Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-03 @ 1:44 AM
Study NCT ID:
NCT05598359
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-28
First Post:
2022-10-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TA-65 and Aging Associated Microvascular Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014652', 'term': 'Vascular Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2022-10-18', 'studyFirstSubmitQcDate': '2022-10-24', 'lastUpdatePostDateStruct': {'date': '2025-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nitric Oxide Mediated Endothelium-Dependent Vasodilation via Laser Doppler Flowmetry Coupled with Intradermal Microdialysis', 'timeFrame': '28 days', 'description': 'Cutaneous microvascular function measured via laser Doppler flowmetry coupled with intradermal microdialysis of non-specific nitric oxide synthase inhibitor, L-NAME'}], 'secondaryOutcomes': [{'measure': 'Systemic Blood Pressure', 'timeFrame': '28 days', 'description': 'Brachial systolic, and diastolic blood pressure will be measured via standard brachial blood pressure cuff'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Telomere Shortening', 'Aging', 'Vascular Diseases']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test whether activation of telomerase with a dietary supplement (TA-65) improves microvascular function.', 'detailedDescription': 'The purpose of this clinical trial is to examine whether activation of autophagy with TA-65 which activates telomerase, improves microvascular function and blood pressure in an older population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Adults 18 - 35 and 65+ years of age\n* Subjects with clinical diagnosis of CAD\n\nExclusion criteria will include:\n\n* 36-64 years of age without clinical diagnosis of CAD\n* Self-reported habitual vigorous exercise (\\>20 min, 3 times per week, 1 yr)\n* Major Adverse Cardiovascular Event (MACE) in the last year (heart attack, stroke)\n* Heart Failure\n* Renal Impairment\n* \\>3 Pre-existing Cardiovascular Risk Factors (healthy groups only)\n* Type 1 or type 2 diabetes\n* Uncontrolled hypertension\n* Current tobacco use or within last 6 months\n* BMI \\> 35\n* Hyperlipidemia\n* Hypercholesterolemia\n* Use of anti-coagulant drugs\n* Use of anti-platelet drugs\n* Erectile dysfunction medication in the past 6 months\n* Use of topical/non-topical steroids in last 6 months\n* Hormone replacement therapy (Post-Menopause or Gender Reassignment)\n* History of retinopathy\n* Documented neuromuscular disorders\n* Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity)\n* Pregnancy (young female subjects)\n* Allergy to lidocaine\n* Current diagnosis of cancer with or without active anti-cancer treatment (pharmaceuticals) or treatment within last 12 months\n* Active COVID-19 or within the past 3 months'}, 'identificationModule': {'nctId': 'NCT05598359', 'briefTitle': 'TA-65 and Aging Associated Microvascular Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Medical College of Wisconsin'}, 'officialTitle': 'TA-65 and Aging Associated Microvascular Dysfunction', 'orgStudyIdInfo': {'id': 'TA-65 and Vascular Aging'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TA-65', 'description': 'TA-65 (250 U) taken once per day', 'interventionNames': ['Dietary Supplement: TA-65']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo taken once per day', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'TA-65', 'type': 'DIETARY_SUPPLEMENT', 'description': 'TA-65 is a purified small molecule extracted from Astragalus root', 'armGroupLabels': ['TA-65']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Inactive formulation', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Andreas Beyer, Ph.D.', 'role': 'CONTACT', 'email': 'abeyer@mcw.edu', 'phone': '414-955-7514'}, {'name': 'William Hughes, Ph.D.', 'role': 'CONTACT', 'email': 'whughes@mcw.edu', 'phone': '414-955-7519'}], 'overallOfficials': [{'name': 'Andreas Beyer, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data available upon record completion', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical College of Wisconsin', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Louisville', 'class': 'OTHER'}, {'name': 'Penn State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Postdoc Fellow', 'investigatorFullName': 'William Hughes', 'investigatorAffiliation': 'Medical College of Wisconsin'}}}}