The Role of Sirolimus in Preventing Functional Decline in Older Adults
- Conditions
- Aging
- Registration Number
- NCT05237687
- Lead Sponsor
- Irina Timofte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria:<br><br> - Patients should be adults 65-80 years<br><br> - Women who are postmenopausal* or status post-surgical sterilization only<br><br> - Competent to provide Informed Consent<br><br>Exclusion Criteria:<br><br> - Creatinine clearance <30 mL/min<br><br> - Underlying chronic liver disease<br><br> - Other investigational therapy received within 1 month prior to screening visit<br><br> - Pulmonary Arterial Hypertension (PAH), mean Pulmonary Arterial Presure(mPAP)>30 mm<br> Hg<br><br> - Extrapulmonary physiological restriction (e.g. chest wall abnormality, large pleural<br> effusion)<br><br> - Cardiovascular diseases, any of the following: Myocardial infarction within 6<br> months, planned coronary artery disease intervention , left ventricular EF <45%<br><br> - History of haemorrhagic central nervous system (CNS) event within 1 year from<br> screening visit.<br><br> - Any of the following within 3 months of screening visit :Haemoptysis or<br> haematuria;Active gastro-intestinal (GI) bleeding or GI - ulcers; Major injury<br> or surgery<br><br> - History of thrombotic event (including, DVT, PE, stroke and transient ischemic<br> attack) within 1 year from screening visit.<br><br> - Other disease that may interfere with testing procedures or in the judgment of the<br> Investigator may interfere with trial participation or may put the patient at risk<br> when participating in this trial.<br><br> - Planned major surgical procedures.<br><br> - Women who are pregnant, nursing, or who plan to become pregnant while in the trial.<br><br> - Concurrent active alcohol or drug abuse.<br><br> - Clinically significant cognitive impairment<br><br> - Functional impairment (defined by ADL status)<br><br> - Patients not able to understand or follow trial procedures
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phenotypic/functional biomarkers of aging
- Secondary Outcome Measures
Name Time Method Phenotypic/functional biomarkers of aging;Phenotypic/functional biomarkers of aging;Phenotypic/functional biomarkers of aging;Phenotypic/functional biomarkers of aging;Feasibility of collecting the laboratory biomarkers and analyzing the data regarding annual rate of decline in functional biomarkers of aging