Alzheimer DiseasePhase 3NCT07011732
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)
A Phase 3 study testing Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule in people with Alzheimer Disease, run by Bristol-Myers Squibb at 162 sites in 15 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Xanomeline/Trospium Chloride Capsule and Xanomeline Enteric Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 426 participants
- Where
- 162 sitesin 15 countries
- Study dates
- 10 Jul 2025to 8 Dec 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of Alzheimer's disease (AD) in accordance with the 2024 Alzheimer's Association criteria with one of the following confirmations of AD pathology: i) Historical evidence of AD diagnosis with amyloid positron emission tomography (PET), Aβ42/40 ratio in CSF, pTau181/Aβ42 ratio in CSF or pTau217/Aβ42 ratio in plasma using an Health Authority (HA)-authorized diagnostic assay.
- 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.
- 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 ≤ 24 at Screening (Visit 1).
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- Have an identified caregiver who has sufficient contact (approximately 8 hours over a week) and is willing to:
- 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).
- CMAI-IPA Total Score ≥ 30 at Screening (Visit 1) and Baseline (Visit 2).
Who cannot join
- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia.
- 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.
- 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).
- 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.
- Trazodone may be used as a hypnotic or for agitation if started at least 8 weeks prior to Screening (Visit 1).
- Mirtazapine may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
162 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
162 sites in 15 countries
United States41 sites, 33 recruiting
- Recruiting
Advanced Research Center (ARC) - Anaheim
Anaheim, California, 92805
Steven Macina, Site 1657, 714-999-6688
- Recruiting
The Memory Clinic
Bennington, Vermont, 05201-9810
Lisa Catapano-Friedman, Site 1646, 413-281-0575
- Recruiting
NeuroBehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
Richard Jackson, Site 1665, 412-916-2425
- Withdrawn
Local Institution - 1630
Colorado Springs, Colorado, 80907
- Withdrawn
Local Institution - 1652
Columbia, South Carolina, 29205
- Recruiting
Advanced Neurology Epilepsy and Sleep Center
El Paso, Texas, 79902
Aamr Herekar, Site 1643, 505-903-1715
- Not yet recruiting
Local Institution - 1663
Foxborough, Massachusetts, 02035-1309
Site 1663
- Not yet recruiting
Local Institution - 1668
Fresno, California, 93710
Site 1668
- Recruiting
CBH Health
Gaithersburg, Maryland, 20877
Elia Acevedo Diaz, Site 1636, 301-251-4702
- Not yet recruiting
Local Institution - 1610
Inwood, New York, 11096
Site 1610
- Completed
Local Institution - 1637
La Jolla, California, 92037
- Recruiting
Redbird Research
Las Vegas, Nevada, 89119
Jelena Kunovac, Site 1649, 760-758-2222
- Not yet recruiting
Local Institution - 1622
Maitland, Florida, 32751
Site 1622
- Not yet recruiting
Local Institution - 1631
Maitland, Florida, 32751
Site 1631
- Not yet recruiting
Local Institution - 1655
Marrero, Louisiana, 70072
Site 1655
- Recruiting
Flourish Research
Merritt Island, Florida, 32952
David Kirk, Site 1666, 321-305-5015
- Not yet recruiting
Local Institution - 1602
Miami, Florida, 33122
Site 1602
- Not yet recruiting
Local Institution - 1618
Miami, Florida, 33135
Site 1618
- Completed
Local Institution - 1604
Miami, Florida, 33186
- Completed
Local Institution - 1647
Middletown, New Jersey, 07748
- Recruiting
Mid Hudson Medical Research
New Windsor, New York, 12553
Sashi Makam, Site 1656, 845-674-9398
- Recruiting
Boston Center for Memory
Newton, Massachusetts, 02459
Paul Solomon, Site 1638, 413-281-0577
- Not yet recruiting
Local Institution - 1608
Ocala, Florida, 34471
Site 1608
- Recruiting
Combined Research Orlando (CRO)
Orlando, Florida, 32807
Eric Carbonell, Site 1635, 407-440-4493
- Recruiting
The Neurology Group
Pomona, California, 91767
Sadiq Altamimi, Site 1662
- Recruiting
Progressive Medical Research
Port Orange, Florida, 32127
Alexander White, Site 1612, 386-304-7070
- Recruiting
Global Medical Institutes LLC; Princeton Medical Institute
Princeton, New Jersey, 08540
Matthew Adasofunjo, Site 1664
- Recruiting
Wasatch Clinical Research, LLC
Salt Lake City, Utah, 84107
Albert Jarvi, Site 1641, 801-288-0607
- Recruiting
Imaging Endpoints
Scottsdale, Arizona, 85258
Nida Laurin, Site 1619, 480-290-1547
- Not yet recruiting
Local Institution - 1644
Seattle, Washington, 98122
Site 1644
- Recruiting
Mayflower Clinical Research
South Dartmouth, Massachusetts, 02747
Mushtaque Chachar, Site 1642, 508-925-7403
- Completed
Local Institution - 1654
Spokane, Washington, 99201
- Recruiting
Voltaire Springfield
Springfield, Massachusetts, 01103
Brittany Perreault, Site 1660
- Not yet recruiting
Local Institution - 1667
St Louis, Missouri, 63128
Site 1667
- Active, not recruiting
Local Institution - 1639
Torrance, California, 90505
- Recruiting
Oakland Medical Research
Troy, Michigan, 48085
Jay Sandberg, Site 1620, 248-687-7412
- Recruiting
Central States Research
Tulsa, Oklahoma, 74136
Sarah Land, Site 1640, 918-645-5400
- Recruiting
Hope Research Network - Miami
Virginia Gardens, Florida, 33166
Jorge Jorge, Site 1609, 786-681-4959
- Recruiting
Sunwise Clinical Research
Walnut Creek, California, 94596
Ira Glick, Site 1651, 925-298-5147
- Recruiting
Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere, New York, 11598-1739
David Steiner, Site 1658, 516-239-1800
- Withdrawn
Local Institution - 1645
Woodmere, New York, 11598-1739
China18 sites, 16 recruiting
- Recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, 100053
Yi Tang, Site 1805, +8613811021432
- Recruiting
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, 100088
Qinge Zhang, Site 1810
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410008
Lu Shen, Site 1803, 073189753041
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Weihong Kuang, Site 1819, +861898060171
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014
Yang Lv, Site 1813, +861361823653
- Recruiting
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 0
Yuping Ning, Site 1809, +861392221423
- Recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou Province, 510260
Jun Liu, Site 1802, +862081332621
- Recruiting
Peking University Sixth Hospital
Haidian District, Beijing Municipality, 100191
Huali Wang, Site 1815, +86-10-82806167
- Recruiting
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310003
Ning Wei, Site 1804, +86 13957162835
- Recruiting
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, 310016
Wei Chen, Site 1817, +86 138 0573 6335
- Recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming, 650032
Jin Lu, Site 1812, 8613944802410
- Recruiting
Nanjing Drum Tower hospital
Nanjing, Jiangsu, 210008
Yun Xu, Site 1801, +86 13914764479
- Withdrawn
Local Institution - 1800
Shanghai, Shanghai Municipality, 200025
- Not yet recruiting
Local Institution - 1811
Shanghai, Shanghai Municipality, 200065
Site 1811
- Recruiting
Shenzhen Kangning Hospital
Shenzhen, Guangdong, 518118
Yongjun Wang, Site 1818, 8613632587615
- Recruiting
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300074
Jie Li, Site 1814, +862288188006
- Withdrawn
Local Institution - 1808
Tianjin, 300350
- Recruiting
Mental Health Center of Xi'an City
Xian, Shanxi, 710061
Wei Dang, Site 1816
Romania15 sites, 13 recruiting
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041919
Laura Cristina Dolis, Site 1458, 0040757243543
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041919
Corina Nicolae, Site 1456, +40727818190
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041919
SIMONA TRIFU, Site 1455, 0040731581100
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041919
Mihnea Manea, Site 1454, 0040745974029
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041919
Valentin Matei, Site 1453, +40721243869
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041919
ADELA CIOBANU, Site 1452, 0040723671301
- Withdrawn
Local Institution - 1451
Bucharest, 010825
- Not yet recruiting
Local Institution - 1463
Bucharest, 011241
Site 1463
- Withdrawn
Local Institution - 1459
Bucharest, 060222
- Recruiting
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital- Centrul de Sanatate Mintala
Bucharest, 40874
Mihaela Rosca, Site 1450, +40745588989
- Recruiting
Cai Ferate Clinical Hospital Constanta
Constanța, 90123
Ana-Maria Ionescu, Site 1461, 4024151078x3
- Recruiting
Institutul de Psihiatrie Socola
Iași, 700282
CRISTINEL STEFANESCU, Site 1457, +40744518195
- Recruiting
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, 507190
Petru Iulian Ifteni, Site 1460, 40724993329
- Not yet recruiting
Local Institution - 1464
Sibiu, 550052
Site 1464
- Recruiting
Clinical Psychiatric Hospital "Dr. Gheorghe Preda"
Sibiu, 550082
Ciprian Bacila, Site 1462, +40723000227
Spain11 sites, 11 recruiting
- Recruiting
Hospital General Universitario de Elche
Elche (alicante), 03203
Maria Gloria González Caballero, Site 1509, 966 616 805
- Recruiting
Oroitu CAE
Getxo, Bizkaia, 48993
Manuel Fernandez, Site 1510, +34 630 070 877
- Recruiting
Complejo Hospitalario Ruber Juan Bravo
Madrid, 28006
Juan Lopez Lozano, Site 1508, +34914211218
- Recruiting
Hospital Clinico San Carlos
Madrid, 28040
Jordi Matias Guiu, Site 1505
- Recruiting
Hospital Clinico Universitario Virgen de La Victoria
Málaga, 29010
Carlos De La Cruz Cosme, Site 1502, 675 486 977
- Recruiting
Clinica Universidad de Navarra
Pamplona, 31008
Mario Riverol Fernandez, Site 1507, +34948255400
- Recruiting
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
Salamanca, 37007
Angel Luis Montejo, Site 1500, +34639754620
- Recruiting
Hospital Victoria Eugenia de Sevilla
Seville, 41009
Felix Vinuela Fernandez, Site 1503, +34654566812
- Recruiting
Hospital Mutua Terrassa
Terrassa, 8221
Jerzy Krupinski, Site 1504, +34937365050ext13939
- Recruiting
Hospital Universitario De Rio Hortega
Valladolid, 47012
Juan Muñoz Sanchez, Site 1506, +34679279973
- Recruiting
Hospital Viamed Montecanal
Zaragoza, 50012
Antonio Oliveros-Cid, Site 1501, +34670492099
Brazil9 sites, 9 recruiting
- Recruiting
L2IP - Instituto de Pesquisas Clínicas
Brasília, Federal District, 70200730
Eduardo Vasconcellos, Site 1051, 55-6199983-1080
- Recruiting
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080
Alexandre Pieri, Site 1057, (5519)32670023
- Recruiting
CECPAR - Centro de Estudos Clínicos do Paraná
Curitiba, Paraná, 80030-310
Luiz Petry, Site 1053, +5541988668732
- Recruiting
PUCTrials
Curitiba, Paraná, 80230-130
Carlos Twardowschy, Site 1052, 5541999260355
- Recruiting
Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001
Clarissa Gama, Site 1058, +55 51 999885851
- Recruiting
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-032
Wyllians Borelli, Site 1054, 5551991019123
- Recruiting
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
Sandra Ruschel, Site 1050, 5521999822072
- Recruiting
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Leonel Takada, Site 1055, 5511971539018
- Recruiting
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, 04020-060
Claudiane Daltion, Site 1056, 551159087222
Japan9 sites, 9 recruiting
- Recruiting
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
Amane Tateno, Site 1305
- Recruiting
Kuramitsu Hospital
Fukuoka, 819-0037
Noriko Tamaru, Site 1302, +81-92-811-1821
- Recruiting
Hatano Kousei Hospital
Hadano, Kanagawa, 257-0003
Sakai Yoshiro, Site 1301
- Recruiting
National Hospital Organization Hizen Psychiatric Center
Kanzaki-Gun Yoshinogari-Cho, Saga-ken, 842-0192
Manabu Hashimoto, Site 1303, 0952523231
- Recruiting
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, 847-0031
Taro Shindo, Site 1300, 0955770711
- Recruiting
Teikyo University Mizonokuchi Hospital
Kawasaki, Kanagawa, 213-8507
Makoto Nakane, Site 1307
- Recruiting
Okayama City General Medical Center Okayama City Hospital
Okayama, 700-8557
Kentaro Deguchi, Site 1306
- Recruiting
Asakayama Hospital
Sakai, Osaka, 590-0018
Kazue Kamae, Site 1304, 0722294882
- Recruiting
Jichi Medical University Hospital
Shimotsuke-shi, Tochigi, 329-0498
Shiro Suda, Site 1308, 81285442111
Mexico9 sites, 9 recruiting
- Recruiting
Boca Clinical Trials Mexico S.C.
Guadalajara, Jalisco, 44600
Hector Cruz, Site 1356, 3316546308
- Recruiting
Innovacion y Desarrollo en Ciencias de la Salud
Mexico City, Mexico City, 14090
Virgilio Hernandez Ruiz, Site 1363
- Not yet recruiting
Local Institution - 1360
Mexico City, Mexico City, 14269
Site 1360
- Not yet recruiting
Local Institution - 1361
Mexico City, 10200
Site 1361
- Recruiting
AVIX Investigacion Clinica
Monterrey, Nuevo León, 64623
Amador Macias, Site 1364, 5218182528996
- Not yet recruiting
Local Institution - 1350
Monterrey, Nuevo León, 66460
Site 1350
- Recruiting
Hospital Universitario de Saltillo
Saltillo, Coahuila, 25000
MARIO VALDES, Site 1355, +5218441258992
- Recruiting
Neurociencias PRISMA A.C.
San Luis Potosí City, 78216
Carlos Guerra Galicia, Site 1362
- Recruiting
Clinical Research Institute S.C.
Tlalnepantla, 54055
DANIEL ORTA, Site 1352, 525553627780
Greece8 sites, 8 recruiting
- Recruiting
Henry Dunant Hospital Center
Athens, Attica, 115 26
Konstantina Yiannopoulou, Site 1205, +302107796309
- Recruiting
Aiginiteio University Hospital
Athens, Attikí, 115 28
Nikolaos Scarmeas, Site 1206
- Recruiting
Eginition Hospital
Athens, 11528
NIKOS STEFANIS, Site 1202, +306936608887
- Recruiting
Athens Medical Center
Athens, 15125
John Papatriantafyllou, Site 1207
- Recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, 124 62
Georgios Tsivgoulis, Site 1203, +302105832473
- Not yet recruiting
Local Institution - 1201
Ioannina, 45500
Site 1201
- Recruiting
University Hospital of Patras
Pátrai, Achaḯa, 26504
John Ellul, Site 1200, +306932447636
- Recruiting
Euromedica General Clinic of Thessaloniki
Thessaloniki, 54645
Magda Tsolaki, Site 1204, +30 694 291 8933
Argentina7 sites, 7 recruiting
- Recruiting
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
Buenos Aires, C1428AQK
Ricardo Allegri, Site 1003, 5491144704855
- Recruiting
CEN Centro Especializado en Neurociencias
Córdoba, Córdoba Province, 5004
Hernan Ruggeri, Site 1004, 93515339477
- Recruiting
Instituto Privado Kremer
Córdoba, 5004
Leonardo Kremer, Site 1005, 543515000000
- Recruiting
Centro Medico Luquez
Córdoba, 5006
Juan Luquez, Site 1000, +5493517481586
- Not yet recruiting
Local Institution - 1001
La Plata, Buenos Aires, 1900
Site 1001
- Not yet recruiting
Local Institution - 1002
Mar del Plata, Buenos Aires, B7602CBM
Site 1002
- Recruiting
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Javier Travella, Site 1006
Canada7 sites, 6 recruiting
- Not yet recruiting
Local Institution - 1153
Hamilton, Ontario, L8M 1W9
Site 1153
- Withdrawn
Local Institution - 1755
London, Ontario, N6A 5W9
- Recruiting
London Health Sciences Centre-Victoria Campus
London, Ontario, N6A 5W9
Tuoyo Awani, Site 1155, 519-685-8500 x77024
- Not yet recruiting
Local Institution - 1150
Montreal, Quebec, H4A 3T2
Site 1150
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Sandra Black, Site 1151, 416-480-6100 x4551
- Recruiting
Centre for Addiction & Mental Health
Toronto, Ontario, M6J 1H4
Sanjeev Kumar, Site 1154, 416-535-8501 x32589
- Recruiting
Ontario Shores Centre For Mental Health Sciences
Whitby, Ontario, L1N 5S9
Amer Burhan, Site 1152, 905-430-4055 x6268
India7 sites, 7 recruiting
- Not yet recruiting
Local Institution - 1255
Ahmedabad, Gujarat, 380060
Site 1255
- Not yet recruiting
Local Institution - 1256
Delhi, 110 095
Site 1256
- Recruiting
Yashoda Hospitals
Hyderabad, Telangana, 500082
Jaydip Chaudhuri, Site 1252
- Recruiting
Asha Hospital
Hyderabad, 500034
G Rao, Site 1251, 9985900005
- Recruiting
Apollo Multispeciality Hospitals limited
Kolkata, West Bengal, 700054
AMITABHA GHOSH, Site 1250, 9830119686
- Not yet recruiting
Local Institution - 1253
New Delhi, 110029
Site 1253
- Recruiting
Deva Institute Of Healthcare & Research Pvt. Ltd.
Varanasi, Uttar Pradesh, 221005
Venu Jhanwar, Site 1254, +91-9935571052
Croatia6 sites, 6 recruiting
- Recruiting
Klinicki Bolnicki Centar Rijeka
Rijeka, 51000
Vladimir Sabljic, Site 1554, +385 98 369 555
- Recruiting
Clinical Hospital Center Split
Split, HR-21000
Trpimir Glavina, Site 1551, 38598422557
- Recruiting
General Hospital Varazdin
Varaždin, 42000
Spomenka Kidemet-Piskac, Site 1552
- Not yet recruiting
Local Institution - 1550
Zagreb, City of Zagreb, 10000
Site 1550
- Recruiting
Poliklinika Bonifarm-Hondlova 2/11
Zagreb, City of Zagreb, 10000
Tanja Potocki Karacic, Site 1553, +38512446968
- Not yet recruiting
Local Institution - 1555
Zagreb, 10 090
Site 1555
Bulgaria5 sites, 5 recruiting
- Recruiting
Medical Center Medconsult Pleven OOD
Pleven, 5800
Mariya Alexandrova-Stoycheva, Site 1101, 360+11
- Recruiting
Outpatient Clinic for Individual Practice for Specialized Medical Care in Psychiatry - Dr. Madlena Dimitrova Borisova
Razgrad, 7200
Madlena Borisova, Site 1103, +359 88 991 2216
- Recruiting
Medical Center Sveti Naum EOOD
Sofia, 1113
Assen Karadaliev, Site 1100, 35929702117
- Not yet recruiting
Local Institution - 1104
Sofia, 1202
Site 1104
- Recruiting
Medical Center Mladost
Varna, 9020
Hristo Kozhuharov, Site 1102, 35952555695
Portugal5 sites, 5 recruiting
- Recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, 3049
Isabel Santana, Site 1401, 351239400448
- Recruiting
Centro Hospitalar do Alto Ave
Guimarães, 4835-044
Joana Meireles, Site 1402, 253540330
- Recruiting
Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035
Ana Verdelho, Site 1404, 3512178050x50
- Recruiting
Unidade Local de Saúde de Matosinhos SA
Senhora da Hora, 4464-513
Vitor Tedim Cruz, Site 1403, 3519123604x24
- Recruiting
Campus Neurologico Senior
Torres Vedras, 2560-280
Camila Nóbrega, Site 1400, +351261330700
Taiwan5 sites, 5 recruiting
- Recruiting
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung Niao Sung Dist, Kaohsiung, 83301
Chiung-Chih Chang, Site 1753
- Recruiting
National Cheng Kung University Hospital
Tainan, Taiana, 704
Ming-Chyi Pai, Site 1751
- Recruiting
National Taiwan University Hospital
Taipei, 100229
Yi-Ting Lin, Site 1754
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Jong-Ling Fuh, Site 1750
- Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Yi-chun Chen, Site 1752
About this study
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC in adult participants with agitation related to Alzheimer's Disease.
- Conditions
- Alzheimer Disease
- Being tested
- Xanomeline/Trospium Chloride Capsule, Xanomeline Enteric Capsule, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline/Trospium Chloride CapsuleDrug
Also called KarXT, BMS-986510
Specified dose on specified days
Xanomeline Enteric CapsuleDrug
Also called KarX-EC, BMS-986519
Specified dose on specified days
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| KarXT + KarX-EC | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride Capsule; Drug: Xanomeline Enteric Capsule |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on the Cohen-Mansfield Agitation Inventory-International Psychogeriatric Association (CMAI-IPA) Total Score at Week 14
Measured: At Week 14
Secondary outcomes (20)
Change from baseline on the Clinical Global Impressions-Severity (CGI-S) at Week 14
Measured: At Week 14
Change from baseline on the CMAI-IPA Domains at Week 14
Measured: At Week 14
Change from baseline on the CMAI Total Score at Week 14
Measured: At Week 14
Number of participants with Occurrence of Response at Week 14
As determined by CMAI-IPA Total Score changes of at least 30%, 40%, and 50% from baseline
Measured: At Week 14
Change from baseline on the Neuropsychiatric Inventory/Neuropsychiatric Inventory -Nursing Home (NPI/NPI-NH) Total Score at Week 14
Measured: At Week 14
Number of participants with Adverse Events (AEs)
Measured: Up to Week 18
Number of participants with Treatment Emergent AEs (TEAEs)
Measured: Up to Week 18
Number of participants with Serious AEs (SAEs)
Measured: Up to Week 18
Number of participants with AEs leading to study drug withdrawal
Measured: Up to Week 14
Number of deaths
Measured: Up to Week 18
Number of participants with AEs of Special Interest (AESIs)
Measured: Up to Week 18
Barnes Akathisia Rating Scale (BARS)
Measured: Up to Week 14
Abnormal Involuntary Movement Scale (AIMS)
Measured: Up to Week 14
Body Weight
Measured: Up to Week 14
Body Mass Index (BMI)
Measured: Up to Week 14
Number of participants with vital sign abnormalities
Measured: Up to Week 18
Number of participants with clinical laboratory abnormalities
Measured: Up to Week 14
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Measured: Up to Week 14
Number of participants with suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Week 18
Severity of benign prostatic hyperplasia in male participants as assessed by International Prostate Symptom Score (IPSS)
Measured: Up to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start10 Jul 2025
- Primary completion24 Nov 2028 (estimated)
- Study completion8 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011732
- Sponsor's protocol ID
- CN012-0023
- Other IDs
- 2025-520613-31, U1111-1316-5745, 2025
- Status last verified
- Oct 2026
- First submitted
- 2 Jun 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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