A Pilot Study on Reverse Aging (The REVERSE Study)
Running, not enrolling · Early Phase 1
Conditions studied: Aging
In brief
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.
Key facts
- Study ID
- NCT07354620
- Run by
- The Christ Hospital
- People needed
- 52
- Starts
- 2025-02-15
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2026-01-21
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 dose CYP3A4 pathway medications such as verapamil > 240 mg; simvastatin >40 mg, lovastatin > 40 mg or atorvastatin > 40 mg daily. Poor GI motility as demonstrated by delayed gastric emptying on a radionucleotide isotope scan.
- Intercurrent severe infection at initiation of study drug
- Any and all other reasons that the investigator may determine that the participant is not suitable for study enrollment.
- History of or active eating disorders as deemed by PI.
- BMI lower than 18.5
- Any medication that may dangerously lower glucose while on the FMD. This will include insulin, sulfonylureas (glyburide; glipizide); Thiazolidenediones ( eg piogltazone; rosiglitazone); GLP1 drugs (semaglutide; tirzepatide);; DPP-4 inhibitors (eg sitagliptin; saxagliptin); Alpha -glucosidase inhibitors (acarbose; miglitol). Patients on SGLT2 inhibitors (empagliflozin; canagliflozin) and Metformin (glucophage) may be included in the study.
Where it is running
- AIM for Wellbeing — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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