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)
NCT ID: NCT07011732
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
352 participants
INTERVENTIONAL
2025-07-10
2028-12-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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KarXT + KarX-EC
Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
Xanomeline Enteric Capsule
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
Xanomeline Enteric Capsule
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
ii) If no historical evidence available: A. A plasma biomarker will be assessed for eligibility if allowed per regulatory requirements. The test cutoff(s) will be based on diagnostic use approval.
B. If a plasma biomarker assay cannot be used or if the assay result is inconclusive, conduct one the following:
* Amyloid PET.
* Aβ42/40 ratio or pTau181/Aβ42 ratio in CSF using an HA-authorized diagnostic assay.
* Mini-Mental State Examination (MMSE) score of 5 to 22, inclusive, at Screening (Visit 1).
* Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to:
i) Attend all visits and report on participant's status. ii) Oversee participant compliance with medication and study procedures. iii) Participate in the study assessments and provide informed consent to participate in the study.
* History of agitation that meets the International Psychogeriatric Association (IPA) consensus definition for agitation in cognitive disorders with onset at least two weeks prior to Screening (Visit 1).
* AD participants are required to have NPI/NPI-NH Agitation/Aggression score ≥ 4 at Screening (Visit 1) and Baseline (Visit 2).
* CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2).
* At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity):
i) 1 or more aggressive behaviors occurring at least several times per week. ii) 2 or more aggressive behaviors occurring at least once or twice per week. iii) 3 or more aggressive behaviors occurring less than once per week.
Exclusion Criteria
ii) History of bipolar disorder, schizophrenia, or schizoaffective disorder. iii) History of (or at high risk for) urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
iv) Risk of suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSR.
\- Prior/Concomitant Therapy: i) Recent history of receiving monoamine oxidase inhibitors, anticonvulsants (eg, lamotrigine, divalproex), mood stabilizers (eg, lithium), tricyclic antidepressants (eg, imipramine, desipramine), or any other psychoactive medications except for as needed anxiolytics (eg, lorazepam).
A. Selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors taken at a stable dose for at least 8 weeks prior to Screening (Visit 1) may be permitted.
B. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
55 Years
90 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Imaging Endpoints
Scottsdale, Arizona, United States
Advanced Research Center (ARC) - Anaheim
Anaheim, California, United States
Kaizen Brain Center
La Jolla, California, United States
Local Institution - 1662
Pomona, California, United States
Torrance Clinical Research
Torrance, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
Local Institution - 1630
Colorado Springs, Colorado, United States
Local Institution - 1622
Maitland, Florida, United States
Local Institution - 1631
Maitland, Florida, United States
Local Institution - 1602
Miami, Florida, United States
Local Institution - 1618
Miami, Florida, United States
Hope Research Network - Miami
Miami, Florida, United States
Nuovida Research Center
Miami, Florida, United States
Local Institution - 1608
Ocala, Florida, United States
Combined Research Orlando (CRO)
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Local Institution - 1661
Savannah, Georgia, United States
Local Institution - 1655
Marrero, Louisiana, United States
CBH Health
Gaithersburg, Maryland, United States
Local Institution - 1663
Foxborough, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Mayflower Clinical Research
South Dartmouth, Massachusetts, United States
Local Institution - 1660
Springfield, Massachusetts, United States
Local Institution - 1665
Bloomfield Hills, Michigan, United States
Oakland Medical Research
Troy, Michigan, United States
Redbird Research
Las Vegas, Nevada, United States
Patient First MD
Middletown, New Jersey, United States
Local Institution - 1664
Princeton, New Jersey, United States
Local Institution - 1610
Inwood, New York, United States
Mid Hudson Medical Research
New Windsor, New York, United States
Local Institution - 1645
Woodmere, New York, United States
Local Institution - 1658
Woodmere, New York, United States
Local Institution - 1601
Monroe, North Carolina, United States
Local Institution - 1659
Centerville, Ohio, United States
Central States Research
Tulsa, Oklahoma, United States
Local Institution - 1652
Columbia, South Carolina, United States
Local Institution - 1653
Columbia, South Carolina, United States
Advanced Neurology Epilepsy and Sleep Center
El Paso, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Local Institution - 1646
Bennington, Vermont, United States
Local Institution - 1644
Seattle, Washington, United States
Kingfisher Cooperative
Spokane, Washington, United States
Local Institution - 1001
La Plata, Buenos Aires, Argentina
Local Institution - 1002
Mar del Plata, Buenos Aires, Argentina
Local Institution - 1006
Rosario, Santa Fe Province, Argentina
Local Institution - 1003
Buenos Aires, , Argentina
Local Institution - 1004
Córdoba, , Argentina
Instituto Privado Kremer
Córdoba, , Argentina
Local Institution - 1000
Córdoba, , Argentina
Local Institution - 1051
Brasília, Federal District, Brazil
Local Institution - 1052
Curitiba, Paraná, Brazil
Local Institution - 1053
Curitiba, Paraná, Brazil
Local Institution - 1058
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 1054
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 1057
Campinas, São Paulo, Brazil
Local Institution - 1056
São Paulo, São Paulo, Brazil
Local Institution - 1050
Rio de Janeiro, , Brazil
Local Institution - 1055
São Paulo, , Brazil
Local Institution - 1100
Sofia, Sofia-Grad, Bulgaria
Local Institution - 1101
Pleven, , Bulgaria
Outpatient Clinic for Individual Practice for Specialized Medical Care in Psychiatry - Dr. Madlena Dimitrova Borisova
Razgrad, , Bulgaria
Medical Center Mladost
Varna, , Bulgaria
Local Institution - 1153
Hamilton, Ontario, Canada
Local Institution - 1155
London, Ontario, Canada
Local Institution - 1755
London, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Local Institution - 1154
Toronto, Ontario, Canada
Ontario Shores Centre For Mental Health Sciences
Whitby, Ontario, Canada
Local Institution - 1150
Montreal, Quebec, Canada
Local Institution - 1805
Beijing, Beijing Municipality, China
Local Institution - 1810
Beijing, Beijing Municipality, China
Local Institution - 1815
Haidian District, Beijing Municipality, China
Local Institution - 1813
Chongqing, Chongqing Municipality, China
Local Institution - 1809
Guangzhou, Guangdong, China
Local Institution - 1802
Guangzhou, Guangdong, China
Local Institution - 1818
Shenzhen, Guangdong, China
Local Institution - 1803
Changsha, Hunan, China
Local Institution - 1801
Nanjing, Jiangsu, China
Local Institution - 1800
Shanghai, Shanghai Municipality, China
Local Institution - 1816
Xian, Shanxi, China
Local Institution - 1819
Chengdu, Sichuan, China
Local Institution - 1814
Tianjin, Tianjin Municipality, China
Local Institution - 1804
Hangzhou, Zhejiang, China
Local Institution - 1817
Hangzhou, , China
Local Institution - 1812
Kunming, , China
Local Institution - 1808
Tianjin, , China
Local Institution - 1550
Zagreb, City of Zagreb, Croatia
Local Institution - 1553
Zagreb, City of Zagreb, Croatia
Local Institution - 1554
Rijeka, , Croatia
Local Institution - 1551
Split, , Croatia
Local Institution - 1552
Varaždin, , Croatia
Local Institution - 1200
Pátrai, Achaḯa, Greece
Local Institution - 1205
Athens, Attica, Greece
Local Institution - 1202
Athens, Attica, Greece
Local Institution - 1206
Athens, , Greece
Local Institution - 1203
Athens, , Greece
Local Institution - 1207
Athens, , Greece
Local Institution - 1201
Ioannina, , Greece
Local Institution - 1204
Thessaloniki, , Greece
Local Institution - 1251
Hyderabad, Andhra Pradesh, India
Local Institution - 1255
Ahmedabad, Gujarat, India
Local Institution - 1252
Hyderabad, Telangana, India
Local Institution - 1254
Varanasi, Uttar Pradesh, India
Local Institution - 1250
Kolkata, West Bengal, India
Local Institution - 1256
Delhi, , India
Local Institution - 1253
New Delhi, , India
Local Institution - 1301
Hadano, Kanagawa, Japan
Teikyo University Mizonokuchi Hospital
Kawasaki, Kanagawa, Japan
Local Institution - 1304
Sakai, Osaka, Japan
National Hospital Organization Hizen Psychiatric Center
Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan
Local Institution - 1300
Karatsu-shi, Saga-ken, Japan
Local Institution - 1305
Bunkyo-ku, Tokyo, Japan
Local Institution - 1302
Fukuoka, , Japan
Local Institution - 1306
Okayama, , Japan
Local Institution - 1308
Shimotsuke-shi, Tochigi, , Japan
Local Institution - 1355
Saltillo, Coahuila, Mexico
Local Institution - 1356
Mexico City, Mexico City, Mexico
Local Institution - 1350
Monterrey, Nuevo León, Mexico
Local Institution - 1361
Mexico City, , Mexico
Local Institution - 1363
Mexico City, , Mexico
Local Institution - 1360
Mexico City, , Mexico
Local Institution - 1364
Monterrey, , Mexico
Local Institution - 1362
San Luis Potosí City, , Mexico
Local Institution - 1352
Tlalnepantla, , Mexico
Local Institution - 1401
Coimbra, , Portugal
Local Institution - 1402
Guimarães, , Portugal
Local Institution - 1404
Lisbon, , Portugal
Unidade Local de Saúde de Matosinhos SA
Senhora da Hora, , Portugal
Campus Neurologico Senior
Torres Vedras, , Portugal
Local Institution - 1450
Bucharest, București, Romania
Local Institution - 1453
Bucharest, București, Romania
Local Institution - 1454
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, Romania
Local Institution - 1451
Bucharest, , Romania
Local Institution - 1459
Bucharest, , Romania
Local Institution - 1461
Constanța, , Romania
Local Institution - 1457
Iași, , Romania
Local Institution - 1460
Sanpetru /Brasov, , Romania
Local Institution - 1462
Sibiu, , Romania
Oroitu Centro de Atencion Especializada
Getxo, Bizkaia, Spain
Hospital General Universitario de Elche
Elche (alicante), , Spain
Complejo Hospitalario Ruber Juan Bravo
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Clinico Universitario Virgen de La Victoria
Málaga, , Spain
Local Institution - 1507
Pamplona, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, , Spain
Hospital Victoria Eugenia de Sevilla
Seville, , Spain
Hospital Mutua Terrassa
Terrassa, , Spain
Hospital Universitario De Rio Hortega
Valladolid, , Spain
Hospital Viamed Montecanal
Zaragoza, , Spain
Local Institution - 1753
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiana, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Local Institution - 1752
Taoyuan District, , Taiwan
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Nida Laurin, Site 1619
Role: primary
Steven Macina, Site 1657
Role: primary
Janne Nissinen, Site 1637
Role: primary
Site 1662
Role: primary
Marina Raikhel, Site 1639
Role: primary
Ira Glick, Site 1651
Role: primary
Site 1622
Role: primary
Site 1631
Role: primary
Site 1602
Role: primary
Site 1618
Role: primary
Jorge Jorge, Site 1609
Role: primary
Jorge Betancourt, MD, Site 1604
Role: primary
Site 1608
Role: primary
Eric Carbonell, Site 1635
Role: primary
Alexander White, Site 1612
Role: primary
Site 1661
Role: primary
Site 1655
Role: primary
Elia Acevedo Diaz, Site 1636
Role: primary
Site 1663
Role: primary
Paul Solomon, Site 1638
Role: primary
Simon Desjardins, Site 1642
Role: primary
Site 1660
Role: primary
Site 1665
Role: primary
Jay Sandberg, Site 1620
Role: primary
Jelena Kunovac, Site 1649
Role: primary
Matthew Davis, Site 1647
Role: primary
Site 1664
Role: primary
Site 1610
Role: primary
Sashi Makam, Site 1656
Role: primary
Site 1658
Role: primary
Site 1601
Role: primary
Site 1659
Role: primary
Sarah Land, Site 1640
Role: primary
Site 1653
Role: primary
Aamr Herekar, Site 1643
Role: primary
Albert Jarvi, Site 1641
Role: primary
Site 1646
Role: primary
Site 1644
Role: primary
David Greeley, Site 1654
Role: primary
Site 1001
Role: primary
Site 1002
Role: primary
Site 1006
Role: primary
Site 1003
Role: primary
Site 1004
Role: primary
Leonardo Kremer, Site 1005
Role: primary
Site 1000
Role: primary
Site 1051
Role: primary
Site 1052
Role: primary
Site 1053
Role: primary
Site 1058
Role: primary
Site 1054
Role: primary
Site 1057
Role: primary
Site 1056
Role: primary
Site 1050
Role: primary
Site 1055
Role: primary
Site 1100
Role: primary
Site 1101
Role: primary
Madlena Borisova, Site 1103
Role: primary
Hristo Kozhuharov, Site 1102
Role: primary
Site 1153
Role: primary
Site 1155
Role: primary
Sandra Black, Site 1151
Role: primary
Site 1154
Role: primary
Amer Burhan, Site 1152
Role: primary
Site 1150
Role: primary
Site 1805
Role: primary
Site 1810
Role: primary
Site 1815
Role: primary
Site 1813
Role: primary
Site 1809
Role: primary
Site 1802
Role: primary
Site 1818
Role: primary
Site 1803
Role: primary
Site 1801
Role: primary
Site 1800
Role: primary
Site 1816
Role: primary
Site 1819
Role: primary
Site 1814
Role: primary
Site 1804
Role: primary
Site 1817
Role: primary
Site 1812
Role: primary
Site 1808
Role: primary
Site 1550
Role: primary
Site 1553
Role: primary
Site 1554
Role: primary
Site 1551
Role: primary
Site 1552
Role: primary
Site 1200
Role: primary
Site 1205
Role: primary
Site 1202
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Site 1206
Role: primary
Site 1203
Role: primary
Site 1207
Role: primary
Site 1201
Role: primary
Site 1204
Role: primary
Site 1251
Role: primary
Site 1255
Role: primary
Site 1252
Role: primary
Site 1254
Role: primary
Site 1250
Role: primary
Site 1256
Role: primary
Site 1253
Role: primary
Site 1301
Role: primary
Makoto Nakane, Site 1307
Role: primary
Site 1304
Role: primary
Manabu Hashimoto, Site 1303
Role: primary
Site 1300
Role: primary
Site 1305
Role: primary
Site 1302
Role: primary
Site 1306
Role: primary
Site 1308
Role: primary
Site 1355
Role: primary
Site 1356
Role: primary
Site 1350
Role: primary
Site 1361
Role: primary
Site 1363
Role: primary
Site 1360
Role: primary
Site 1364
Role: primary
Site 1362
Role: primary
Site 1352
Role: primary
Site 1401
Role: primary
Site 1402
Role: primary
Site 1404
Role: primary
Vitor Tedim Cruz, Site 1403
Role: primary
Camila Nóbrega, Site 1400
Role: primary
Site 1450
Role: primary
Site 1453
Role: primary
Site 1454
Role: primary
Laura Cristina Dolis, Site 1458
Role: primary
Corina Nicolae, Site 1456
Role: primary
SIMONA TRIFU, Site 1455
Role: primary
ADELA CIOBANU, Site 1452
Role: primary
Site 1451
Role: primary
Site 1459
Role: primary
Site 1461
Role: primary
Site 1457
Role: primary
Site 1460
Role: primary
Site 1462
Role: primary
Manuel Fernandez, Site 1510
Role: primary
Maria Gloria González Caballero, Site 1509
Role: primary
Juan Lopez Lozano, Site 1508
Role: primary
Jordi Matias Guiu, Site 1505
Role: primary
Carlos De La Cruz Cosme, Site 1502
Role: primary
Site 1507
Role: primary
Angel Luis Montejo, Site 1500
Role: primary
Felix Viñuela Fernandez, Site 1503
Role: primary
Jerzy Krupinski, Site 1504
Role: primary
Juan Muñoz Sanchez, Site 1506
Role: primary
Antonio Oliveros-Cid, Site 1501
Role: primary
Site 1753
Role: primary
Ming-Chyi Pai, Site 1751
Role: primary
Yi-Ting Lin, Site 1754
Role: primary
Jong-Ling Fuh, Site 1750
Role: primary
Site 1752
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2025-520613-31
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1316-5745
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0023
Identifier Type: -
Identifier Source: org_study_id
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