A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Start Date
7/21/2025
Completion Date
2/23/2029
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 Criteria
Age Range: 60 years to 85 years
Interventions
KarXT
KarX-EC
Placebo
Conditions
Locations
Fullerton Neurology and Headache Center
Fullerton, California 92835
United States
Irvine Clinical Research
Irvine, California 92614
United States
Inglewood Clinical
Los Angeles, California 90056
United States
Stanford Neuroscience Health Center
Palo Alto, California 94304
United States
Local Institution - 0069
San Diego, California 92103
United States
Research of the Rockies
Colorado Springs, Colorado 80919
United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida 33912
United States
Local Institution - 0086
Hallandale, Florida 33009
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida 32216
United States
K2 MEDICAL Research THE VILLAGES
Lady Lake, Florida 32159
United States
Intercoastal Medical Group
Sarasota, Florida 34239
United States
USF Health Byrd Alzheimer's Institute
Tampa, Florida 33613
United States
Alzheimer's Research and Treatment Center
Wellington, Florida 33414
United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois 60640
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Josephson Wallack Munshower Neurology, PC
Indianapolis, Indiana 46256
United States
Local Institution - 0080
Watertown, Massachusetts 02472
United States
QUEST Research Institute
Farmington Hills, Michigan 48334
United States
Private Practice - Dr. Ronald Louis Schwartz
Hattiesburg, Mississippi 39401
United States
Local Institution - 0119
Ridgewood, New Jersey 07450
United States
The Cognitive and Research Center of New Jersey
Springfield, New Jersey 07081
United States
Advanced Clinical Institute
West Long Branch, New Jersey 07764
United States
Neurological Associates Albany
Albany, New York 12208
United States
Dent Neurosciences Research Center, Inc
Amherst, New York 14226
United States
University at Buffalo - UBMD Neurology
Buffalo, New York 14203
United States
Local Institution - 0078
Lake Success, New York 11042
United States
Keystone Clinical Studies
Plymouth Meeting, Pennsylvania 19462
United States
Local Institution - 0081
Dallas, Texas 75231
United States
Central Texas Neurology Consultants, PA
Round Rock, Texas 78681
United States
Rainier Clinical Research Center
Renton, Washington 98057
United States
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D. 1181
Argentina
Centro Médico Luquez
Córdoba, Córdoba Province X5006CBI
Argentina
Local Institution - 0025
Buenos Aires, C1428AQK
Argentina
CEN Centro Especializado en Neurociencias
Córdoba, 5000
Argentina
Instituto Médico DAMIC
Córdoba, X5003DCE
Argentina
Resolution Psychopharmacology Research Institute
Mendoza, 5502
Argentina
University of the Sunshine Coast Birtinya
Birtinya, Queensland 4575
Australia
Local Institution - 0055
Herston (rbwh Grounds), Queensland 4006
Australia
Griffith University - Gold Coast Campus
Southport, Queensland 4222
Australia
Austin Health
Ivanhoe, Victoria 3079
Australia
Local Institution - 0115
Fortaleza, Ceará 60135-237
Brazil
Local Institution - 0101
Maringá, Paraná 87015-180
Brazil
Ruschel Medicina e Pesquisa Clínica
Rio de Janeiro, 22270-060
Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000
Brazil
Terveystalo Oulu
Oulu, North Ostrobothnia 90100
Finland
Clinical Research Services Turku
Turku, Southwest Finland 20520
Finland
CRST Helsinki Oy
Helsinki, Uusimaa 00180
Finland
Terveystalo Ruoholahti
Helsinki, 00180
Finland
Itä-Suomen Yliopisto Kuopio
Kuopio, 70210
Finland
Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone
Marseille, Bouches-du-Rhône 13005
France
Local Institution - 0128
Tours, Centre-Val de Loire 37044 Cedex 8
France
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne 31000
France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
Lille, Hauts-de-France 59037
France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
Rennes, Ille-et-Vilaine 35000
France
Local Institution - 0127
Saint-Herblain, Loire-Atlantique 44800
France
Centre Hospitalier Universitaire Régional de Nancy
Nancy, Meurthe-et-Moselle 54035
France
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, Rhône 69500
France
Local Institution - 0017
Villefranche-sur-Saône, Rhône 69655
France
Bordeaux University Hospital - Pellegrin
Bordeaux, 33076
France
Assistance Publique Hôpitaux de Paris - Groupe Hospitalier 10e - Hôpital Lariboisière
Paris, 75010
France
Hôpital Broca
Paris, 75013
France
Pitie Salpetriere University Hospital
Paris, 75013
France
Les Hôpitaux Universitaires de Strasbourg - Hôpital de la Robertsau
Strasbourg, 67091
France
Ludwig-Maximilians-Universität München
Munich, Bavaria 80539
Germany
Universitätsmedizin Göttingen - Georg-August-Universität
Göttingen, Lower Saxony 37075
Germany
Private Practice - Dr. Irma Schöll
Bad Homburg, 61348
Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, 09111
Germany
Universitaetsklinikum Koeln
Cologne, 50937
Germany
Universitaetsklinikum Ulm
Ulm, 89081
Germany
University Hospital of Patras
Pátrai, Achaḯa 26504
Greece
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
Chaïdári, Attikí 124 62
Greece
Hygeia Hospital
Marousi, Attikí 151 23
Greece
Local Institution - 0059
Ioannina, Ioánnina 455 00
Greece
AHEPA University General Hospital of Thessaloniki
Thessaloniki, 546 36
Greece
University of Naples Federico II
Naples, Campania 80131
Italy
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia
Foggia, 71100
Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore
Roma, 00168
Italy
Inage Neurology and Memory Clinic
Inage, Chiba 263-0043
Japan
Local Institution - 0123
Matsudo, Chiba 271-0047
Japan
Imon Yukari Neurology Clinic
Hiroshima, Hiroshima 732-0066
Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken 761-0793
Japan
Local Institution - 0125
Kamakura, Kanagawa 247-8533
Japan
Kokankai Kokan Clinic
Kawasaki, Kanagawa 2100852
Japan
Nippon Medical School Musashi Kosugi Hospital
Kawasaki, Kanagawa 211-8533
Japan
Ina Central Hospital
Ina, Nagano 396-0033
Japan
National Hospital Organization Niigata Hospital
Kashiwazaki, Niigata 945-8585
Japan
Katayama Medical Clinic
Kurashiki, Okayama-ken 710-0813
Japan
Tominaga Clinic
Osaka, Osaka 5560015
Japan
National Hospital Organization Hizen Psychiatric Center
Yoshinogari-cho, Kanzaki-gun, Saga-ken 842-0192
Japan
Local Institution - 0037
Wako, Saitama 351-0111
Japan
Wako Hospital
Wako, Saitama 351-0111
Japan
Local Institution - 0107
Kyoto, 616-8255
Japan
Brain Research Center Den Bosch B.V.
's-Hertogenbosch, North Brabant 5223 LA
Netherlands
Brain Research Center
Amsterdam, North Holland 1081 GN
Netherlands
Brain Research Center Zwolle
Zwolle, Overijssel 8025 AZ
Netherlands
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship 32-600
Poland
Penta Hospitals Przychodnie, Wrocław Wejherowska
Wroclaw, Lower Silesian Voivodeship 54-239
Poland
Local Institution - 0108
Lublin, Lublin Voivodeship 20-064
Poland
EMC Silesia sp. z o.o.
Katowice, Silesian Voivodeship 40-353
Poland
Campus Neurológico Sénior
Torres Vedras, Lisbon District 2560-280
Portugal
Unidade Local de Saude de Matosinhos
Matosinhos Municipality, Porto District 4464-513
Portugal
Hospital de Braga
Braga, 4710-243
Portugal
Unidade Local de Saúde de Coimbra, E.P.E.
Coimbra, 3000 075
Portugal
Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira
Guimarães, 4800-055
Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto, 4050-014
Portugal
SCB Research Center
Bayamón, 00961
Puerto Rico
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest 041914
Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest 041914
Romania
Local Institution - 0113
Constanța, Constanța County 900675
Romania
Local Institution - 0042
Bucharest, 0
Romania
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, 507190
Romania
Fundació ACE
Barcelona, Barcelona [Barcelona] 08028
Spain
Policlinica Gipuzkoa
Donostia / San Sebastian, Basque Country 20014
Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008
Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid 28223
Spain
Hospital Universitario Doctor Peset
Valencia, Valenciana, Comunitat 46017
Spain
Complejo Hospitalario Ruber Juan Bravo
Madrid, 28006
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
NIHR Manchester Clinical Research Facility
Manchester, England M13 9WL
United Kingdom
The Maudsley Hospital
London, London, City of SE5 8AZ
United Kingdom
Local Institution - 0103
Edinburgh, Midlothian EH4 2XU
United Kingdom
Warneford Hospital
Oxford, Oxfordshire OX3 7JX
United Kingdom
Re:Cognition Health - Birmingham
Birmingham, B16 8LT
United Kingdom
Leeds and York Partnership NHS Foundation Trust
Leeds, LS9 7TF
United Kingdom
Local Institution - 0126
Motherwell, ML1 4UF
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
United Kingdom