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A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Sponsor: Bristol-Myers Squibb
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 2)
Key Details
Gender
All
Age Range
60 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
586
Start Date
2025-07-21
Completion Date
2029-02-23
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Placebo
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
Local Institution - 0029
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
Local Institution - 0030
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
Local Institution - 0110
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
Local Institution - 0121
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, București, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, București, 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
Local Institution - 0111
Kippax, Leeds, 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
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom