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RECRUITING

NCT06976216

PHASE3

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in 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 for cognitive impairment in Alzheimer's Disease

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for the Treatment of Cognitive Impairment Associated With Mild to Moderate Alzheimer's Disease (MINDSET 1)

Key Details

Gender

All

Age Range

60 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

586

Start Date

2025-07-14

Completion Date

2029-02-23

Last Updated

2026-03-25

Healthy Volunteers

Conditions

Alzheimer's Disease

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

KarX-EC

Specified dose on specified days

OTHER

Placebo

Specified dose on specified days

Inclusion Criteria * Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach. * Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening. * Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities. * Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration. Exclusion Criteria * Participants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the study results. This includes any grade of hepatic impairment, urinary retention, active biliary disease, moderate-severe renal impairment (eGFR of \<50 mL/min), and unstable hypertension or tachycardia. * Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion. * Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening. * Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that reflect significant pathology other than AD or could affect safety or interfere with study procedures. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (109)

Healthy Brain Clinic

Long Beach, California, United States

Anderson Clinical Research

Redlands, California, United States

Mountain Neurological Research Center

Basalt, Colorado, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

JEM Research Institute

Atlantis, Florida, United States

VIN-Julie Schwartzbard

Aventura, Florida, United States

Merritt Island Medical Research, LLC

Merritt Island, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Alzheimer's Research and Treatment Center

Stuart, Florida, United States

Charter Research - Lady Lake

The Villages, Florida, United States

Local Institution - 0016

Columbus, Georgia, United States

Center for Advanced Research & Education

Gainesville, Georgia, United States

Re:Cognition Health - Chicago

Chicago, Illinois, United States

Ascension Alexian Brothers

Elk Grove Village, Illinois, United States

Boston Center for Memory

Newton, Massachusetts, United States

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States

Advanced Memory Research Institute of New Jersey

Toms River, New Jersey, United States

NYU Langone Health

New York, New York, United States

Local Institution - 0259

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

AMC Research, LLC

Matthews, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Neurology Diagnostics, Inc.

Dayton, Ohio, United States

Summit Headlands

Portland, Oregon, United States

Local Institution - 0004

Abington, Pennsylvania, United States

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Gadolin Research

Beaumont, Texas, United States

Local Institution - 0088

Banfield, Buenos Aires, Argentina

Local Institution - 0001

Buenos Aires, Buenos Aires F.D., Argentina

Local Institution - 0271

Buenos Aires, Argentina

Fundación Lennox - Instituto Modelo de Neurología

Córdoba, Argentina

Sanatorio Morra S.A.

Córdoba, Argentina

Instituto Kremer

Córdoba, Argentina

Southern Neurology

Kogarah, New South Wales, Australia

KARA Institute for Neurological Diseases

Macquarie Park, New South Wales, Australia

NeuroCentrix

Carlton, Victoria, Australia

Neurodegenerative Disorders Research

Perth, Western Australia, Australia

St Vincent's Hospital Sydney Limited

Darlinghurst, Australia

Local Institution - 0168

Brasília, Federal District, Brazil

Local Institution - 0180

Curitiba, Paraná, Brazil

Local Institution - 0266

Aracaju, Sergipe, Brazil

Hospital das Clinicas FMUSP

São Paulo, Brazil

OCT Research ULC

Kelowna, British Columbia, Canada

Richmond Clinical Trials

Richmond, British Columbia, Canada

Centricity Research Halifax Multispecialty

Halifax, Nova Scotia, Canada

Ottawa Memory Clinic

Ottawa, Ontario, Canada

Toronto Memory Program

Toronto, Ontario, Canada

MoCA Research and Innovation Inc.

Greenfield Park, Quebec, Canada

Diex Recherche Victoriaville

Victoriaville, Quebec, Canada

ALPHA Recherche Clinique

Québec, Canada

Local Institution - 0230

Antofagasta, AN, Chile

Local Institution - 0094

Santiago, Santiago Metropolitan, Chile

Local Institution - 0089

Santiago, Santiago Metropolitan, Chile

Local Institution - 0241

Santiago, Santiago Metropolitan, Chile

Local Institution - 0215

Zagreb, City of Zagreb, Croatia

Poliklinika Neuron

Zagreb, City of Zagreb, Croatia

Local Institution - 0216

Osijek, Croatia

Local Institution - 0267

Rijeka, Croatia

Local Institution - 0240

Zagreb, Croatia

Neuro Health Centrum

Brno, Brno-město, Czechia

AGE Centrum

Olomouc, Olomoucký kraj, Czechia

A-Shine

Pilsen, Plzeň-město, Czechia

Neurologická Ambulance - Forbeli

Prague, Praha 6, Czechia

Neuropsychiatrie

Prague, Praha 6, Czechia

Institut neuropsychiatricke pece (INEP), Praha

Prague, Praha 8, Czechia

Vestra Clinics

Rychnov nad Kněžnou, Czechia

Local Institution - 0219

Münster, North Rhine-Westphalia, Germany

Local Institution - 0276

Mainz, Rhineland-Palatinate, Germany

Local Institution - 0218

Berlin, Germany

Local Institution - 0277

Bremen, Germany

Local Institution - 0275

Hamburg, Germany

TUM Klinikum

Munich, Germany

University General Hospital of Alexandroupoli

Alexandroupoli, Anatolikí Makedonía Kai Thráki, Greece

Local Institution - 0256

Athens, Attikí, Greece

Aiginiteio University Hospital

Athens, Attikí, Greece

Local Institution - 0257

Larissa, Thessalía, Greece

Local Institution - 0288

Bengaluru, Karnataka, India

Local Institution - 0282

Hyderabad, Telangana, India

Local Institution - 0285

Hyderabad, Telangana, India

Local Institution - 0287

Varanasi, Uttar Pradesh, India

Local Institution - 0286

Kolkata, West Bengal, India

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy, Italy

Ospedale San Raffaele

Milan, Lombardy, Italy

Local Institution - 0248

Monza, Lombardy, Italy

Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Italy

Local Institution - 0262

Poznan, Greater Poland Voivodeship, Poland

Local Institution - 0261

Torun, Kuyavian-Pomeranian Voivodeship, Poland

MlynowaMed Psychiatric

Bialystok, Podlaskie Voivodeship, Poland

Centrum Badan Klinicznych PI-House sp. z o.o.

Gdansk, Pomeranian Voivodeship, Poland

Local Institution - 0181

San Juan, Puerto Rico

Local Institution - 0278

Bucharest, București, Romania

Local Institution - 0273

Bucharest, București, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, București, Romania

Local Institution - 0268

Iași, Romania

Chonnam National University Hospital

Gwangju, Kwangju-Kwangyǒkshi, South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Seoul National University Hospital