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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)
Sponsor: Bristol-Myers Squibb
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.
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
Key Details
Gender
All
Age Range
55 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
426
Start Date
2025-07-10
Completion Date
2028-12-08
Last Updated
2026-10-15
Healthy Volunteers
No
Conditions
Interventions
Xanomeline/Trospium Chloride Capsule
Specified dose on specified days
Xanomeline Enteric Capsule
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (162)
Imaging Endpoints
Scottsdale, Arizona, United States
Advanced Research Center (ARC) - Anaheim
Anaheim, California, United States
Local Institution - 1668
Fresno, California, United States
Local Institution - 1637
La Jolla, California, United States
The Neurology Group
Pomona, California, United States
Local Institution - 1639
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
Flourish Research
Merritt Island, Florida, United States
Local Institution - 1602
Miami, Florida, United States
Local Institution - 1618
Miami, Florida, United States
Local Institution - 1604
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
Hope Research Network - Miami
Virginia Gardens, Florida, 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
Voltaire Springfield
Springfield, Massachusetts, United States
NeuroBehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Oakland Medical Research
Troy, Michigan, United States
Local Institution - 1667
St Louis, Missouri, United States
Redbird Research
Las Vegas, Nevada, United States
Local Institution - 1647
Middletown, New Jersey, United States
Global Medical Institutes LLC; Princeton Medical Institute
Princeton, New Jersey, United States
Local Institution - 1610
Inwood, New York, United States
Mid Hudson Medical Research
New Windsor, New York, United States
Five Towns Neurology PC -Woodmere - 923 Broadway
Woodmere, New York, United States
Local Institution - 1645
Woodmere, New York, United States
Central States Research
Tulsa, Oklahoma, United States
Local Institution - 1652
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
The Memory Clinic
Bennington, Vermont, United States
Local Institution - 1644
Seattle, Washington, United States
Local Institution - 1654
Spokane, Washington, United States
Local Institution - 1001
La Plata, Buenos Aires, Argentina
Local Institution - 1002
Mar del Plata, Buenos Aires, Argentina
CEN Centro Especializado en Neurociencias
Córdoba, Córdoba Province, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
Buenos Aires, Argentina
Instituto Privado Kremer
Córdoba, Argentina
Centro Medico Luquez
Córdoba, Argentina
L2IP - Instituto de Pesquisas Clínicas
Brasília, Federal District, Brazil
CECPAR - Centro de Estudos Clínicos do Paraná
Curitiba, Paraná, Brazil
PUCTrials
Curitiba, Paraná, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, Brazil
CPQuali Pesquisa Clínica
São Paulo, Brazil
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, Brazil
Medical Center Medconsult Pleven OOD
Pleven, Bulgaria
Outpatient Clinic for Individual Practice for Specialized Medical Care in Psychiatry - Dr. Madlena Dimitrova Borisova
Razgrad, Bulgaria
Medical Center Sveti Naum EOOD
Sofia, Bulgaria
Local Institution - 1104
Sofia, Bulgaria
Medical Center Mladost
Varna, Bulgaria
Local Institution - 1153
Hamilton, Ontario, Canada
Local Institution - 1755
London, Ontario, Canada
London Health Sciences Centre-Victoria Campus
London, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Centre for Addiction & Mental Health
Toronto, Ontario, Canada
Ontario Shores Centre For Mental Health Sciences
Whitby, Ontario, Canada
Local Institution - 1150
Montreal, Quebec, Canada
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking University Sixth Hospital
Haidian District, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Affiliated Brain Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shenzhen Kangning Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangzhou Province, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Nanjing Drum Tower hospital
Nanjing, Jiangsu, China
Local Institution - 1800
Shanghai, Shanghai Municipality, China
Local Institution - 1811
Shanghai, Shanghai Municipality, China
Mental Health Center of Xi'an City
Xian, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, China
The First Affiliated Hospital of Kunming Medical University
Kunming, China
Local Institution - 1808
Tianjin, China
Local Institution - 1550
Zagreb, City of Zagreb, Croatia
Poliklinika Bonifarm-Hondlova 2/11
Zagreb, City of Zagreb, Croatia
Klinicki Bolnicki Centar Rijeka
Rijeka, Croatia
Clinical Hospital Center Split
Split, Croatia
General Hospital Varazdin
Varaždin, Croatia
Local Institution - 1555
Zagreb, Croatia
University Hospital of Patras
Pátrai, Achaḯa, Greece
Henry Dunant Hospital Center
Athens, Attica, Greece
Aiginiteio University Hospital
Athens, Attikí, Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí, Greece
Eginition Hospital
Athens, Greece
Athens Medical Center
Athens, Greece
Local Institution - 1201
Ioannina, Greece