A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
- Conditions
- Alzheimer's Disease
- Interventions
- Registration Number
- NCT06976203
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 586
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description KarXT + KarX-EC KarXT - KarXT + KarX-EC KarX-EC - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) At week 24 Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+) At week 24
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) At week 24 Number of participants with adverse event of special interest (AESIs) At week 24 Number of participants with AEs leading to death At week 24 Change from baseline in neuro psychiatric inventory (NPI) total score At week 24 Number of participants with AEs leading to study intervention discontinuation At week 24 Number of participants with clinically significant changes in vital signs At week 24 Number of participants with clinically significant changes in electrocardiogram (ECG) tests At week 24 Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL) At week 24 Number of participants with AEs leading to study discontinuation At week 24 Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests At week 24 Number of participants with clinically significant changes in weight At week 24 Number of participants with clinically significant changes in safety laboratory tests At week 24 Number of participants with serious adverse events (SAEs) At week 24
Trial Locations
- Locations (115)
Local Institution - 0022
🇫🇮Oulu, Pohjois-Pohjanmaa, Finland
Local Institution - 0009
🇫🇮Turku, Varsinais-Suomi, Finland
Local Institution - 0008
🇫🇮Kuopio, Finland
Local Institution - 0018
🇫🇷Strasbourg, Alsace, France
Local Institution - 0020
🇫🇷Bron, Rhône, France
Local Institution - 0017
🇫🇷Gleize, Rhône, France
Local Institution - 0102
🇫🇷Paris, France
Local Institution - 0057
🇮🇹Napoli, Campania, Italy
Local Institution - 0067
🇮🇹Roma, Italy
Local Institution - 0016
🇫🇷Nancy, Meurthe-et-Moselle, France
Local Institution - 0021
🇫🇷Lille, Nord-Pas-de-Calais, France
Local Institution - 0014
🇫🇷Paris, France
Local Institution - 0036
🇫🇷Paris, France
Local Institution - 0109
🇬🇷Patras, Achaḯa, Greece
Local Institution - 0061
🇬🇷Marousi, AttikÃ, Greece
Local Institution - 0110
🇬🇷Thessaloniki, Greece
Local Institution - 0034
🇯🇵Kurashiki, Okayama, Japan
Local Institution - 0031
🇯🇵Yoshinogari, Saga, Japan
Local Institution - 0098
🇳🇱Zwolle, Overijssel, Netherlands
Local Institution - 0108
🇵🇱Lublin, Lubelskie, Poland
Local Institution - 0037
🇯🇵Wako, Saitama, Japan
Local Institution - 0112
🇯🇵Wako, Saitama, Japan
Local Institution - 0107
🇯🇵Kyoto, Japan
Local Institution - 0011
🇳🇱's-Hertogenbosch, Noord-Brabant, Netherlands
Local Institution - 0096
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0064
🇵🇱Wrocław, Dolnośląskie, Poland
Local Institution - 0051
🇵🇹Braga, Portugal
Local Institution - 0049
🇵🇹Coimbra, Portugal
Local Institution - 0063
🇵🇹Guimarães, Portugal
Local Institution - 0052
🇵🇹Porto, Portugal
Local Institution - 0074
🇵🇷Bayamon, Puerto Rico
Local Institution - 0041
🇷🇴Brașov, Brăila, Romania
Local Institution - 0039
🇷🇴Bucharest, București, Romania
Local Institution - 0040
🇷🇴Bucharest, București, Romania
Local Institution - 0113
🇷🇴Constanta, Constanța, Romania
Local Institution - 0042
🇷🇴București, Romania
Local Institution - 0062
🇪🇸Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0046
🇪🇸Santander, Cantabria, Spain
Local Institution - 0047
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Local Institution - 0043
🇪🇸San Sebastián, PaÃs Vasco, Spain
Local Institution - 0044
🇪🇸Valencia, Valenciana, Comunitat, Spain
Local Institution - 0048
🇪🇸Madrid, Spain
Local Institution - 0045
🇪🇸Madrid, Spain
Local Institution - 0097
🇬🇧Manchester, England, United Kingdom
Local Institution - 0111
🇬🇧Kippax, Leeds, United Kingdom
Local Institution - 0116
🇬🇧London, London, City Of, United Kingdom
Local Institution - 0103
🇬🇧Edinburgh, Midlothian, United Kingdom
Local Institution - 0010
🇬🇧Oxford, Oxfordshire, United Kingdom
Local Institution - 0005
🇬🇧Birmingham, United Kingdom
Local Institution - 0072
🇺🇸Fullerton, California, United States
Local Institution - 0090
🇺🇸Fort Myers, Florida, United States
Local Institution - 0091
🇺🇸Inglewood, California, United States
Local Institution - 0095
🇺🇸Irvine, California, United States
Local Institution - 0115
🇧🇷Fortaleza, Ceará, Brazil
Local Institution - 0099
🇧🇷Rio De Janeiro, Brazil
Local Institution - 0006
🇫🇮Helsinki, Finland
Local Institution - 0004
🇩🇪Munich, Bayern, Germany
Local Institution - 0023
🇩🇪Göttingen, Niedersachsen, Germany
Local Institution - 0002
🇩🇪Köln, Germany
Local Institution - 0106
🇯🇵Kawasaki, Kanagawa, Japan
Local Institution - 0083
🇺🇸Palo Alto, California, United States
Local Institution - 0086
🇺🇸Hallandale Beach, Florida, United States
Local Institution - 0070
🇺🇸Springfield, Illinois, United States
Local Institution - 0071
🇺🇸Indianapolis, Indiana, United States
Local Institution - 0073
🇺🇸Farmington Hills, Michigan, United States
Local Institution - 0085
🇺🇸Hattiesburg, Mississippi, United States
Local Institution - 0094
🇺🇸Springfield, New Jersey, United States
Local Institution - 0069
🇺🇸San Diego, California, United States
Local Institution - 0088
🇺🇸Denver, Colorado, United States
Local Institution - 0089
🇺🇸Wellington, Florida, United States
Local Institution - 0080
🇺🇸Watertown, Massachusetts, United States
Local Institution - 0077
🇺🇸Albany, New York, United States
Local Institution - 0081
🇺🇸Dallas, Texas, United States
Local Institution - 0079
🇺🇸Round Rock, Texas, United States
Local Institution - 0076
🇺🇸Renton, Washington, United States
Local Institution - 0025
🇦🇷Buenos Aires, Argentina
Local Institution - 0028
🇦🇷Córdoba, Argentina
Local Institution - 0054
🇦🇺Ivanhoe, Victoria, Australia
Local Institution - 0013
🇫🇷Toulouse, Haute-Garonne, France
Local Institution - 0024
🇩🇪Bad Homburg, Hessen, Germany
Local Institution - 0001
🇩🇪Chemnitz, Sachsen, Germany
Local Institution - 0059
🇬🇷Ioannina, Ioánnina, Greece
Local Institution - 0038
🇯🇵Ina, Nagano, Japan
Local Institution - 0035
🇯🇵Osaka-Shi, Osaka, Japan
Local Institution - 0092
🇺🇸Jacksonville, Florida, United States
Local Institution - 0082
🇺🇸Sarasota, Florida, United States
Local Institution - 0084
🇺🇸Tampa, Florida, United States
Local Institution - 0114
🇺🇸The Villages, Florida, United States
Local Institution - 0093
🇺🇸Chicago, Illinois, United States
Local Institution - 0075
🇺🇸West Long Branch, New Jersey, United States
Local Institution - 0068
🇺🇸Amherst, New York, United States
Local Institution - 0078
🇺🇸Lake Success, New York, United States
Local Institution - 0026
🇦🇷Mendoza, Argentina
Local Institution - 0055
🇦🇺Brisbane, Queensland, Australia
Local Institution - 0101
🇧🇷Maringa, Paraná, Brazil
Local Institution - 0100
🇧🇷São Paulo, Brazil
Local Institution - 0087
🇺🇸Buffalo, New York, United States
Local Institution - 0105
🇺🇸Plymouth Meeting, Pennsylvania, United States
Local Institution - 0029
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Local Institution - 0027
🇦🇷Cordoba, Córdoba, Argentina
Local Institution - 0030
🇦🇷Córdoba, Argentina
Local Institution - 0007
🇫🇮Helsinki, Uusimaa, Finland
Local Institution - 0015
🇫🇷Marseille, Bouches-du-Rhône, France
Local Institution - 0019
🇫🇷Rennes, Ille-et-Vilaine, France
Local Institution - 0012
🇫🇷Bordeaux, France
Local Institution - 0003
🇩🇪Ulm, Germany
Local Institution - 0060
🇬🇷Chaidari, AttikÃ, Greece
Local Institution - 0058
🇮🇹Foggia, Italy
Local Institution - 0033
🇯🇵Kashiwazaki, Niigata, Japan
Local Institution - 0066
🇵🇱Oswiecim, MA, Poland
Local Institution - 0065
🇵🇱Katowice, Śląskie, Poland
Local Institution - 0050
🇵🇹Torres Vedras, Lisboa, Portugal
Local Institution - 0104
🇵🇹Matosinhos, Porto, Portugal
Local Institution - 0053
🇦🇺Sippy Downs, Queensland, Australia
Local Institution - 0056
🇦🇺Southport, Queensland, Australia