CompletedPhase 2

Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study

United States129 participantsStarted 2020-01-01

Plain-language summary

This is a randomized, placebo-controlled trial into the safety and efficacy in reducing clinical measures of aging in an older adult population.

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 50-85 * Any sex * Any ethnicity * Interest in taking Rapamycin off-label * Willing to undergo tests * Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable * Adequate cognitive function to be able to give informed consent * Technologically competent to complete web forms and perform video calls with the PI Exclusion Criteria: * Anemia - Hg \< 9.0 g/dl, Leukopenia - white blood cells (WBC) \< 3,500/mm3 , Neutropenia - absolute neutrophil count \< 2,000/mm3 , or Platelet count - platelet count \< 125,000/mm3 * Premenopausal females (due to menstruation-induced anemia, etc.) * Patients scheduled to undergo major surgery in the next 12 months * Patients undergoing or scheduled to undergo chemotherapy or any other treatment for malignancy * Patients scheduled for immunosuppressant therapy for transplant * Patients with impaired wound healing or history of a chronic open wound * Untreated dyslipidemia with LDL-c \> 190 and family history of dyslipidemia, Total cholesterol \> 350 mg/dl, or triglycerides \> 880 mg/dl. * Impaired hepatic function, including elevated alkaline Phosphatase levels, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Albumin, or T. Bili. * HIV/AIDS, chronic Lyme, Babesia, Ehrlichiosis, Anaplasmosis, or other chronic infections that require ongoing treatment or monitoring * Allergy to Rapamycin * Any form of clinically releva…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in visceral fat as measured by dual-energy x-ray absorptiometry (DXA) scan

Timeframe: 6 month interim analysis of the data, 12 month safety profile will be established

Trial details

NCT IDNCT04488601

SponsorAgelessRx

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Aging trials

Who can participate

Age range

50 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.