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RECRUITING

NCT07011732

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 (ADAGIO-1)

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

Key Details

Gender

All

Age Range

55 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

352

Start Date

2025-07-10

Completion Date

2028-12-08

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Alzheimer Disease

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

Inclusion Criteria \- 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. ii) 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. B. 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 5 to 22, inclusive, at Screening (Visit 1). * Have one identified caregiver who should have sufficient contact (approximately 10 hours a week or more) and is willing to: i) 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). * CGI-S ≥ 4, as related to agitation, at Screening (Visit 1) and Baseline (Visit 2). * At least 1 of the following 3 criteria must be established from the CMAI-IPA at Screening (Visit 1) and Baseline (Visit 2; CMAI-IPA Physical/Verbal Aggression Positivity): i) 1 or more aggressive behaviors occurring at least several times per week. ii) 2 or more aggressive behaviors occurring at least once or twice per week. iii) 3 or more aggressive behaviors occurring less than once per week. Exclusion Criteria \- Medical Conditions: i) Agitation symptoms that are primarily attributable to a condition other than the AD causing the dementia. ii) 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. iv) 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). A. 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. B. Mirtazapine or trazodone may be used as a hypnotic if started at least 8 weeks prior to Screening (Visit 1). \- Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (157)

Imaging Endpoints

Scottsdale, Arizona, United States

Advanced Research Center (ARC) - Anaheim

Anaheim, California, United States

Kaizen Brain Center

La Jolla, California, United States

The Neurology Group

Pomona, California, United States

Torrance Clinical Research

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

Local Institution - 1602

Miami, Florida, United States

Local Institution - 1618

Miami, Florida, United States

Hope Research Network - Miami

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

Local Institution - 1661

Savannah, Georgia, 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

Local Institution - 1660

Springfield, Massachusetts, United States

Local Institution - 1665

Bloomfield Hills, Michigan, United States

Oakland Medical Research

Troy, Michigan, United States

Redbird Research

Las Vegas, Nevada, United States

Patient First MD

Middletown, New Jersey, United States

Local Institution - 1664

Princeton, New Jersey, United States

Local Institution - 1610

Inwood, New York, United States

Mid Hudson Medical Research

New Windsor, New York, United States

Local Institution - 1645

Woodmere, New York, United States

Local Institution - 1658

Woodmere, New York, United States

Local Institution - 1659

Centerville, Ohio, United States

Central States Research

Tulsa, Oklahoma, United States

Local Institution - 1652

Columbia, South Carolina, United States

Local Institution - 1653

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

Kingfisher Cooperative

Spokane, Washington, United States

Local Institution - 1001

La Plata, Buenos Aires, Argentina

Local Institution - 1002

Mar del Plata, Buenos Aires, Argentina

Local Institution - 1006

Rosario, Santa Fe Province, Argentina

Local Institution - 1003

Buenos Aires, Argentina

Local Institution - 1004

Córdoba, Argentina

Instituto Privado Kremer

Córdoba, Argentina

Local Institution - 1000

Córdoba, Argentina

Local Institution - 1051

Brasília, Federal District, Brazil

CECPAR - Centro de Estudos Clínicos do Paraná

Curitiba, Paraná, Brazil

PUCTrials

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

Ruschel Medicina e Pesquisa Clínica

Rio de Janeiro, Brazil

CPQuali Pesquisa Clínica

São Paulo, Brazil

Local Institution - 1056

São Paulo, Brazil

Medical Center Sveti Naum EOOD

Sofia, Sofia-Grad, Bulgaria

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 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

Local Institution - 1154

Toronto, Ontario, Canada

Ontario Shores Centre For Mental Health Sciences

Whitby, Ontario, Canada

Local Institution - 1150

Montreal, Quebec, Canada

Local Institution - 1805

Beijing, Beijing Municipality, China

Local Institution - 1810

Beijing, Beijing Municipality, China

Local Institution - 1815

Haidian District, Beijing Municipality, China

Local Institution - 1813

Chongqing, Chongqing Municipality, China

Local Institution - 1809

Guangzhou, Guangdong, China

Local Institution - 1802

Guangzhou, Guangdong, China

Local Institution - 1818

Shenzhen, Guangdong, China

Local Institution - 1803

Changsha, Hunan, China

Local Institution - 1801

Nanjing, Jiangsu, China

Local Institution - 1800

Shanghai, Shanghai Municipality, China

Local Institution - 1816

Xian, Shanxi, China

Local Institution - 1819

Chengdu, Sichuan, China

Local Institution - 1814

Tianjin, Tianjin Municipality, China

Local Institution - 1804

Hangzhou, Zhejiang, China

Local Institution - 1817

Hangzhou, China

Local Institution - 1812

Kunming, China

Local Institution - 1808

Tianjin, China

Local Institution - 1550

Zagreb, City of Zagreb, Croatia

Local Institution - 1553

Zagreb, City of Zagreb, Croatia

Local Institution - 1554

Rijeka, Croatia

Clinical Hospital Center Split

Split, Croatia

General Hospital Varazdin

Varaždin, 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

Local Institution - 1207

Athens, Greece

Local Institution - 1201

Ioannina, Greece

Euromedica General Clinic of Thessaloniki

Thessaloniki, Greece

Local Institution - 1251

Hyderabad, Andhra Pradesh, India

Local Institution - 1255

Ahmedabad, Gujarat, India

Local Institution - 1252

Hyderabad, Telangana, India

Local Institution - 1254

Varanasi, Uttar Pradesh, India

Local Institution - 1250

Kolkata, West Bengal, India

Local Institution - 1256

Delhi, India

Local Institution - 1253

New Delhi, India

Local Institution - 1301

Hadano, Kanagawa, Japan

Teikyo University Mizonokuchi Hospital

Kawasaki, Kanagawa, Japan

Local Institution - 1304

Sakai, Osaka, Japan

National Hospital Organization Hizen Psychiatric Center

Kanzaki-Gun Yoshinogari-Cho, Saga-ken, Japan

Rainbow and Sea Hospital

Karatsu-shi, Saga-ken, Japan

Local Institution - 1305

Bunkyo-ku, Tokyo, Japan

Kuramitsu Hospital

Fukuoka, Japan

Okayama City General Medical Center Okayama City Hospital

Okayama, Japan

Local Institution - 1308

Shimotsuke-shi, Tochigi, Japan

Hospital Universitario de Saltillo

Saltillo, Coahuila, Mexico

Boca Clinical Trials Mexico S.C.

Guadalajara, Jalisco, Mexico

Local Institution - 1363

Mexico City, Mexico City, Mexico

Local Institution - 1360

Mexico City, Mexico City, Mexico

Local Institution - 1364

Monterrey, Nuevo León, Mexico

Local Institution - 1350

Monterrey, Nuevo León, Mexico

Local Institution - 1361

Mexico City, Mexico

Neurociencias PRISMA A.C.

San Luis Potosí City, Mexico

Clinical Research Institute S.C.

Tlalnepantla, Mexico

Local Institution - 1401

Coimbra, Portugal

Centro Hospitalar do Alto Ave

Guimarães, Portugal

Local Institution - 1404

Lisbon, Portugal

Unidade Local de Saúde de Matosinhos SA

Senhora da Hora, Portugal

Campus Neurologico Senior

Torres Vedras, Portugal

Local Institution - 1450

Bucharest, București, Romania

Local Institution - 1454

Bucharest, București, Romania