[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566662":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":60,"centralContacts":64,"locations":74,"responsibleParty":94,"collaborators":97,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":69,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":76,"whyStopped":69,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"The University of Texas Health Science Center at San Antonio","OTHER",[8,14,19,23,27,31,35],{"label":9,"type":10,"description":11,"interventionNames":12},"Aim 1:Sub-study 2 Daily dosing Cohort Rapamycin","EXPERIMENTAL","Aim 1 is an open label, adaptive, dose finding PK\u002FPD trial in older women and men.\n\nIn sub-study 2 (part of Aim 1), an older cohort will be studied to determine the optimal dose (OD) in milligrams of rapamycin (RAPA) based on changes in PD parameters 'downstream' from mTOR. Based on the data acquired, additional older cohorts will be tested at higher\u002Flower doses in an adaptive, step-wise trial design.",[13],"Drug: Rapamycin",{"label":15,"type":10,"description":16,"interventionNames":17},"Aim 1: Sub-study 2 Daily dosing Cohort Everolimus","Aim 1 is an open label, adaptive, dose finding PK\u002FPD trial in older women and men.\n\nIn sub-study 2 (part of Aim 1), an older cohort will be studied to determine the optimal dose (OD) of everolimus (EVERO) in milligrams based on changes in PD parameters 'downstream' from mTOR. Based on the data acquired, additional older cohorts will be tested at higher\u002Flower doses in an adaptive, step-wise trial design.",[18],"Drug: Everolimus",{"label":20,"type":10,"description":21,"interventionNames":22},"Aim 1:Sub-study 2 Intermittent dosing Cohort Rapamycin","Aim 1 is an open label, adaptive, dose finding PK\u002FPD trial in older women and men.\n\nIn sub-study 2 (part of Aim 1), an older cohort will be studied to determine the optimal dose (OD) in milligrams and the optimal interval for intermittent delivery of rapamycin (RAPA) based on changes in PD parameters 'downstream' from mTOR. Based on the data acquired, additional older cohorts will be tested at higher\u002Flower doses in an adaptive, step-wise trial design.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Aim 1: Sub-study 2 Intermittent dosing Cohort Everolimus","Aim 1 is an open label, adaptive, dose finding PK\u002FPD trial in older women and men.\n\nIn sub-study 2 (part of Aim 1), an older cohort will be studied to determine the optimal dose (OD) in milligrams and the optimal interval for intermittent delivery of everolimus (EVERO) based on changes in PD parameters 'downstream' from mTOR. Based on the data acquired, additional older cohorts will be tested at higher\u002Flower doses in an adaptive, step-wise trial design.",[18],{"label":28,"type":10,"description":29,"interventionNames":30},"Aim 2: Sub-study 3 Optimized DAILY Dose of an mTOR inhibitor","Based on the findings from Aim 1, the optimal drug (RAPA or EVERO) and dose for DAILY delivery will be tested in a blinded placebo-controlled trial in older human subjects. The drug\u002Fdose used in males may differ from the one used in females as the OD will be determined independently for the two sexes. PD parameters 'downstream' from mTOR will be followed.",[13,18],{"label":32,"type":10,"description":33,"interventionNames":34},"Aim 2: Sub-study 3 Optimized INTERMITTENT Dosing of an mTOR inhibitor","Based on the findings from Aim 1, the optimal drug (RAPA or EVERO), interval between doses, and dose for INTERMITTENT delivery will be tested in a blinded placebo-controlled trial in older human subjects. The drug\u002Fdose\u002Finterval used in males may differ from the one used in females as the OD will be determined independently for the two sexes. PD parameters 'downstream' from mTOR will be followed. Although drug is delivered on an intermittent schedule, subjects will be given a pill each day (either drug or placebo, as scheduled) to maintain blinding.",[13,18],{"label":36,"type":37,"description":38,"interventionNames":39},"Aim 2: Sub-study 3 Placebo control","PLACEBO_COMPARATOR","Daily administration of a placebo will be given to a cohort of older human subjects. Both males and females will be enrolled as controls.",[40],"Other: Placebo",[42,49,54],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Rapamycin","mTOR inhibitor",[9,20,28,32],[48],"RAPA",{"type":43,"name":50,"description":45,"armGroupLabels":51,"otherNames":52},"Everolimus",[15,24,28,32],[53],"EVERO",{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Placebo","Inert placebo for rapamycin or everolimus",[36],[59],"Placebo capsule",[61],{"name":62,"affiliation":5,"role":63},"Ellen Kraig, PhD","PRINCIPAL_INVESTIGATOR",[65,71],{"name":66,"role":67,"phone":68,"phoneExt":69,"email":70},"Dean L Kellogg, Jr, MD PhD","CONTACT","(210) 617 5197",null,"kelloggd@uthscsa.edu",{"name":62,"role":67,"phone":72,"phoneExt":69,"email":73},"(210) 367-3171","kraig@uthscsa.edu",[75],{"facility":5,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"RECRUITING","San Antonio","Texas","78229","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-98.49363,29.42412,{"lat":86,"lon":85},[89,92],{"name":90,"role":67,"phone":91,"phoneExt":69,"email":70},"Dean L Kellogg Jr.,, MD PhD","210-617-5197",{"name":93,"role":63,"phone":69,"phoneExt":69,"email":69},"Dean L Kellogg Jr., MD PhD",{"type":63,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":69,"oldOrganization":69},"Ellen Kraig","Professor",[98],{"name":99,"class":100},"National Institute on Aging (NIA)","NIH","100566662","early-phase-1-restor-pkpd-mtori-inhibition-in-older-adults-100566662",false,"NCT06658093","RESTOR: PK\u002FPD mTORi Inhibition in Older Adults","RESTOR [Rapamycin and Everolimus Study Towards Older Rejuvenation]: An Exploratory PK\u002FPD Study of mTOR Inhibition in Older Human Subjects","RESTOR","Inclusion Criteria:\n\nOlder Cohort Sub-study 2 (AIM 1) and Sub-study 3 (AIM 2):\n\n1. Age ≥65 to 90 years\n2. Men and women\n3. In good health with all medical problems stable.\n4. Community-dwelling\n5. Agreement to adhere to Lifestyle Considerations throughout study duration.\n6. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nOlder Cohort Sub-study 2 (AIM 1) and Sub-study 3 (AIM 2):\n\n1. Resident of nursing home or long-term care facility\n2. Subjects with diabetes or currently taking glucose lowering medications\n3. History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation); Moderate to severe valvular heart disease\n4. Active cancer or history of cancer treatment within the last 5 years\n5. Chronic inflammatory condition, autoimmune disease, or infectious processes (e.g., active tuberculosis, HIV, rheumatoid arthritis, systemic lupus erythematosus, acute or chronic hepatitis B or C)\n6. History of a coagulopathy or any medical condition requiring anticoagulation (except low dose ASA)\n7. Renal insufficiency with an estimated glomerular filtration rate of \\\u003C30ml\u002Fmin\n8. Uncontrolled hypercholesterolemia \\>350mg\u002Fdl or uncontrolled hypertriglyceridemia \\>500mg\u002Fdl\n9. Anemia or abnormal blood cell counts: hemoglobin level \\\u003C9.0g.dl; white blood count \\\u003C3500\u002Fmm3; neutrophil count \\\u003C2000\u002F mm3; platelet count \\\u003C125,000\u002Fmm3\n10. History of skin ulcers or poor wound healing\n11. Active tobacco use (within 6 months)\n12. Diagnosis of any disabling neurologic disease such as Parkinson's Disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (muscle weakness or gait disorder), severe neuropathy, diagnosis of dementia or Clox1 score less than 10 at the time of screening visit, cognitive impairment due to any reason such that the patient is unable to provide informed consent\n13. Liver disease\n14. Systemic treatment with an immunosuppressant (prednisone, etc.) within the year prior to enrollment\n15. Treatment with drugs known to affect cytochrome P450 (CYP3A4), i.e., diltiazem, erythromycin.\n16. Patients with history of recent (within 6 months) myocardial infarction or active coronary disease\n17. Patients with history of recent (within 6 months) intestinal disorders\n18. History of severe head trauma, brain injury, brain surgery, inflammation of the brain, or history of seizure disorder\n19. History of Long-Covid (PASC) within one year\n20. Acute Covid19 or Covid19 infection within the last 6 months\n21. Unwilling to forgo grapefruit juice consumption.\n22. Participation in mTORi study within the prior year. (Note: participants in AIM 1 will be excluded from participating in AIM 2 of the proposed trial.)\n23. Allergic to RAPA or EVERO\n24. Allergic to lidocaine\n25. Recreational drug use\n26. Donated blood over a two-month period prior to study initiation.\n27. Currently using cannabidiol (CBD) or tetrahydrocannabinol (THC) or any preparation contained these, or related, substances.\n28. Currently using hormone replacement or modulating therapies.",true,"ALL","65 Years","90 Years",{"count":114,"type":115},194,"ESTIMATED","INTERVENTIONAL",[118],"EARLY_PHASE1","As people get older, there are changes in their cells and tissues that may affect their ability to function. This can lead to increased death and age-associated disorders, like heart disease, cancer, and Alzheimer's disease. Studies in animal models have been able to identify drugs that slow the aging process, leading to a longer, healthier life. This study is focused on one such family of drugs, called mTOR inhibitors, and the investigators' goal is to test two of these drugs, Rapamycin (Sirolimus) and Everolimus (Afinitor), in healthy older adults to find a dose and dose timing that can be used to safely inhibit mTOR to the levels seen in young healthy persons. The investigators expect that the dose that works well in women may differ from the one that is best in men, so it is important to include both sexes in this research.",[121],"Aging",[123],"mTOR inhibitors","2026-05-27",{"date":126,"type":127},"2026-06-01","ACTUAL",{"date":129,"type":127},"2026-03-04",{"date":131,"type":115},"2028-07",{"name":5,"class":6},1]