mTOR Inhibitors for Aging
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether mTOR inhibitors, specifically Everolimus and Sirolimus, can slow aging and prevent chronic diseases associated with aging. The goal is to understand how these medications work in the body and their potential to improve the health of older adults. Participants will receive varying doses of these drugs to assess their effects. Individuals aged 65 or older, who live independently and can understand trial procedures, might be suitable candidates. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial requires that you do not take medications that increase or decrease sirolimus blood concentrations. If you are on such medications, you may need to stop them to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that sirolimus, a type of medication, is generally safe for healthy people. Although no serious side effects were reported, some individuals experienced more infections. This suggests that while sirolimus is usually well-tolerated, it might increase the likelihood of infections in some people.
Everolimus, a similar medication, is also considered safe. One study found it safe for older adults when used for six weeks. However, a longer study reported two deaths related to the treatment, indicating that while it is often safe, serious risks can occur with long-term use.
Both treatments are mostly safe but carry potential risks, especially with prolonged use.12345Why are researchers excited about this trial's treatments?
Researchers are excited about mTOR inhibitors like Everolimus and Sirolimus because they have the potential to target aging at the cellular level. Unlike standard treatments that may focus on symptoms or isolated age-related conditions, these drugs work by inhibiting the mTOR pathway, which is directly involved in cell growth and metabolism. This unique mechanism of action could slow down the aging process itself, offering a more holistic approach to enhancing longevity and healthspan. Additionally, both Everolimus and Sirolimus are being tested at different dosages, which might provide insights into optimizing their effectiveness and safety for anti-aging benefits.
What evidence suggests that this trial's treatments could be effective for aging?
Research suggests that drugs like sirolimus and everolimus, both studied in this trial, might help slow aging. Sirolimus has reduced signs of aging in cells, but limited data exists on its effects in people. Everolimus is generally safe for older adults and might aid aging by blocking certain cellular processes. Although more studies on human aging are needed, both treatments show promise by targeting mechanisms related to aging. Researchers are exploring these treatments for their potential to extend a healthy lifespan.16789
Who Is on the Research Team?
Irina Timofte, MD, MS
Principal Investigator
UT Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for community-dwelling adults aged 65 and older who can understand and follow the trial procedures. It aims to explore how certain medications might affect aging, but details on exclusion criteria are not provided.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mTOR inhibitors (sirolimus or everolimus) to assess pharmacokinetics and pharmacodynamics
Follow-up
Participants are monitored for changes in phenotypic biomarkers of aging and safety
What Are the Treatments Tested in This Trial?
Interventions
- Everolimus
- Sirolimus
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
University of Maryland, Baltimore
Collaborator
National Institute on Aging (NIA)
Collaborator