Effect of mTOR Inhibition & Other Metabolism Modulating Interventions on the Elderly [SubStudy Rapa & cMRI to Evaluate Cardiac Function]

NCT04742777 | Completed Phase 2 DMC FDA Drug

• 2 other identifiers: HSC20120304H (Addendum)5P30AG044271-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The ability to mount an effective immune response declines with age, leaving the elderly increasingly susceptible to infectious diseases and cancer. Rapamycin, an FDA approved drug to prevent transplant rejection, increases the lifespan and healthspan of mice and ameliorates age-related declines in immune responsiveness, cancer survival, and cognition in laboratory animals. Investigators are conducting a translational trial to test whether rapamycin also improves life functions in humans focusing on elderly persons (aged 70-95). Substudy E will evaluate the Rapamycin and Cardiac Function.

Conditions

Aging

Keywords

geriatrics

Outcome Measures

Primary Outcomes (4)

• Systolic Function

  Test whether RAPA improves systolic function in elderly subjects. Cardiac MRI will be measured before and after 8 weeks of RAPA administration using 3T MRI. From collected MRI data, the study team will quantify change in systolic volumes.

  Baseline to 8 weeks

• Diastolic Function

  Test whether RAPA improves diastolic function in elderly subjects.Cardiac MRI will be measured before and after 8 weeks of RAPA administration using 3T MRI. From collected MRI data, the study team will quantify change in diastolic volumes.

  Baseline to 8 weeks

• Aortic Cross-Sectional Area

  Test whether RAPA increases aortic compliance in elderly subjects. Aortic MRI will be measured before and after 8 weeks of RAPA using 3T MRI. The study team will quantify distal descending aortic cross-sectional area to assess aortic function/compliance effects.

  Baseline to 8 weeks

• Aortic Distensibility

  Test whether RAPA increases aortic compliance in elderly subjects. Aortic MRI will be measured before and after 8 weeks of RAPA using 3T MRI. The study team will quantify change in distal descending aortic distensibility to assess aortic function/compliance effects.

  Baseline to 8 weeks

Study Arms (1)

Rapamycin

EXPERIMENTAL

Rapamycin 1mg for 8 weeks

Drug: rapamycin

Interventions

rapamycin DRUG

Taken orally 1mg daily for 8 weeks

Also known as: Sirolimus

Rapamycin

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• men and women 70-95 years of age.
• Subjects will be in good general health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable. Selected subjects will be in good health (Per the World Health Organization good health will be defined as complete physical, mental, and social well-being and not merely the absence of disease or infirmity.
• For our purposes all diseases or infirmities will be clinically stable whether managed by medications or not.
• All ethnicities will be included.
• For cardiac and brain imaging by MRI, a pre-MRI screening questionnaire will be used to assess MRI safety and neurological health.

You may not qualify if:

• Diabetes, (with A1c ≥6.5 or if treated with medication affecting glucose homeostasis History of skin ulcers or poor wound healing,
• Smoking,
• Liver disease,
• Anti-coagulation,
• Treatment with drugs known to affect cytochrome P450 3A (diltiazem, erythromycin, etc) due to its role in RAPA metabolism,
• Treatment (\>30days of therapy or long term) with a systemic immunosuppressant (prednisone, etc.) within the last year,
• History of recent (within 6 months) Myocardial Infarction or active Coronary Disease,
• Patients with history of recent (within 6 months) intestinal disorders,
• Positive COVID19 test.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• The Claude D. Pepper Older Americans Independence Centers: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (2)

Audie L. Murphy Memorial Veterans Hospital

San Antonio, Texas, 78229, United States

Location

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Dean L Kellogg, Jr., MD PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Rapamycin 1mg for 8 weeks

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 8, 2021
• Study Start: February 1, 2022
• Primary Completion: September 9, 2025
• Study Completion: September 9, 2025
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will become available at study completion at the time of journal publication.

Locations

US (2)