60 Participants Needed

mTOR Inhibitors for Aging

IT
Overseen ByIrina Timofte, MD, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

IT

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

I live in my own home or with family.
I am 65 years old or older.
I can understand and follow the trial's instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mTOR inhibitors (sirolimus or everolimus) to assess pharmacokinetics and pharmacodynamics

3 months
Multiple visits for blood sampling and biomarker assessment

Follow-up

Participants are monitored for changes in phenotypic biomarkers of aging and safety

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Everolimus
  • Sirolimus
Trial Overview The study tests different doses of mTOR inhibitors (Sirolimus and Everolimus) in tablet form to gather data on their effects in older adults. This could lay the groundwork for future trials on slowing aging processes.
How Is the Trial Designed?
6Treatment groups
Active Control
Group I: sirolimus 0.5 mg ArmActive Control1 Intervention
Group II: sirolimus 1 mg ArmActive Control1 Intervention
Group III: everolimus 0.5 mg ArmActive Control1 Intervention
Group IV: everolimus 2 mg ArmActive Control1 Intervention
Group V: sirolimus 2 mg ArmActive Control1 Intervention
Group VI: everolimus 1 mg ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

University of Maryland, Baltimore

Collaborator

Trials
729
Recruited
540,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/22297244/
Efficacy and safety of everolimus in elderly patients with ...Everolimus was generally well tolerated in elderly patients, and most adverse events were grade 1 or 2 in severity.
Study Details | NCT05835999 | Everolimus Aging StudyThe objective of this project is to determine if mTORC1 inhibition by 24 weeks of daily (0.5 mg/day) or weekly (5 mg/week) everolimus can safely improve ...
Efficacy and Safety of Everolimus in Elderly Patients With ...Everolimus is effective and tolerable in elderly patients with mRCC. When selecting targeted therapies in these patients, the specific toxicity profile of each ...
Everolimus for Aging (EVERLAST Trial)Early findings suggest that by blocking mTORC1, everolimus might improve signs of aging in humans. Although more research is needed specifically on aging, these ...
Novartis drug Afinitor® significantly improves progression ...In pivotal study, everolimus reduced risk of disease progression by 52%; showed 11.0-month median progression-free survival vs 3.9 months ...
Effect of rapamycin on aging and age-related diseases—past ...As noted above, Mannick et al. [97] found that the rapalog, RAD001, was safe when given to subjects ≥ 65 years of age for 6 weeks; the RAD001-treated group ...
Rapamycin for longevity: the pros, the cons, and future ...Everolimus significantly reduced seizure frequency, with approximately 40% of patients in the high-dose group achieving a ≥50% reduction in ...
What is the clinical evidence to support off-label rapamycin ...Despite the preclinical evidence supporting the use of sirolimus to enhance mean and maximal lifespan, the data in humans have yet to establish ...
Targeting ageing with rapamycin and its derivatives in ...reported a tolerable safety profile and no deaths; however, the subsequent extended phase (48 weeks) of the same study reported two treatment-related deaths ...
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