Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-01 @ 5:34 PM
Study NCT ID:
NCT06976203
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 586}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11)", 'timeFrame': 'At week 24'}, {'measure': "Clinician's Interview-Based Impression Plus Caregiver Input (CIBIC+)", 'timeFrame': 'At week 24'}], 'secondaryOutcomes': [{'measure': "Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living scale (ADCS-ADL)", 'timeFrame': 'At week 24'}, {'measure': 'Change from baseline in neuro psychiatric inventory (NPI) total score', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with adverse event of special interest (AESIs)', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with AEs leading to study intervention discontinuation', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with AEs leading to study discontinuation', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with AEs leading to death', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with clinically significant changes in vital signs', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with clinically significant changes in electrocardiogram (ECG) tests', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with clinically significant changes in Columbia-Suicide Severity Rating Scale (C-SSRS) tests', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with clinically significant changes in weight', 'timeFrame': 'At week 24'}, {'measure': 'Number of participants with clinically significant changes in safety laboratory tests', 'timeFrame': 'At week 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dementia', 'Cognitive Impairment', 'Kar-XT', 'KarX-EC', "Mild Alzheimer's Disease", "Moderate Alzheimer's Disease"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06976203.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy and safety of KarXT + KarX-EC for cognitive impairment in Alzheimer's Disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of Alzheimer's disease (AD), specifically at the mild (stage 4) or moderate (stage 5) dementia stages, as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria. The diagnosis of AD pathology must be confirmed through the 2024 revised NIA-AA Workgroup criteria using a stepwise diagnostic approach.\n* Participants must have an Mini-Mental State Examination (MMSE) score ranging from 12 through 22, inclusive, at the time of screening.\n* 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.\n* 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.\n\nExclusion Criteria:\n\nParticipants must not present with any significant or severe medical conditions that could compromise their safety, the ability to comply with or complete the study, or the integrity of the 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.\n\n* 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.\n* 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.\n* Participants must not have significant pathological findings on brain magnetic resonance imaging (MRI) at screening that could affect safety or interfere with study procedures.\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06976203', 'acronym': 'MINDSET 2', 'briefTitle': "A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease (MINDSET 2)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': "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)", 'orgStudyIdInfo': {'id': 'CN012-0052'}, 'secondaryIdInfos': [{'id': '2025-520747-32', 'type': 'OTHER', 'domain': 'EU CTR'}, {'id': 'U1111-1317-4515', 'type': 'OTHER', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'KarXT + KarX-EC', 'interventionNames': ['Drug: KarXT', 'Drug: KarX-EC']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'KarXT', 'type': 'DRUG', 'otherNames': ['BMS-986510'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['KarXT + KarX-EC']}, {'name': 'KarX-EC', 'type': 'DRUG', 'otherNames': ['BMS-986519'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['KarXT + KarX-EC']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jack Florin, Site 0072', 'role': 'CONTACT', 'phone': '714-381-0801'}], 'facility': 'Fullerton Neurology and Headache Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward Zamrini, Site 0091', 'role': 'CONTACT', 'phone': '706-863-9595'}], 'facility': 'Inglewood Clinical', 'geoPoint': {'lat': 33.96168, 'lon': -118.35313}}, {'zip': '92614', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Elly Lee, Site 0095', 'role': 'CONTACT', 'phone': '949-753-1663'}], 'facility': 'Irvine Clinical Research', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0083', 'role': 'CONTACT'}], 'facility': 'Local Institution - 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Dr. Ronald Louis Schwartz', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '07450', 'city': 'Ridgewood', 'state': 'New Jersey', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0119', 'geoPoint': {'lat': 40.97926, 'lon': -74.11653}}, {'zip': '07081', 'city': 'Springfield', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Papka, Site 0094', 'role': 'CONTACT', 'phone': '973-850-4622'}], 'facility': 'The Cognitive and Research Center of New Jersey', 'geoPoint': {'lat': 40.70491, 'lon': -74.31723}}, {'zip': '07764', 'city': 'West Long Branch', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Ornstein, Site 0075', 'role': 'CONTACT', 'phone': '732-807-4700'}], 'facility': 'Advanced Clinical Institute', 'geoPoint': {'lat': 40.29039, 'lon': -74.01764}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Richard Holub, Site 0077', 'role': 'CONTACT', 'phone': '518-426-0575'}], 'facility': 'Neurological Associates Albany', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14226', 'city': 'Amherst', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site 0068', 'role': 'CONTACT'}], 'facility': 'Local Institution - 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0027', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'C1428AQK', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Site 0025', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0025', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '5000', 'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Site 0028', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0028', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': 'X5003DCE', 'city': 'Córdoba', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Site 0030', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0030', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '5502', 'city': 'Mendoza', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'contacts': [{'name': 'Site 0026', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0026', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '4072', 'city': 'Saint Lucia', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site 0055', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0055', 'geoPoint': {'lat': -27.5, 'lon': 153.0}}, {'zip': '4556', 'city': 'Sippy Downs', 'state': 'Queensland', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site 0053', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0053', 'geoPoint': {'lat': -26.71793, 'lon': 153.05475}}, {'zip': '4222', 'city': 'Southport', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Philip Morris, Site 0056', 'role': 'CONTACT', 'phone': '+61422545753'}], 'facility': 'Griffith University - Gold Coast Campus', 'geoPoint': {'lat': -27.96724, 'lon': 153.39796}}, {'zip': '3079', 'city': 'Ivanhoe', 'state': 'Victoria', 'status': 'NOT_YET_RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Site 0054', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0054', 'geoPoint': {'lat': -37.76903, 'lon': 145.04308}}, {'zip': '60135-237', 'city': 'Fortaleza', 'state': 'Ceará', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Site 0115', 'role': 'CONTACT'}], 'facility': 'Local Institution - 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