Status:
RECRUITING
The Role of Sirolimus in Preventing Functional Decline in Older Adults
Lead Sponsor:
Irina Timofte
Conditions:
Aging
Eligibility:
All Genders
65-80 years
Phase:
PHASE2
Brief Summary
Aging is associated with progressive impairment of tissue and organ function, resulting in increased susceptibility to chronic disease, frailty and disability. Currently there are limited treatment op...
Eligibility Criteria
Inclusion
- Patients should be adults 65-80 years
- Women who are postmenopausal\* or status post-surgical sterilization only
- Competent to provide Informed Consent
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05237687
Start Date
January 1 2026
End Date
November 1 2027
Last Update
November 28 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390