A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
NCT ID: NCT06976203
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
586 participants
INTERVENTIONAL
2025-07-21
2029-02-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KarXT + KarX-EC
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.
* Participants must have a designated caregiver who maintains adequate contact (around 10 hours per week or more) and is willing to attend all study visits. The caregiver must also be responsible for reporting on the participant's condition, overseeing medication compliance, and consenting to their involvement in both their own and the participant's study-related activities.
* Participants on acetyl choline esterase inhibitors (AChEIs) and/or memantine, must have been on a stable dosage for at least 12 weeks prior to screening, and agree to maintain this stable dose for the study duration.
Exclusion Criteria
* Participants must not have any primary psychiatric diagnoses such as major depression, schizoaffective disorder, or bipolar disorder, and those with severe psychiatric symptoms that could complicate the interpretation of treatment effects, impair cognitive assessment, or impact study completion.
* Participants must not have a history of schizophrenia or other chronic psychosis, as well as those who have previously been exposed to KarXT or are currently undergoing treatment with disease-modifying anti-amyloid therapies for AD within the past 6 months prior to screening.
* Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.
60 Years
85 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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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
Local Institution - 0088
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
Local Institution - 0082
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
Local Institution - 0094
Springfield, New Jersey, United States
Advanced Clinical Institute
West Long Branch, New Jersey, United States
Neurological Associates Albany
Albany, New York, United States
Local Institution - 0068
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
Local Institution - 0076
Renton, Washington, United States
Local Institution - 0029
ABB, Buenos Aires F.D., Argentina
Local Institution - 0027
Córdoba, Córdoba Province, Argentina
Local Institution - 0025
Buenos Aires, , Argentina
Local Institution - 0028
Córdoba, , Argentina
Local Institution - 0030
Córdoba, , Argentina
Local Institution - 0026
Mendoza, , Argentina
Local Institution - 0055
Saint Lucia, Queensland, Australia
Local Institution - 0053
Sippy Downs, Queensland, Australia
Local Institution - 0056
Southport, Queensland, Australia
Local Institution - 0054
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
Local Institution - 0022
Oulu, North Ostrobothnia, Finland
Local Institution - 0009
Turku, Southwest Finland, Finland
Local Institution - 0007
Helsinki, Uusimaa, Finland
Local Institution - 0006
Helsinki, , Finland
Local Institution - 0008
Kuopio, , Finland
Local Institution - 0015
Marseille, Bouches-du-Rhône, France
Centre Hospitalier Universitaire Toulouse - Cité de la Santé
Toulouse, Haute-Garonne, France
Local Institution - 0021
Lille, Hauts-de-France, France
Local Institution - 0019
Rennes, Ille-et-Vilaine, France
Local Institution - 0016
Nancy, Meurthe-et-Moselle, France
Hospices Civils de Lyon - Hôpital Pierre Wertheimer
Bron, Rhône, France
Local Institution - 0017
Villefranche-sur-Saône, Rhône, France
Local Institution - 0012
Bordeaux, , France
Local Institution - 0014
Paris, , France
Local Institution - 0036
Paris, , France
Local Institution - 0102
Paris, , France
Local Institution - 0018
Strasbourg, , France
Local Institution - 0004
Munich, Bavaria, Germany
Local Institution - 0023
Göttingen, Lower Saxony, Germany
Local Institution - 0024
Bad Homburg, , Germany
Pharmakologisches Studienzentrum Chemnitz
Chemnitz, , Germany
Local Institution - 0002
Cologne, , Germany
Local Institution - 0003
Ulm, , Germany
Local Institution - 0109
Pátrai, Achaḯa, Greece
Local Institution - 0060
Chaïdári, Attikí, Greece
Local Institution - 0061
Marousi, Attikí, Greece
Local Institution - 0059
Ioannina, Ioánnina, Greece
Local Institution - 0110
Thessaloniki, , Greece
Local Institution - 0057
Napoli, Campania, Italy
Local Institution - 0058
Foggia, , Italy
Local Institution - 0067
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 - 0122
Kawasaki, Kanagawa, Japan
Local Institution - 0106
Kawasaki, Kanagawa, Japan
Local Institution - 0038
Ina, Nagano, Japan
Local Institution - 0033
Kashiwazaki, Niigata, Japan
Local Institution - 0034
Kurashiki, Okayama-ken, Japan
Local Institution - 0035
Osaka, Osaka, Japan
Local Institution - 0031
Yoshinogari-cho, Kanzaki-gun, Saga-ken, Japan
Local Institution - 0037
Wako, Saitama, Japan
Local Institution - 0112
Wako, Saitama, Japan
Local Institution - 0107
Kyoto, , Japan
Local Institution - 0011
's-Hertogenbosch, North Brabant, Netherlands
Local Institution - 0096
Amsterdam, North Holland, Netherlands
Local Institution - 0098
Zwolle, Overijssel, Netherlands
Local Institution - 0066
Oświęcim, Lesser Poland Voivodeship, Poland
Local Institution - 0064
Wroclaw, Lower Silesian Voivodeship, Poland
Local Institution - 0108
Lublin, Lublin Voivodeship, Poland
Local Institution - 0065
Katowice, Silesian Voivodeship, Poland
Local Institution - 0050
Torres Vedras, Lisbon District, Portugal
Local Institution - 0104
Matosinhos Municipality, Porto District, Portugal
Local Institution - 0051
Braga, , Portugal
Local Institution - 0049
Coimbra, , Portugal
Local Institution - 0063
Guimarães, , Portugal
Local Institution - 0052
Porto, , Portugal
SCB Research Center
Bayamón, , Puerto Rico
Local Institution - 0039
Bucharest, București, Romania
Local Institution - 0040
Bucharest, București, Romania
Local Institution - 0113
Constanța, Constanța County, Romania
Local Institution - 0042
Bucharest, , Romania
Local Institution - 0041
Sanpetru /Brasov, , Romania
Local Institution - 0062
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0043
Donostia / San Sebastian, Basque Country, Spain
Local Institution - 0046
Santander, Cantabria, Spain
Local Institution - 0047
Pozuelo de Alarcón, Madrid, 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
Re:Cognition Health - Birmingham
Birmingham, , United Kingdom
Countries
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Central Contacts
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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Role: CONTACT
Phone: 8559073286
Email: [email protected]
First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Jack Florin, Site 0072
Role: primary
Edward Zamrini, Site 0091
Role: primary
Elly Lee, Site 0095
Role: primary
Site 0083
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Site 0088
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Jennifer Springer, Site 0090
Role: primary
Beth Safirstein, Site 0086
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Steven Toenjes, Site 0092
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Craig Curtis, Site 0114
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Site 0082
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Amanda Smith, Site 0084
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David Watson, Site 0089
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Jeffrey Ross, Site 0093
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Jennifer Arnold, Site 0070
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Kristi George, Site 0071
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Site 0080
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Aaron Ellenbogen, Site 0073
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Ronald Schwartz, Site 0085
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Site 0094
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Mark Ornstein, Site 0075
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Richard Holub, Site 0077
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Site 0068
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Kinga Szigeti, Site 0087
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Cameron Olezene, Site 0105
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Site 0081
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Elizabeth Peckham, Site 0079
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Site 0115
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Site 0015
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Pierre-Jean Ousset, Site 0013
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Site 0021
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Site 0019
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Site 0016
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Helene MOLLION, Site 0020
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Site 0012
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Site 0014
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Site 0036
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Site 0102
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Site 0018
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Site 0004
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Site 0023
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Ralf Bodenschatz, Site 0001
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Site 0003
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Site 0109
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Site 0060
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Site 0059
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William Julio, Site 0074
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Site 0097
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Site 0116
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Site 0103
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Site 0010
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Terence McLoughlin, Site 0005
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0052
Identifier Type: -
Identifier Source: org_study_id