Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-02 @ 6:34 AM
Study NCT ID:
NCT05457868
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2022-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-22', 'size': 527931, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-22T12:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2022-07-11', 'studyFirstSubmitQcDate': '2022-07-11', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to dementia onset', 'timeFrame': 'Through study completion (a median of 120 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 120 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': ['Chronic Obstructive Pulmonary Disease']}, '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': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will employ a new user, active comparator, observational cohort study design comparing Salbutamol versus Long-acting muscarinic antagonists (LAMAs). The patients will be required to have continuous enrollment during the baseline period of 365 days before initiation of study drugs (cohort entry/index date). Follow-up for the outcome (dementia) differs between analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days after drug initiation (analysis 2).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Please see https://docs.google.com/spreadsheets/d/1j53\\_NBnEVQik4Ps5a9pZOvuHm1mWHCRZ3DAvI0y8NO8/edit?usp=sharing or Appendix A (https://drive.google.com/file/d/1uC\\_G8TJ1ujoJbas1p1gFaYFzY7Hw7xMq/view?usp=sharing) for full code and algorithm definitions.\n\nMedicare timeframe: 2008 to 2018 (end of data availability).\n\nInclusion Criteria:\n\n* 1\\. Aged \\>/= 65 years on the index date\n* 2\\. No prior use of Salbutamol and Long-acting Muscarinic Antagonists (LAMA) anytime prior to cohort entry date\n* 3\\. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date\n* 4\\. At least two claims with COPD diagnosis measured 365 days prior to drug initiation\n\nExclusion Criteria:\n\n* 1\\. Prior history of dementia measured anytime prior to cohort entry date\n* 2\\. Prior history of nursing home admission in the 365 days prior to the cohort entry date'}, 'identificationModule': {'nctId': 'NCT05457868', 'briefTitle': "Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists", 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': "Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Salbutamol vs Long-acting Muscarinic Antagonists", 'orgStudyIdInfo': {'id': '2019A010961-9'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Salbutamol', 'description': 'Exposure group', 'interventionNames': ['Drug: Salbutamol']}, {'label': 'Long-acting muscarinic antagonists (LAMA)', 'description': 'Reference group', 'interventionNames': ['Drug: LAMA']}], 'interventions': [{'name': 'Salbutamol', 'type': 'DRUG', 'description': 'Salbutamol claim is used as the exposure group.', 'armGroupLabels': ['Salbutamol']}, {'name': 'LAMA', 'type': 'DRUG', 'description': 'Long-acting muscarinic antagonists (LAMA) - umeclidinium, aclidinium, tiotropium, glycopyrolate, glycopyrronium - claim is used as the reference group.', 'armGroupLabels': ['Long-acting muscarinic antagonists (LAMA)']}]}, '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': '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 of Medicine', 'investigatorFullName': 'Rishi J. Desai', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}