RESTOR: PK/PD mTORi Inhibition in Older Adults

ConditionAging
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age65-90
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

Qualifiers

Age ≥65 to 90 years

Men and women

In good health with all medical problems stable.

Community-dwelling

Disqualifiers

Resident of nursing home or long-term care facility

Subjects with diabetes or currently taking glucose lowering medications

History of moderate-severe heart disease (New York Heart Classification greater than grade II) or pulmonary disease (dyspnea on exertion upon climbing one flight of stairs or less; abnormal breath sounds on auscultation); Moderate to severe valvular heart disease

Active cancer or history of cancer treatment within the last 5 years

Trial design

Treatments tested in this trial

  • Rapamycin
  • Everolimus
  • Placebo

Treatment groups

194 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Sponsors and collaborators