Actively Recruiting
RESTOR: PK/PD mTORi Inhibition in Older Adults
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-09-04
194
Participants Needed
1
Research Sites
150 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
As people get older, there are changes in their cells and tissues that may affect their ability to function. This can lead to increased death and age-associated disorders, like heart disease, cancer, and Alzheimer's disease. Studies in animal models have been able to identify drugs that slow the aging process, leading to a longer, healthier life. This study is focused on one such family of drugs, called mTOR inhibitors, and the investigators' goal is to test two of these drugs, Rapamycin (Sirolimus) and Everolimus (Afinitor), in healthy older adults to find a dose and dose timing that can be used to safely inhibit mTOR to the levels seen in young healthy persons. The investigators expect that the dose that works well in women may differ from the one that is best in men, so it is important to include both sexes in this research.
CONDITIONS
Official Title
RESTOR: PK/PD mTORi Inhibition in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 to 90 years
- Men and women
- In good health with all medical problems stable
- Community-dwelling
- Agree to follow lifestyle considerations during the study
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Living in a nursing home or long-term care facility
- Having diabetes or taking glucose-lowering medications
- History of moderate to severe heart or lung disease
- Active cancer or cancer treatment within past 5 years
- Chronic inflammatory or autoimmune diseases, or infectious conditions like active tuberculosis or HIV
- History of blood clotting disorders or requiring blood thinners (except low-dose aspirin)
- Severe kidney problems (glomerular filtration rate less than 30 ml/min)
- Uncontrolled high cholesterol or triglycerides
- Anemia or abnormal blood cell counts
- History of skin ulcers or poor wound healing
- Active tobacco use within 6 months
- Disabling neurological diseases or cognitive impairment affecting consent ability
- Liver disease
- Systemic immunosuppressant treatment within past year
- Treatment with drugs affecting cytochrome P450 (CYP3A4)
- Recent heart attack or active coronary disease within 6 months
- Recent intestinal disorders within 6 months
- History of severe brain injury, inflammation, or seizures
- History of Long-Covid within one year
- Covid-19 infection within last 6 months
- Unwillingness to avoid grapefruit juice
- Participation in mTOR inhibitor study within prior year
- Allergies to Rapamycin, Everolimus, or lidocaine
- Recreational drug use
- Recent blood donation within 2 months
- Current use of cannabidiol (CBD), tetrahydrocannabinol (THC), or related substances
- Current hormone replacement or modulating therapies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
D
Dean L Kellogg, Jr, MD PhD
CONTACT
E
Ellen Kraig, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
7
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