RecruitingPhase 3NCT06976216

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

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)

Sponsor

Bristol-Myers Squibb

Enrollment

586 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer s Disease

Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease

Eligibility

Min Age: 60 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing KarXT — a new oral medication that targets specific brain receptors — to see if it improves memory and thinking in people with mild to moderate Alzheimer's disease, in a separate study that mirrors a companion trial. **You may be eligible if...** - You have a confirmed Alzheimer's disease diagnosis at the mild or moderate stage, confirmed with biomarker testing - Your MMSE score is between 12 and 22 - You have a caregiver who is in regular contact (at least 10 hours per week) and can attend all visits **You may NOT be eligible if...** - Your cognitive symptoms are caused by something other than Alzheimer's disease - You have serious heart, liver, or psychiatric conditions - You are unable to participate fully due to physical or mental health reasons - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKarXT

Specified dose on specified days

DRUGKarX-EC

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

Locations(106)

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

NDx Clinical Research 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 - 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

Instituto de Neurologia de Curitiba

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

Klinika za psihijatriju "Vrapče"

Zagreb, Croatia

Neuro Health Centrum

Brno, Brno-město, Czechia

AGE Centrum

Olomouc, Olomouc Region, 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

Osrodek Badan Klinicznych CLINSANTE S.C.

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 - 0273

Bucharest, Bucharest, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Institutul Național de Gerontologie și Geriatrie "Ana Aslan"

Bucharest, 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