Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-03 @ 8:39 PM
Study NCT ID:
NCT03821857
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2019-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591008', 'term': '7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole'}, {'id': 'C475519', 'term': "2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole"}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 614}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2019-01-25', 'studyFirstSubmitQcDate': '2019-01-28', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18F-Flortaucipir PET imaging', 'timeFrame': '1 day', 'description': 'Cortical 18F-Flortaucipir PET imaging measured once in each participant'}, {'measure': 'Pittsburgh compound-B PET imaging', 'timeFrame': '1 day', 'description': 'Global cortical SUVR measured once in each participant'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The researchers are trying to determine whether ovarian hormones are associated with aging processes and with the risk of developing Alzheimer's disease in women.", 'detailedDescription': 'The proposed project will enroll a total of 614 women.\n\nMayo Clinic Rochester Participants: Each women will have 2-3 clinic visits consisting of cognitive testing, tests of physical function, questionnaires, and a blood draw. All women will also undergo clinical neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451. All participants will have previously participated and will return by invitation only.\n\nMayo Clinic Jacksonville Participant: Only African American Women will be enrolled at this site. Each women will have 1-3 clinic visits consisting of physical function testing and neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Mayo Clinic Rochester-\n\nInclusion Criteria:\n\n* Women who previously participated in this study\n* Currently aged 60 years and older\n* More than six months post chemotherapy or major surgery requiring general anesthesia\n* Willing and able to sign informed consent\n\nExclusion Criteria:\n\n* Not able to read and speak English\n* In hospice\n* Claustrophobic\n* If undergoing Tau imaging, cannot have QT Prolongation\n\nMayo Clinic Jacksonville-\n\nInclusion Criteria:\n\n* African American Women\n* Currently aged 60 years and older\n* More than six months post chemotherapy or major surgery requiring general anesthesia\n* Willing and able to sign informed consent\n\nExclusion Criteria:\n\n* Not able to read and speak English\n* In hospice\n* Claustrophobic\n* If undergoing Tau imaging, cannot have QT Prolongation'}, 'identificationModule': {'nctId': 'NCT03821857', 'acronym': 'SEED-AD', 'briefTitle': "Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': "Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease", 'orgStudyIdInfo': {'id': '18-008476'}, 'secondaryIdInfos': [{'id': 'U54AG044170-09', 'link': 'https://reporter.nih.gov/quickSearch/U54AG044170-09', 'type': 'NIH'}, {'id': 'R01AG093767', 'link': 'https://reporter.nih.gov/quickSearch/R01AG093767', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women', 'description': '18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology', 'interventionNames': ['Drug: 18-F-Flortaucipir']}], 'interventions': [{'name': '18-F-Flortaucipir', 'type': 'DRUG', 'otherNames': ['11C-Pittsburgh Compound-B'], 'description': 'Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology', 'armGroupLabels': ['Women']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Twilla Morrell, CRC', 'role': 'CONTACT', 'email': 'morrell.twila@mayo.edu', 'phone': '904-953-3420'}, {'name': 'Ercilia Moncayo, CRC', 'role': 'CONTACT', 'email': 'moncayo.ercilia@mayo.edu', 'phone': '904-953-3308'}, {'name': 'Neill Graff-Radford, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'ENROLLING_BY_INVITATION', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'centralContacts': [{'name': 'June Kendall-Thomas, CRC', 'role': 'CONTACT', 'email': 'kendallthomas.june15@mayo.edu', 'phone': '507-293-9397'}, {'name': 'Desirae Howe-Clayton, CRC', 'role': 'CONTACT', 'email': 'howe.desirae@mayo.edu', 'phone': '507-255-0111'}], 'overallOfficials': [{'name': 'Kejal Kantarci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kejal Kantarci', 'investigatorAffiliation': 'Mayo Clinic'}}}}