RecruitingPhase 3NCT06976203

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)

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 2)


Sponsor

Bristol-Myers Squibb

Enrollment

586 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

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 whether KarXT — a new medication that works differently from existing Alzheimer's drugs by targeting specific receptors in the brain — can improve memory and thinking in people with mild to moderate Alzheimer's disease. **You may be eligible if...** - You have a confirmed diagnosis of Alzheimer's disease at the mild or moderate stage - Your Alzheimer's pathology has been confirmed using the latest diagnostic guidelines (including biomarkers) - Your score on the Mini-Mental State Examination (MMSE) is between 12 and 22 - You have a caregiver who spends at least 10 hours per week with you and can attend all study visits **You may NOT be eligible if...** - Your cognitive decline is caused by a condition other than Alzheimer's (e.g., vascular dementia, Lewy body disease) - You have serious psychiatric illness, uncontrolled medical conditions, or certain heart problems - You are unable to tolerate the study medication based on prior reactions 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGKarXT

Specified dose on specified days

DRUGKarX-EC

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days


Locations(123)

Fullerton Neurology and Headache Center

Fullerton, California, United States

Inglewood Clinical

Inglewood, California, United States

Irvine Clinical Research

Irvine, California, United States

Local Institution - 0083

Palo Alto, California, United States

Local Institution - 0069

San Diego, California, United States

Research of the Rockies

Colorado Springs, Colorado, United States

Neuropsychiatric Research Center of Southwest Florida

Fort Myers, Florida, United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

K2 MEDICAL Research THE VILLAGES

Lady Lake, Florida, United States

Intercoastal Medical Group

Sarasota, Florida, United States

USF Health Byrd Alzheimer's Institute

Tampa, Florida, United States

Alzheimer's Research and Treatment Center

Wellington, Florida, United States

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Josephson Wallack Munshower Neurology, PC

Indianapolis, Indiana, United States

Local Institution - 0080

Watertown, Massachusetts, United States

QUEST Research Institute

Farmington Hills, Michigan, United States

Private Practice - Dr. Ronald Louis Schwartz

Hattiesburg, Mississippi, United States

Local Institution - 0119

Ridgewood, New Jersey, United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey, United States

Advanced Clinical Institute

West Long Branch, New Jersey, United States

Neurological Associates Albany

Albany, New York, United States

Dent Neurosciences Research Center, Inc

Amherst, New York, United States

University at Buffalo - UBMD Neurology

Buffalo, New York, United States

Local Institution - 0078

Lake Success, New York, United States

Keystone Clinical Studies

Plymouth Meeting, Pennsylvania, United States

Local Institution - 0081

Dallas, Texas, United States

Central Texas Neurology Consultants, PA

Round Rock, Texas, United States

Rainier Clinical Research Center

Renton, Washington, United States

Hospital Italiano de Buenos Aires

ABB, Buenos Aires F.D., Argentina

Centro Médico Luquez

Córdoba, Córdoba Province, Argentina

Local Institution - 0025

Buenos Aires, Argentina

CEN Centro Especializado en Neurociencias

Córdoba, Argentina

Instituto Médico DAMIC

Córdoba, Argentina

Resolution Psychopharmacology Research Institute

Mendoza, Argentina

USC Clinical Trials Sunshine Coast

Birtinya, Queensland, Australia

Local Institution - 0055

Saint Lucia, Queensland, Australia

Griffith University - Gold Coast Campus

Southport, Queensland, Australia

Austin Health

Ivanhoe, Victoria, Australia

Local Institution - 0115

Fortaleza, Ceará, Brazil

Local Institution - 0101

Maringá, Paraná, Brazil

Local Institution - 0099

Rio de Janeiro, Brazil

Local Institution - 0100

São Paulo, Brazil

Terveystalo Oulu

Oulu, North Ostrobothnia, Finland

Clinical Research Services Turku

Turku, Southwest Finland, Finland

CRST Helsinki Oy

Helsinki, Uusimaa, Finland

Terveystalo Ruoholahti

Helsinki, Finland

Itä-Suomen Yliopisto Kuopio

Kuopio, Finland

Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone

Marseille, Bouches-du-Rhône, France

Centre Hospitalier Universitaire Toulouse - Cité de la Santé

Toulouse, Haute-Garonne, France

Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro

Lille, Hauts-de-France, France

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou

Rennes, Ille-et-Vilaine, France

Centre Hospitalier Universitaire Régional de Nancy

Nancy, Meurthe-et-Moselle, France

Hospices Civils de Lyon - Hôpital Pierre Wertheimer

Bron, Rhône, France

Local Institution - 0017

Villefranche-sur-Saône, Rhône, France

Bordeaux University Hospital - Pellegrin

Bordeaux, France

Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière

Paris, France

Hôpital Broca

Paris, France

Pitie Salpetriere University Hospital

Paris, France

Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau

Strasbourg, France

Local Institution - 0004

Munich, Bavaria, Germany

Universitätsmedizin Göttingen - Georg-August-Universität

Göttingen, Lower Saxony, Germany

Private Practice - Dr. Irma Schöll

Bad Homburg, Germany

Pharmakologisches Studienzentrum Chemnitz

Chemnitz, Germany

Universitaetsklinikum Koeln

Cologne, Germany

Universitaetsklinikum Ulm

Ulm, Germany

University Hospital of Patras

Pátrai, Achaḯa, Greece

University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"

Chaïdári, Attikí, Greece

Hygeia Hospital

Marousi, Attikí, Greece

Local Institution - 0059

Ioannina, Ioánnina, Greece

AHEPA University General Hospital of Thessaloniki

Thessaloniki, Greece

University of Naples Federico II

Naples, Campania, Italy

Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia

Foggia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Roma, Italy

Inage Neurology and Memory Clinic

Inage, Chiba, Japan

Local Institution - 0123

Matsudo, Chiba, Japan

Local Institution - 0124

Higashihiroshima, Hiroshima, Japan

Local Institution - 0120

Kita, Kagawa-ken, Japan

Local Institution - 0125

Kamakura, Kanagawa, Japan

Kokankai Kokan Clinic

Kawasaki, Kanagawa, Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasaki, Kanagawa, Japan

Local Institution - 0038

Ina, Nagano, Japan

National Hospital Organization Niigata Hospital

Kashiwazaki, Niigata, Japan

Katayama Medical Clinic

Kurashiki, Okayama-ken, Japan

Tominaga Clinic

Osaka, Osaka, Japan

National Hospital Organization Hizen Psychiatric Center

Yoshinogari-cho, Kanzaki-gun, Saga-ken, Japan

Local Institution - 0037

Wako, Saitama, Japan

Wako Hospital

Wako, Saitama, Japan

Local Institution - 0107

Kyoto, Japan

Brain Research Center Den Bosch B.V.

's-Hertogenbosch, North Brabant, Netherlands

Brain Research Center

Amsterdam, North Holland, Netherlands

Brain Research Center Zwolle

Zwolle, Overijssel, Netherlands

Instytut Zdrowia Dr Boczarska Jedynak

Oświęcim, Lesser Poland Voivodeship, Poland

Penta Hospitals Przychodnie, Wrocław Wejherowska

Wroclaw, Lower Silesian Voivodeship, Poland

Local Institution - 0108

Lublin, Lublin Voivodeship, Poland

EMC Silesia sp. z o.o.

Katowice, Silesian Voivodeship, Poland

Campus Neurológico Sénior

Torres Vedras, Lisbon District, Portugal

Unidade Local de Saude de Matosinhos

Matosinhos Municipality, Porto District, Portugal

Hospital de Braga

Braga, Portugal

Local Institution - 0049

Coimbra, Portugal

Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira

Guimarães, Portugal

Local Institution - 0052

Porto, Portugal

SCB Research Center

Bayamón, Puerto Rico

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Prof. Dr. Alexandru Obregia Psychiatry Hospital

Bucharest, Bucharest, Romania

Local Institution - 0113

Constanța, Constanța County, Romania

Local Institution - 0042

Bucharest, Romania

Local Institution - 0041

Sanpetru /Brasov, Romania

Fundació ACE

Barcelona, Barcelona [Barcelona], Spain

Policlinica Gipuzkoa

Donostia / San Sebastian, Basque Country, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Universitario Doctor Peset

Valencia, Valenciana, Comunitat, Spain

Complejo Hospitalario Ruber Juan Bravo

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

NIHR Manchester Clinical Research Facility

Manchester, England, United Kingdom

The Maudsley Hospital

London, London, City of, United Kingdom

Local Institution - 0103

Edinburgh, Midlothian, United Kingdom

Warneford Hospital

Oxford, Oxfordshire, United Kingdom

Re:Cognition Health - Birmingham

Birmingham, United Kingdom

Local Institution - 0111

Leeds, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06976203


Related Trials