A Pilot Study on Reverse Aging (The REVERSE Study) (NCT07354620) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A Pilot Study on Reverse Aging (The REVERSE Study)
United States52 participantsStarted 2025-02-15
Plain-language summary
Aging can be defined as a time-dependent functional decline in physiological function, which may increase the vulnerability to diseases and eventually death. The question is whether aging is a normal process, or exists as an "uber-illness?" Work done by Dr Sinclair at Harvard suggests the latter. Dr. Sinclair feels people should be able to age-in-place, or even reverse age. Aging is arguably the single biggest risk factor for all acquired and chronic diseases. Delaying the aging rate by 7 years would cut the incidence of chronic disease in half! Up until know the effects of anti-aging would need longitudinal studies until death.
Now, with the advent of a 3rd generation OMIC Age clock, there is a way to assess if an intervention is changing the rate of aging and other methylation patterns associated with aging.
Who can participate
Age range
50 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:
* Subjects will be healthy and of any sex, any ethnicity, and any age from 50 to 80
* "Healthy" subjects will be defined as a real-world cohort of individuals likely to utilize such an intervention
* May be on other medications if they do not conflict with rapamycin.
* All medical conditions need to be stable and well controlled.
* Willing and able to provide informed consent
Exclusion Criteria:
* Severe illnesses, for which rapamycin may cause harm. This would not be limited to but include active neoplastic or auto-immune disease. If patients have a previous history of cancer or auto-immune disease, the risks and benefits and possible adverse reactions will be discussed at time of consent
* History of organ transplant
* Any unstable medical condition that would interfere with the study
* Hepatic impairment. Note: Patients with elevated liver enzymes and low albumin, will be further screened for hepatic impairment. Elevated liver enzymes \< 2x upper limit of normal will not be considered hepatic impairment.
* Renal impairment, indicated by a serum creatinine \> 1.4 mg/dL
* Anemia indicated by a hemoglobin \< 12 g/dL
* Platelets \< 80,000/cumm,
* ANC \< 1,000 / cumm
* Total WBC \< 3,000/cumm
* Pregnancy or breastfeeding or woman of childbearing potential with inadequate contraception
* Unstable mental illness
* A condition where rapamycin may interfere deleteriously with a medication that is taken by a potential subject
* Currently prescribed with high d…
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
1
Change in Biological Age from Baseline to End of Study based on Tru Diagnostic Tru Age OMICm Age test results.