[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571980":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":66,"centralContacts":70,"locations":75,"responsibleParty":95,"collaborators":98,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":45,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":45,"studyType":118,"phases":119,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":78,"whyStopped":45,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14,19,24,29,34],{"label":9,"type":10,"description":11,"interventionNames":12},"sirolimus 0.5 mg Arm","ACTIVE_COMPARATOR","Participant would receive 0.5 mg of sirolimus.",[13],"Drug: Sirolimus 0.5 Mg Oral Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"sirolimus 1 mg Arm","Participant would receive 1 mg of sirolimus.",[18],"Drug: Sirolimus 1Mg Oral Tablet",{"label":20,"type":10,"description":21,"interventionNames":22},"sirolimus 2 mg Arm","Participant would receive 2 mg of sirolimus.",[23],"Drug: Sirolimus 2 MG Oral Tablet",{"label":25,"type":10,"description":26,"interventionNames":27},"everolimus 0.5 mg Arm","Participant would receive 0.5 mg of Everolimus.",[28],"Drug: Everolimus 0.5 MG Oral Tablet",{"label":30,"type":10,"description":31,"interventionNames":32},"everolimus 1 mg Arm","Participant would receive 1 mg of Everolimus.",[33],"Drug: Everolimus 1 MG Oral Tablet",{"label":35,"type":10,"description":36,"interventionNames":37},"everolimus 2 mg Arm","Participant would receive 2 mg of Everolimus.",[38],"Drug: Everolimus 2 MG Oral Tablet",[40,46,50,54,58,62],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"DRUG","Sirolimus 0.5 Mg Oral Tablet","Sirolimus 0.5 mg oral tablets daily for 2 weeks and complete PK\u002FPD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng\u002Fml.",[9],null,{"type":41,"name":47,"description":48,"armGroupLabels":49,"otherNames":45},"Sirolimus 1Mg Oral Tablet","Sirolimus 1 mg oral tablets daily for 2 weeks and complete PK\u002FPD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng\u002Fml.",[15],{"type":41,"name":51,"description":52,"armGroupLabels":53,"otherNames":45},"Sirolimus 2 MG Oral Tablet","Sirolimus 2 mg oral tablets daily for 2 weeks and complete PK\u002FPD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng\u002Fml.",[20],{"type":41,"name":55,"description":56,"armGroupLabels":57,"otherNames":45},"Everolimus 0.5 MG Oral Tablet","Everolimus 0.5 mg oral tablets daily for 2 weeks and complete PK\u002FPD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng\u002Fml.",[25],{"type":41,"name":59,"description":60,"armGroupLabels":61,"otherNames":45},"Everolimus 1 MG Oral Tablet","Everolimus 1 mg oral tablets daily for 2 weeks and complete PK\u002FPD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng\u002Fml.",[30],{"type":41,"name":63,"description":64,"armGroupLabels":65,"otherNames":45},"Everolimus 2 MG Oral Tablet","Everolimus 2 mg oral tablets for daily for 2 weeks and complete PK\u002FPD testing. After the first 2 weeks, dose increase, or dose reduction will be made to obtain a stable blood level of 5-7 ng\u002Fml.",[35],[67],{"name":68,"affiliation":5,"role":69},"Irina Timofte, MD, MS","PRINCIPAL_INVESTIGATOR",[71],{"name":68,"role":72,"phone":73,"phoneExt":45,"email":74},"CONTACT","2163347534","Irina.Timofte@utsouthwestern.edu",[76],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-96.80667,32.78306,{"lat":88,"lon":87},[91],{"name":92,"role":72,"phone":93,"phoneExt":45,"email":94},"Rhoda Annoh Gordon, PharmD, MPH","2146457108","Rhoda.annohgordon@utsouthwestern.edu",{"type":69,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Irina Timofte","Associate Professor",[99,101],{"name":100,"class":6},"University of Maryland, Baltimore",{"name":102,"class":103},"National Institute on Aging (NIA)","NIH","100571980","phase-1-mtor-inhibitors-in-older-adults-100571980",false,"NCT06727305","MTOR Inhibitors in Older Adults","Characterization of mTOR Inhibitor Pharmacokinetics and Pharmacodynamics in Older Adults .","Inclusion Criteria:\n\n1. Community-dwelling adults\n2. Patients should be 65 Years and older\n3. Patients is able to understand and follow trial procedures\n\nExclusion Criteria:\n\n1. Creatinine clearance \\\u003C30 mL\u002Fmin;\n2. History of chronic liver disease;\n3. Uncontrolled Hypertension (i.e., systolic blood pressure \\>160 mm Hg);\n4. Hemorrhagic central nervous system (CNS) event within 1 year from screening visit;\n5. Thrombotic event (DVT,PE) within 1 year from screening visit if not on anticoagulation;\n6. Planned major surgical procedures;\n7. Cardiovascular diseases ( i.e., admission for heart failure or myocardial infarction within 12 months);\n8. Taking medication that increase or decrease sirolimus blood concentrations;\n9. Other investigational therapy received within 1 month prior to screening visit;\n10. History of dementia; 11 Dependence in any Katz Basic Activities of Daily Living.",true,"ALL","65 Years","80 Years",{"count":116,"type":117},60,"ESTIMATED","INTERVENTIONAL",[120,121],"PHASE1","PHASE2","Over the past decades, healthcare systems face significant challenges to meet the needs of an aging population due to progressive debility, functional decline and chronic diseases development. While there is a growing appreciation of the potential impact of mTOR inhibitors on slowing aging processes, preventing chronic disease and prolonging healthy lifespan, a major challenge in developing clinical trials to establish the clinical efficacy of mTOR inhibitors is the absence of pharmacokinetics (PK) and pharmacodynamics (PD) data in older adults. The proposed study will provide the foundation for future clinical trials assessing the role of mTOR inhibitors on aging related indications",[124],"Aging",[124,126,127],"Geriatic","Disability","2026-06-23",{"date":130,"type":131},"2026-06-25","ACTUAL",{"date":133,"type":131},"2026-05-11",{"date":135,"type":117},"2027-11-13",{"name":5,"class":6},1]