A Pilot Study on Reverse Aging (The REVERSE Study)

NCT07354620 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: 24-088
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aging

Keywords

Aging; Reverse Aging; Rapamycin; Biological Age; Chronological Age; Prolon

Outcome Measures

Primary Outcomes (1)

• Change in Biological Age from Baseline to End of Study based on Tru Diagnostic Tru Age OMICm Age test results.

  To evaluate the gradated effects of mTOR inhibition on a new OMIC methylation test that evaluates biological (vs chronological) age over a six-month period.

  24 weeks

Secondary Outcomes (8)

• To evaluate the effects of AMPK (AMP Kinase inhibition) on aging. Change in OMICm methylation from baseline to Week 24 based on Tru Diagnostic Tru Age OMICm Age test results.

  24 weeks

• Effect of weekly low-dose rapamycin on aging based on Tru Diagnostic Tru Age OMICm Age test results.

  24 weeks

• Lowering of insulin resistance based on Tru Diagnostic Tru Age OMICm Age test results.

  24 weeks

• Effects on insulin resistance

  24 weeks

• Does reversal of age improve cognition based on the Cognitive Flexibility Inventory.

  24 weeks

Study Arms (3)

Rapamycin Only

EXPERIMENTAL

12 participants: 10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin, enrolling 6 men, 6 women, with 6 ( 3 M, 3 F) who are 50-65 years; 6 ( 3 M, 3 F) who are \>65 years

Drug: Rapamycin (Tablets)

Prolon Diet Only

ACTIVE COMPARATOR

12 participants: 6 men, 6 women, with 6 (3 M, 3 F) who are 50-65 years; 6 who are \>65 years Prolon® 5-day diet at 0, 1, 2, 3, 4 and 5 months;

Dietary Supplement: Prolon diet

Rapamycin and Prolon Diet

EXPERIMENTAL

24 participants: 10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin along with Prolon 5-day diet at 0, 1, 2, 3, 4,and 5 months. : 12 men, 12 women, 12 ( 6 M, 6 F) who are 50-65 years; 12 ( 6 M, 6 F) who are \>65 years.

Drug: Rapamycin (Tablets); Dietary Supplement: Prolon diet

Interventions

Rapamycin (Tablets) DRUG

10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin

Rapamycin Only; Rapamycin and Prolon Diet

Prolon diet DIETARY_SUPPLEMENT

Prolon 5-day diet at 0, 1, 2, 3, 4,and 5 months

Prolon Diet Only; Rapamycin and Prolon Diet

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• The Christ Hospital: lead

Study Sites (1)

AIM for Wellbeing

Cincinnati, Ohio, 45236, United States

Location

MeSH Terms

Interventions

Sirolimus; Tablets

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 21, 2026
• Study Start: February 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)