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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-2)
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
352
Start Date
2025-07-16
Completion Date
2028-11-13
Last Updated
2026-04-01
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 (140)
Chandler Clinical Trials, LLC
Chandler, Arizona, United States
Local Institution - 2631
Chandler, Arizona, United States
Local Institution - 2625
Long Beach, California, United States
Local Institution - 2607
Long Beach, California, United States
Accellacare
Long Beach, California, United States
Local Institution - 2627
Napa, California, United States
Local Institution - 2613
Pasadena, California, United States
Local Institution - 2614
San Diego, California, United States
Alliance Clinical -West Hills
West Hills, California, United States
Local Institution - 2601
Basalt, Colorado, United States
Local Institution - 2635
Colorado Springs, Colorado, United States
Local Institution - 2632
Norwalk, Connecticut, United States
Envision Trials LLC
Bonita Springs, Florida, United States
Key Clinical Research
Bradenton, Florida, United States
Local Institution - 2636
Doral, Florida, United States
Local Institution - 2606
Homestead, Florida, United States
Local Institution - 2633
Miami, Florida, United States
Local Institution - 2637
Miami, Florida, United States
Local Institution - 2634
Orlando, Florida, United States
IPTB Clinical Research
Tampa, Florida, United States
Agile Clinical Research Trials, LLC
Atlanta, Georgia, United States
Vitalix Clinical
Worcester, Massachusetts, United States
Michigan Clinical Research Institute PC
Ann Arbor, Michigan, United States
Local Institution - 2630
Saint Paul, Minnesota, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Sharlin Health Neuroscience Research Center
Ozark, Missouri, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Local Institution - 2644
Valley Stream, New York, United States
West Clinical Research
Morehead City, North Carolina, United States
Velocity Clinical Research - Blue Ash
Blue Ash, Ohio, United States
Local Institution - 2643
Canton, Ohio, United States
Epic Medical Research, LLC - Carrolton
Carrollton, Texas, United States
Horizon Clinical Research Center - Houston
Cypress, Texas, United States
Epic Medical Research, LLC - Mesquite
Mesquite, Texas, United States
UT Health - San Antonio
San Antonio, Texas, United States
Pantheon Clinical Research, LLC
Bountiful, Utah, United States
Local Institution - 2638
Kirkland, Washington, United States
Local Institution - 2610
Milwaukee, Wisconsin, United States
Local Institution - 2005
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 2006
Buenos Aires, Buenos Aires F.D., Argentina
Local Institution - 2004
Buenos Aires, Argentina
Local Institution - 2000
Córdoba, Argentina
Local Institution - 2002
Córdoba, Argentina
Local Institution - 2003
Córdoba, Argentina
Local Institution - 2001
Mendoza, Argentina
Local Institution - 2055
Viña del Mar, Región de Valparaíso, Chile
Local Institution - 2051
Santiago, Santiago Metropolitan, Chile
Local Institution - 2050
Santiago, Santiago Metropolitan, Chile
Local Institution - 2052
Santiago, Santiago Metropolitan, Chile
Local Institution - 2054
Vitacura, Santiago Metropolitan, Chile
Local Institution - 2053
Antofagasta, Chile
AGE Centrum
Olomouc, Olomoucký kraj, Czechia
Neuropsychiatrie
Prague, Praha 6, Czechia
Institut neuropsychiatricke pece (INEP), Praha
Prague, Praha 8, Czechia
Neuro Health Centrum s.r.o.
Brno, South Moravian, Czechia
NEUROHK
Choceň, Czechia
A-SHINE s.r.o.
Pilsen, Czechia
Local Institution - 2102
Prague, Czechia
Local Institution - 2105
Prague, Czechia
Vestra Clinics s.r.o.
Rychnov nad Kněžnou, Czechia
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne, France
Hôpital des Charpennes - Hospices Civils de Lyon (HCL)
Villeurbanne, Rhône, France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges, France
Local Institution - 2157
Montpellier, France
Centres Memoire de Ressources et de Recherche (CMRR) - Hopital Lariboisiere-Fernand-Widal Location
Paris, France
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
Strasbourg, France
Local Institution - 2201
Düsseldorf, Germany
Local Institution - 2205
Halle, Germany
Local Institution - 2206
Westerstede, Germany
Local Institution - 2257
Kalocsa, Bács-Kiskun county, Hungary
Local Institution - 2250
Győr, Győr-Moson-Sopron, Hungary
Local Institution - 2254
Gyöngyös, Heves County, Hungary
Local Institution - 2256
Budapest, Hungary
Local Institution - 2255
Budapest, Hungary
Local Institution - 2251
Budapest, Hungary
Local Institution - 2253
Budapest, Hungary
Local Institution - 2252
Debrecen, Hungary
The Chaim Sheba Medical Center
Ramat Gan, Central District, Israel
Local Institution - 2302
Petch Tikva, IL, Israel
Local Institution - 2301
Jerusalem, Israel
Sanz MC, Laniado Hospital
Netanya, Israel
The Israeli Alzheimer Medical Center
Ramat Gan, Israel
Bayit Balev Ltd.
Rishon Le'Tzion, Israel
University of Naples Federico II
Naples, Campania, Italy
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Viale del Policlinico 155
Rome, Lazio, Italy
Azienda Ospedaliero-Universitaria Sant'Andrea
Rome, Lazio, Italy
Auxologico IRCCS - Auxologico San Luca
Milan, Lombardy, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, PI, Italy
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, Italy
Local Institution - 2355
Isernia, Italy
Fondazione Policlinico Gemelli IRCCS
Roma, Italy
Centrum Medyczne HCP Szpital im. Jana Pawla II
Poznan, Greater Poland Voivodeship, Poland
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
M2M Med
Chorzów, Poland
Centrum In Psyche Spersonalizowanej Psychiatrii I Terapii
Katowice, Poland
Local Institution - 2451
Lublin, Poland
Local Institution - 2452
Lublin, Poland
RCMed Oddzial Sochaczew
Sochaczew, Poland
Local Institution - 2641
San Juan, Puerto Rico
Local Institution - 2640
San Juan, Puerto Rico
Local Institution - 2639
San Juan, Puerto Rico
Local Institution - 2645
San Juan, Puerto Rico
Inha University Hospital
Incheon, Incheon Gwang'yeogsi, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Konkuk University Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 2406
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
SMG-SNU Borame Medical Center
Seoul, South Korea
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, South Korea
CNCE "Cherkasy regional psychiatric hospital of Cherkasy regional council"
Smila, Cherkasy Oblast, Ukraine
Local Institution - 2554
Dnipro, Dnipropetrovsk Oblast, Ukraine
Local Institution - 2566
Hlevakha, Kyiv Oblast, Ukraine
Local Institution - 2552
Lviv, Lviv Oblast, Ukraine
Local Institution - 2569
Lviv, Lviv Oblast, Ukraine
Local Institution - 2567
Oleksandrivka, Odesa Oblast, Ukraine
CNPE "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. Acad. O.I. Yushchenko of Vinnytsia Regional Counsil"
Vinnytsia, Vinnytsia Oblast, Ukraine
Local Institution - 2560
Lutsk, Volyn Oblast, Ukraine
Local Institution - 2556
Hlevakha, Ukraine
Local Institution - 2550
Kropyvnytskyi, Ukraine
Local Institution - 2565
Kyiv, Ukraine
Local Institution - 2553
Kyiv, Ukraine
"Medical Centre "Neuroclinic" LLC
Lviv, Ukraine
Local Institution - 2568
Odesa, Ukraine
Local Institution - 2557
Poltava, Ukraine
Local Institution - 2559
Skarzhyntsi, Ukraine
Lancashire & South Cumbria NHS Foundation Trust
Preston, Lancashire, United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, Surrey, United Kingdom
Local Institution - 2502
Cambridge, United Kingdom
South London and Maudsley NHS Foundation Trust
London, United Kingdom
Local Institution - 2500
London, United Kingdom
NeuroClin Glasgow
Motherwell, United Kingdom
Cornwall Partnership NHS Foundation Trust
Redruth, United Kingdom
Sheffield Health and Social care NHS Foundation Trust
Sheffield, United Kingdom
Local Institution - 2509
Stafford, United Kingdom
Local Institution - 2503
Wolverhampton, United Kingdom