Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-26 @ 1:57 AM
Study NCT ID:
NCT04691505
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2020-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Methotrexate vs Hydroxychloroquine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-30', 'size': 3718334, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-12-30T12:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133553}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-15', 'studyFirstSubmitDate': '2020-12-28', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to dementia onset', 'timeFrame': 'Through study completion (a median of 237 days)', 'description': "Time to dementia onset, i.e., Alzheimer's disease, vascular dementia, senile, presenile, or unspecified dementia, or dementia in other diseases classified elsewhere. Please refer to uploaded protocol for full definition due to size limitations."}], 'secondaryOutcomes': [{'measure': "Time to Alzheimer's disease onset", 'timeFrame': 'Through study completion (a median of 237 days)', 'description': "Time to Alzheimer's disease onset. Please refer to uploaded protocol for full definition due to size limitations."}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': "This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.", 'detailedDescription': "This is a non-randomized, non-interventional study that is part of the DREAM Study of Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of the Clinical and Translational Neuroscience Section, Laboratory of Behavioral Neuroscience, National Institute on Aging (NIA) intramural research program. This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will involve a new user, parallel group, cohort study design comparing methotrexate to hydroxychloroquine. The patients will be required to have continuous enrollment during the baseline period of 355 days before initiation of methotrexate or hydroxychloroquine (cohort entry date). Follow-up for the outcome (incident dementia), begins the day after drug initiation for analyses 1, 3, and 4 and 180 days after drug initiation for analysis 2.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Please see https://docs.google.com/spreadsheets/d/14HJn7W3NfPFcaowVDniCi9ulLRKRN2fn2jyeJjGgtzc/edit?usp=sharing or Appendix A for full code and algorithm definitions.\n\nMedicare timeframe: 2007 to 2017 (end of data availability).\n\nInclusion Criteria:\n\n* 1\\. No prior use of methotrexate or hydroxychloroquine anytime prior to cohort entry date\n* 2\\. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date\n\nExclusion Criteria:\n\n* 1\\. Prior history of dementia measured anytime prior to cohort entry date\n* 2\\. No prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date\n* 3\\. Prior history of nursing home admission in the 365 days prior to the cohort entry date\n* 4\\. Prior history of DMARD use measured anytime prior to cohort entry date'}, 'identificationModule': {'nctId': 'NCT04691505', 'briefTitle': "Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Methotrexate vs Hydroxychloroquine", 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': "Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines- Methotrexate vs Hydroxychloroquine", 'orgStudyIdInfo': {'id': '2019A010961-4'}, 'secondaryIdInfos': [{'id': '75N95019C00057', 'type': 'OTHER_GRANT', 'domain': 'National Institute on Aging'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Methotrexate', 'description': 'Reference group', 'interventionNames': ['Drug: Methotrexate']}, {'label': 'Hydroxychloroquine', 'description': 'Exposure group', 'interventionNames': ['Drug: Hydroxychloroquine']}], 'interventions': [{'name': 'Methotrexate', 'type': 'DRUG', 'description': 'Methotrexate is used as the reference group.', 'armGroupLabels': ['Methotrexate']}, {'name': 'Hydroxychloroquine', 'type': 'DRUG', 'description': 'Hydroxychloroquine is used as the exposure group.', 'armGroupLabels': ['Hydroxychloroquine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02120', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Rishi J Desai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Madhav Thambisetty, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute on Aging (NIA)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'Rutgers University', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Rishi J. Desai', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}