The Role of Sirolimus in Preventing Functional Decline in Older Adults

Launched by IRINA TIMOFTE · Feb 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called sirolimus on preventing age-related decline in older adults. As we age, our bodies can face challenges that lead to chronic diseases and disabilities. Researchers believe that sirolimus might help slow down these aging processes and improve overall health in older adults. The trial aims to see if sirolimus can reduce signs of aging and potentially lower the risk of chronic diseases, such as skin cancer.

To participate in this study, you must be an adult aged 65 to 80, and women should be postmenopausal or have had surgery to prevent pregnancy. Participants will need to be able to understand the study and give their consent. However, there are some exclusions, such as serious kidney or liver issues, certain heart diseases, and recent hospitalizations. If eligible, participants can expect to receive care and monitoring throughout the trial, helping researchers learn more about how sirolimus can impact aging and health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients should be adults 65-80 years
• • Women who are postmenopausal\* or status post-surgical sterilization only
• • Competent to provide Informed Consent
• Exclusion Criteria:
• • Creatinine clearance \<30 mL/min
• • Underlying chronic liver disease
• • Other investigational therapy received within 1 month prior to screening visit
• • Pulmonary Arterial Hypertension (PAH), mean Pulmonary Arterial Presure(mPAP)\>30 mm Hg
• • Extrapulmonary physiological restriction (e.g. chest wall abnormality, large pleural effusion)
• • Cardiovascular diseases, any of the following: Myocardial infarction within 6 months, planned coronary artery disease intervention , left ventricular EF \<45%
• • History of haemorrhagic central nervous system (CNS) event within 1 year from screening visit.
• • Any of the following within 3 months of screening visit :Haemoptysis or haematuria;Active gastro-intestinal (GI) bleeding or GI - ulcers; Major injury or surgery
• • History of thrombotic event (including, DVT, PE, stroke and transient ischemic attack) within 1 year from screening visit.
• • Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.
• • Planned major surgical procedures.
• • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
• • Concurrent active alcohol or drug abuse.
• • Clinically significant cognitive impairment
• • Functional impairment (defined by ADL status)
• • Patients not able to understand or follow trial procedures