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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)
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.
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)
Key Details
Gender
All
Age Range
55 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
650
Start Date
2025-12-02
Completion Date
2029-07-20
Last Updated
2026-10-16
Healthy Volunteers
No
Conditions
Interventions
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Locations (252)
Local Institution - 2609
Chandler, Arizona, United States
Imaging Endpoints
Scottsdale, Arizona, United States
Local Institution - 1657
Anaheim, California, United States
Local Institution - 1668
Fresno, California, United States
Local Institution - 2625
Long Beach, California, United States
Local Institution - 2642
Long Beach, California, United States
Local Institution - 2649
Orange, California, United States
Local Institution - 2613
Pasadena, California, United States
Local Institution - 1662
Pomona, California, United States
Local Institution - 1639
Torrance, California, United States
Local Institution - 1651
Walnut Creek, California, United States
Local Institution - 2602
Bonita Springs, Florida, United States
Nuovida Research Center
Miami, Florida, United States
Local Institution - 1635
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
IPTB Clinical Research
Tampa, Florida, United States
Hope Research Network - Miami
Virginia Gardens, Florida, United States
Local Institution - 2611
Atlanta, Georgia, United States
Local Institution - 1636
Gaithersburg, Maryland, United States
Boston Center for Memory
Newton, Massachusetts, United States
Local Institution - 2615
Worcester, Massachusetts, United States
Local Institution - 1620
Troy, Michigan, United States
Local Institution - 2256
Saint Paul, Minnesota, United States
Local Institution - 2629
Hattiesburg, Mississippi, United States
Local Institution - 2628
Las Vegas, Nevada, United States
Redbird Research
Las Vegas, Nevada, United States
Local Institution - 1664
Princeton, New Jersey, United States
Local Institution - 1656
New Windsor, New York, United States
Local Institution - 2619
Staten Island, New York, United States
Local Institution - 1658
Woodmere, New York, United States
West Clinical Research
Morehead City, North Carolina, United States
Local Institution - 2617
Blue Ash, Ohio, United States
Local Institution - 1640
Tulsa, Oklahoma, United States
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, United States
Horizon Clinical Research Center - Houston
Cypress, Texas, United States
Advanced Neurology Epilepsy and Sleep Center
El Paso, Texas, United States
Local Institution - 2622
Mesquite, Texas, United States
Local Institution - 2623
San Antonio, Texas, United States
Local Institution - 2612
Bountiful, Utah, United States
Local Institution - 1646
Bennington, Vermont, United States
Local Institution - 1644
Seattle, Washington, United States
Local Institution - 2610
Milwaukee, Wisconsin, United States
Local Institution - 2005
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 1001
La Plata, Buenos Aires, Argentina
Local Institution - 1002
Mar del Plata, Buenos Aires, Argentina
Local Institution - 2006
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 1006
Rosario, Santa Fe Province, Argentina
Local Institution - 2004
Buenos Aires, Argentina
Local Institution - 1003
Buenos Aires, Argentina
Local Institution - 1004
Córdoba, Argentina
Local Institution - 2000
Córdoba, Argentina
Local Institution - 2002
Córdoba, Argentina
Local Institution - 1005
Córdoba, Argentina
Local Institution - 1000
Córdoba, Argentina
Local Institution - 2003
Córdoba, Argentina
Local Institution - 2001
Mendoza, 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
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 1057
Campinas, São Paulo, Brazil
Local Institution - 1050
Rio de Janeiro, Brazil
CPQuali Pesquisa Clínica
São Paulo, Brazil
Local Institution - 1056
São Paulo, Brazil
Local Institution - 1101
Pleven, Bulgaria
Local Institution - 1103
Razgrad, Bulgaria
Medical Center Sveti Naum EOOD
Sofia, Bulgaria
Local Institution - 1104
Sofia, Bulgaria
Local Institution - 1102
Varna, Bulgaria
Local Institution - 1153
Hamilton, Ontario, Canada
Local Institution - 1155
London, Ontario, Canada
Local Institution - 1151
Toronto, Ontario, Canada
Local Institution - 1154
Toronto, Ontario, Canada
Ontario Shores Centre For Mental Health Sciences
Whitby, Ontario, Canada
Local Institution - 2051
Santiago, Santiago Metropolitan, Chile
Local Institution - 2052
Santiago, Santiago Metropolitan, Chile
Local Institution - 2054
Vitacura, Santiago Metropolitan, Chile
Local Institution - 2055
Viña del Mar, Valparaiso, Chile
Local Institution - 2053
Antofagasta, Chile
Local Institution - 1805
Beijing, Beijing Municipality, China
Local Institution - 1810
Beijing, Beijing Municipality, China
Local Institution - 1815
Haidian District, Beijing Municipality, China
Local Institution - 1809
Guangzhou, Guangdong, China
Local Institution - 1818
Shenzhen, Guangdong, China
Local Institution - 1802
Guangzhou, Guangzhou Province, China
Local Institution - 1803
Changsha, Hunan, China
Nanjing Drum Tower hospital
Nanjing, Jiangsu, China
Local Institution - 1814
Tianjin, Tianjin Municipality, China
Local Institution - 1804
Hangzhou, Zhejiang, China
Local Institution - 1817
Hangzhou, Zhejiang, China
Local Institution - 1812
Kunming, China
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 - 1555
Zagreb, Croatia
Local Institution - 1550
Zagreb, Croatia
AGE Centrum
Olomouc, Olomouc Region, Czechia
Local Institution - 2100
Prague, Praha 6, Czechia