting
Bucharest, Bucharest, Romania
Local Institution - 1456Not Yet Recruiting
Bucharest, Bucharest, Romania
Local Institution - 1458Not Yet Recruiting
Bucharest, Bucharest, Romania
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Bucharest, Romania
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Bucharest, Romania
Local Institution - 1461Not Yet Recruiting
Constanța, Romania
Local Institution - 1457Not Yet Recruiting
Iași, Romania
Local Institution - 1460Not Yet Recruiting
Sanpetru /Brasov, Romania
Local Institution - 1462Not Yet Recruiting
Sibiu, Romania
Local Institution - 2401Not Yet Recruiting
Incheon, Incheon Gwang'yeogsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 2403Not Yet Recruiting
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 2406Withdrawn
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 2400Not Yet Recruiting
Deagu, Taegu-Kwangyǒkshi, South Korea
Local Institution - 2409Not Yet Recruiting
Incheon, South Korea
Local Institution - 2402Not Yet Recruiting
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Local Institution - 2405Not Yet Recruiting
Seoul, South Korea
The Catholic University of Korea, Yeouido St.Mary's HospitalRecruiting
Seoul, South Korea
Local Institution - 1510Not Yet Recruiting
Getxo, Bizkaia, Spain
Local Institution - 1509Not Yet Recruiting
Elche (alicante), Spain
Local Institution - 1508Not Yet Recruiting
Madrid, Spain
Local Institution - 1505Not Yet Recruiting
Madrid, Spain
Local Institution - 0003Withdrawn
Málaga, Spain
Local Institution - 1502Not Yet Recruiting
Málaga, Spain
Local Institution - 1507Not Yet Recruiting
Pamplona, Spain
Local Institution - 1500Not Yet Recruiting
Salamanca, Spain
Local Institution - 1503Not Yet Recruiting
Seville, Spain
Local Institution - 1504Not Yet Recruiting
Terrassa, Spain
Local Institution - 1506Not Yet Recruiting
Valladolid, Spain
Local Institution - 1501Not Yet Recruiting
Zaragoza, Spain
Local Institution - 1753Not Yet Recruiting
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Local Institution - 1751Not Yet Recruiting
Tainan, Taiana, Taiwan
Local Institution - 1754Not Yet Recruiting
Taipei, Taiwan
Local Institution - 1750Not Yet Recruiting
Taipei, Taiwan
Local Institution - 1752Not Yet Recruiting
Taoyuan District, Taiwan
Local Institution - 2555Not Yet Recruiting
Smila, Cherkasy Oblast, Ukraine
Local Institution - 2554Not Yet Recruiting
Dnipro, Dnipropetrovsk Oblast, Ukraine
Local Institution - 2566Not Yet Recruiting
Hlevakha, Kyiv Oblast, Ukraine
Local Institution - 2552Not Yet Recruiting
Lviv, Lviv Oblast, Ukraine
Local Institution - 2558Not Yet Recruiting
Lviv, Lviv Oblast, Ukraine
Local Institution - 2569Not Yet Recruiting
Lviv, Lviv Oblast, Ukraine
Local Institution - 2567Not Yet Recruiting
Oleksandrivka, Odesa Oblast, Ukraine
Local Institution - 2551Not Yet Recruiting
Vinnytsia, Vinnytsia Oblast, Ukraine
Local Institution - 2556Not Yet Recruiting
Hlevakha, Ukraine
Local Institution - 2550Not Yet Recruiting
Kropyvnytskyi, Ukraine
Local Institution - 2565Not Yet Recruiting
Kyiv, Ukraine
Local Institution - 2553Not Yet Recruiting
Kyiv, Ukraine
Local Institution - 2568Not Yet Recruiting
Odesa, Ukraine
Local Institution - 2557Not Yet Recruiting
Poltava, Ukraine
Local Institution - 2559Not Yet Recruiting
Skarzhyntsi, Ukraine
Local Institution - 2505Not Yet Recruiting
Preston, Lancashire, United Kingdom
Surrey and Borders Partnership NHS Foundation TrustRecruiting
Chertsey, Surrey, United Kingdom
Local Institution - 2502Not Yet Recruiting
Cambridge, United Kingdom
Local Institution - 2501Not Yet Recruiting
London, United Kingdom
Local Institution - 2500Not Yet Recruiting
London, United Kingdom
Local Institution - 2510Not Yet Recruiting
Motherwell, United Kingdom
Local Institution - 2507Not Yet Recruiting
Redruth, United Kingdom
Local Institution - 2504Not Yet Recruiting
Sheffield, United Kingdom
Local Institution - 2509Withdrawn
Stafford, United Kingdom
Local Institution - 2503Not Yet Recruiting
Wolverhampton, United Kingdom