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RECRUITING
NCT07011745
PHASE3

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease

Sponsor: Bristol-Myers Squibb

View on ClinicalTrials.gov

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 (ADAGIO-2)

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

426

Start Date

2025-07-16

Completion Date

2028-11-13

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

Xanomeline/Trospium Chloride Capsule

Specified dose on specified days

DRUG

Xanomeline Enteric Capsule

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Locations (143)

Chandler Clinical Trials, LLC

Chandler, Arizona, United States

Local Institution - 2631

Chandler, Arizona, United States

TrialSphere Corp

Chandler, Arizona, United States

National Institute of Clinical Research

Garden Grove, California, United States

Local Institution - 2607

Long Beach, California, United States

Accellacare

Long Beach, California, United States

Local Institution - 2627

Napa, California, United States

ATP Clinical Research

Orange, California, United States

Local Institution - 2613

Pasadena, California, United States

Local Institution - 2614

San Diego, California, United States

Local Institution - 2620

West Hills, California, United States

Local Institution - 2601

Basalt, Colorado, United States

Local Institution - 2632

Norwalk, Connecticut, United States

Visionary Investigators Network

Aventura, Florida, 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

Miami Jewish health

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

Local Institution - 2615

Worcester, Massachusetts, United States

Local Institution - 2618

Ann Arbor, Michigan, United States

Local Institution - 2630

Saint Paul, Minnesota, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Local Institution - 2603

Ozark, Missouri, United States

Las Vegas Clinical Trials

Las Vegas, Nevada, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Local Institution - 2647

Brooklyn, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

Walnut Clinical Research

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

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

Local Institution - 2612

Bountiful, Utah, United States

EvergreenHealth Medical Center

Kirkland, Washington, United States

Local Institution - 2610

Milwaukee, Wisconsin, United States

Centro Neurobiológico y de Estrés Traumático - CENydET S.R.L.

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Fundacion para el Estudio y Tratamiento de Enfermedades mentales- FETEM

Buenos Aires, Argentina

Hospital Italiano de Buenos Aires (HIBA)

Buenos Aires, Argentina

Instituto Modelo de Neurología, Fundación Lennox

Córdoba, Argentina

Sanatorio Morra S.A.

Córdoba, Argentina

Instituto Médico DAMIC

Córdoba, Argentina

Resolution Psychopharmacology Research Institute

Mendoza, Argentina

Biomedica Research Group

Santiago, Santiago Metropolitan, Chile

Local Institution - 2050

Santiago, Santiago Metropolitan, Chile

Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, Chile

Clinica Alemana

Vitacura, Santiago Metropolitan, Chile

Local Institution - 2055

Viña del Mar, Valparaiso, Chile

Psicomed Estudios Médicos Cía Ltda

Antofagasta, Chile

AGE Centrum

Olomouc, Olomouc Region, 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

Hopital Gui Chauliac - Chu Montpellier

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

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hajdú-Bihar, Hungary

Local Institution - 2256

Budapest, Hungary

Local Institution - 2251

Budapest, Hungary

Semmelweis Egyetem

Budapest, Hungary

Local Institution - 2255

Dunaújváros, Hungary

Local Institution - 2254

Gyöngyös, Hungary

The Chaim Sheba Medical Center

Ramat Gan, Central District, Israel

Local Institution - 2302

Petch Tikva, IL, 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

Local Institution - 2455

Katowice, Poland

Local Institution - 2458

Krakow, Poland

And 43 more locations on ClinicalTrials.gov