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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)

Study acronym: MINDSET 2
StatusRecruiting
PhasePhase 3
Started2025-07-21
View on ClinicalTrials.gov ↗

Amendment history

2026-08-11
minor
Study Status, Contacts/Locations v20
Study sites126 entries, revised
Rainier Clinical Research Center Local Institution - 01260076 NeuroClin Glasgow
2026-07-16
minor
Study Status, Contacts/Locations v19
Study sites126 entries, revised
LocalStanford InstitutionNeuroscience -Health 0083Center USCUniversity Clinicalof Trialsthe Sunshine Coast Birtinya LocalLudwig-Maximilians-Universität Institution - 0004München
2026-06-25
minor
Study Status, Contacts/Locations v18
Study sites126 entries, revised
LocalImon InstitutionYukari -Neurology 0124Clinic LocalKagawa InstitutionUniversity - 0120Hospital
2026-06-05
minor
Study Status, Contacts/Locations v17
Study sites124→126
2026-05-19
minor
Study Status, Contacts/Locations v16
Study sites123→124
Show 15 earlier versions
2026-04-29
minor
Study Status, Contacts/Locations v15
Study sites123 entries, revised
LocalHospital InstitutionItaliano -de 0029Buenos Aires LocalInstituto InstitutionMédico -DAMIC AHEPA 0030University General Hospital of Thessaloniki LocalInage InstitutionNeurology -and 0110 LocalMemory Institution - 0121Clinic
2026-03-30
minor
Study Status, Contacts/Locations v14
Study sites121→123
2026-03-04
minor
Study Status, Contacts/Locations v13
Study sites121 entries, revised
LocalResearch Institutionof the Rockies Dent Neurosciences Research Center, Inc CEN Centro Especializado en Neurociencias Universitätsmedizin Göttingen - 0088Georg-August-Universität LocalInstytut InstitutionZdrowia -Dr 0068Boczarska Jedynak LocalEMC InstitutionSilesia -sp. 0028z o.o. LocalNIHR InstitutionManchester -Clinical 0023 LocalResearch Institution - 0066 Local Institution - 0065 Local Institution - 0097Facility
2026-02-12
minor
Study Status, Contacts/Locations, IPDSharing v12
Study sites121 entries, revised
LocalCentro InstitutionMédico -Luquez Austin 0027Health LocalClinical InstitutionResearch -Services 0054Turku LocalUniversitaetsklinikum InstitutionUlm Hygeia -Hospital University 0009of Naples Federico II LocalNippon InstitutionMedical -School 0003Musashi Kosugi Hospital LocalTominaga InstitutionClinic Wako -Hospital The 0061 LocalMaudsley Institution - 0057 Local Institution - 0106 Local Institution - 0035 Local Institution - 0112 Local Institution - 0116Hospital
2026-01-09
minor
Study Status, Contacts/Locations v11
Study sites121 entries, revised
LocalTerveystalo InstitutionRuoholahti University General Hospital "ATTIKON" - 0006General Hospital of West Attica "H AGIA VARVARA" LocalAzienda InstitutionOspedaliero -Universitaria 0060Policlinico Riuniti di Foggia LocalKokankai InstitutionKokan -Clinic National 0058Hospital Organization Niigata Hospital LocalComplejo InstitutionHospitalario -Ruber 0122 LocalJuan Institution - 0033 Local Institution - 0048Bravo
2025-12-22
minor
Study Identification, Study Status, Eligibility, Contacts/Locations v10
Eligibility criteria+142 characters
Inclusion Criteria: Participants must have a confirmed diagnosis of Alzheimer's [...] this stable dose for the study duration. Exclusion Criteria: Participants must not present with any significant or sever [...] 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 diagnos [...]
Study sites121 entries, revised
LocalAssistance InstitutionPublique Hôpitaux de Marseille - 0015Hôpital de la Timone LocalCentre InstitutionHospitalier Universitaire Régional de Nancy Hôpital Broca Pitie Salpetriere University Hospital Les Hôpitaux Universitaires de Strasbourg - 0016Hôpital de la Robertsau LocalFondazione InstitutionPoliclinico Universitario Agostino Gemelli IRCCS - 0036Università Cattolica del Sacro Cuore LocalCampus InstitutionNeurológico -Sénior Hospital 0102de Braga LocalPoliclinica Institution - 0018 Local Institution - 0067 Local Institution - 0050 Local Institution - 0051 Local Institution - 0043Gipuz [...]
2025-12-08
minor
Study Status, Contacts/Locations v9
Study sites121 entries, revised
LocalGriffith InstitutionUniversity - 0056Gold Coast Campus LocalCRST InstitutionHelsinki Oy Itä-Suomen 0007Yliopisto Kuopio LocalNational InstitutionHospital -Organization 0008Hizen Psychiatric Center LocalProf. InstitutionDr. -Alexandru 0031Obregia Psychiatry Hospital LocalFundació InstitutionACE Hospital -Universitario 0040Marqués de Valdecilla LocalHospital InstitutionUniversitario -Doctor 0062Peset LocalHospital InstitutionUniversitario -12 0046de Octubre LocalWarneford Institution - 0044 Local Institution - 0045 Local Institution - 0010Hospital
2025-12-01
minor
Study Status, Contacts/Locations v8
Study sites121 entries, revised
LocalIntercoastal InstitutionMedical Group The Cognitive and Research Center of New Jersey Rainier Clinical Research Center Terveystalo Oulu Centre Hospitalier Régional Universitaire de Lille - 0082Hôpital Roger Salengro LocalCentre InstitutionHospitalier Universitaire de Rennes - 0094Hôpital Pontchaillou LocalBordeaux InstitutionUniversity Hospital - 0076Pellegrin LocalAssistance InstitutionPublique Hôpitaux de Paris - 0022 LocalGroupe InstitutionHospitalier 10e - 0021Hôpital Lariboisière LocalPrivate InstitutionPractice - 0019Dr. Irma Schöll LocalUniversitaetsklinikum InstitutionKoeln Kataya [...] [...]
2025-11-11
minor
Study Status, Contacts/Locations v7
Study sites120→121
2025-10-20
minor
Study Status, Contacts/Locations v6
Study sites120 entries, revised
LocalInglewood InstitutionClinical Private Practice - 0091Dr. Ronald Louis Schwartz LocalCentral InstitutionTexas -Neurology 0085Consultants, PA LocalSCB InstitutionResearch - 0079 Local Institution - 0074Center
2025-09-22
minor
Study Status, Contacts/Locations v5
Study sites120 entries, revised
LocalIrvine InstitutionClinical Research Neuropsychiatric Research Center of Southwest Florida Southern Illinois University School of Medicine QUEST Research Institute Keystone Clinical Studies Re:Cognition Health - 0095 Local Institution - 0090 Local Institution - 0070 Local Institution - 0073 Local Institution - 0105 Local Institution - 0005Birmingham
2025-08-26
minor
Study Status, Contacts/Locations v4
Study sites116→120
2025-08-15
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-07-25→confirmed 2025-07-21
Study sites116 entries, revised
LocalFullerton InstitutionNeurology and Headache Center Great Lakes Clinical Trials - 0072Andersonville LocalNeurological InstitutionAssociates - 0093 Local Institution - 0077Albany
2025-07-14
minor
Study Status, Contacts/Locations v2
Study sites115→116
2025-06-16
minor
Study Status, Contacts/Locations, References v1
Study sitesdetails revised at 2 of 115 sites
2025-05-09
minor
Original filing
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
Trial Details
NCT Number NCT06976203
Lead Sponsor Bristol-Myers Squibb
Conditions Alzheimer's Disease
Enrollment 586 participants
Start Date 2025-07-21
Primary Completion 2028-09-11 (estimated)
Study Completion 2029-02-23 (estimated)
Updated on ClinicalTrials.gov 2026-09-17