Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT05635357
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2022-11-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077384', 'term': 'Anastrozole'}, {'id': 'C056516', 'term': 'exemestane'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-07', 'size': 1867454, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-07T16:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16989}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-25', 'studyFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2022-12-01', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to dementia onset', 'timeFrame': 'up to 6 years', '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': 'up to 6 years', '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': ['Breast Cancer']}, '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 Anastrozole vs Exemestane/Letrozole. 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/1GrnVsPCockqqdfxC9LWd6ndbzS2wpJVvTbCOAhn4DLM/edit?usp=sharing or Appendix A (https://drive.google.com/drive/folders/1I8FVmpPzC5wQN9DFIv1Rbwh1N0SLEv0B?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\\. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior to and including cohort entry date\n* 3\\. At least two claims with breast cancer 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 anytime prior to cohort entry date\n* 3\\. Prior history of Anastrozole or Exemestane/Letrozole use anytime prior to cohort entry date'}, 'identificationModule': {'nctId': 'NCT05635357', 'briefTitle': "Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole", 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': "Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole", 'orgStudyIdInfo': {'id': '2019P003607-11'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anastrozole', 'description': 'Exposure group', 'interventionNames': ['Drug: Anastrozole']}, {'label': 'Exemestane/Letrozole', 'description': 'Reference group', 'interventionNames': ['Drug: Exemestane/Letrozole']}], 'interventions': [{'name': 'Anastrozole', 'type': 'DRUG', 'description': 'Anastrozole claim is used as the exposure group.', 'armGroupLabels': ['Anastrozole']}, {'name': 'Exemestane/Letrozole', 'type': 'DRUG', 'description': 'Exemestane/Letrozole claim is used as the reference group.', 'armGroupLabels': ['Exemestane/Letrozole']}]}, '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"}}}}