Using Sirolimus to Prevent Functional Decline in Older Adults

Sirolimus in Older Adults- Randomized Trial Assessing the Improvement in Phenotypic/Functional Biomarkers of Aging

This study is testing if the drug sirolimus can help older adults aged 65 to 80 stay healthier and maintain their daily activities as they age.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 65 Years to 80 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT05237687 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of sirolimus, an immunosuppressive drug, to prevent functional decline associated with aging in adults aged 65 to 80. The study aims to explore how sirolimus affects the mTOR signaling pathway, which is linked to various age-related diseases and conditions. By targeting this pathway, the trial seeks to identify a new therapeutic intervention that could mitigate the degenerative processes of aging. Participants will be closely monitored for changes in their functional abilities and overall health.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 65 to 80 who are competent to provide informed consent and meet specific health criteria.

Not a fit: Patients with severe renal impairment, chronic liver disease, or significant cardiovascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life for older adults by slowing down the aging process and reducing the risk of chronic diseases.

How similar studies have performed: While the use of sirolimus in aging is a novel approach, previous studies have shown promise in targeting the mTOR pathway for various diseases, suggesting potential for success.

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

Where this trial is running

Dallas, Texas

• UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Irina Timofte, M.D. — University of Texas Southwestern Medical Center
• Study coordinator: Irina Timofte

Conditions: Aging, aging, sirolimus, prevention