Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:01 AM
Study NCT ID:
NCT07354620
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2025-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study on Reverse Aging (The REVERSE Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2025-12-11', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Biological Age from Baseline to End of Study based on Tru Diagnostic Tru Age OMICm Age test results.', 'timeFrame': '24 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': '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.', 'timeFrame': '24 weeks', 'description': '. This will duplicate studies already done utilizing a 5 day Fasting Mimicking Diet (FMD) (Prolon) on aging. The FMD diet will be administered 6 times - at monthly intervals. Change in OMICm methylation from baseline to Week 24'}, {'measure': 'Effect of weekly low-dose rapamycin on aging based on Tru Diagnostic Tru Age OMICm Age test results.', 'timeFrame': '24 weeks', 'description': 'Change in OMICm methylation from baseline to Week 24'}, {'measure': 'Lowering of insulin resistance based on Tru Diagnostic Tru Age OMICm Age test results.', 'timeFrame': '24 weeks', 'description': 'To evaluate the combined effects of AMPK and low-dose weekly rapamycin, at lowering insulin resistance, and thereby PI3K (PI3 kinase).'}, {'measure': 'Effects on insulin resistance', 'timeFrame': '24 weeks', 'description': 'To stratify outcomes of the prior three outcomes based on insulin resistance. This will be monitored using a Quest Lab Insulin Resistance panel to determine if insulin resistance is a confounding variable from any of the above. Variability of results in a, b, or c based on high, low or moderate insulin resistance.'}, {'measure': 'Does reversal of age improve cognition based on the Cognitive Flexibility Inventory.', 'timeFrame': '24 weeks', 'description': 'Changes in the Cognitive Flexibility Inventory from baseline to week 24. Scores range from 20-140, with a higher score representing a better outcome.'}, {'measure': 'Patterns based on Age based on Tru Diagnostic Tru Age OMICm Age test results.', 'timeFrame': '24 weeks', 'description': 'To see if any pattern exists within age group categories. (50-65; older than age 65). Change in OMICm methylation results from baseline to Week 24 by two sub populations: ages 50-65 and ages older than age 65'}, {'measure': 'Sex Difference based on Tru Diagnostic Tru Age OMICm Age test results.', 'timeFrame': '24 weeks', 'description': 'Change in OMICm methylation from baseline to Week 24 by male vs female'}, {'measure': 'Safety and tolerability of rapamycin and Prolon', 'timeFrame': '28 weeks', 'description': 'Review of adverse reactions from baseline to Week 28'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aging', 'Reverse Aging', 'Rapamycin', 'Biological Age', 'Chronological Age', 'Prolon'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': '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.\n\nNow, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects will be healthy and of any sex, any ethnicity, and any age from 50 to 80\n* "Healthy" subjects will be defined as a real-world cohort of individuals likely to utilize such an intervention\n* May be on other medications if they do not conflict with rapamycin.\n* All medical conditions need to be stable and well controlled.\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* 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\n* History of organ transplant\n* Any unstable medical condition that would interfere with the study\n* 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.\n* Renal impairment, indicated by a serum creatinine \\> 1.4 mg/dL\n* Anemia indicated by a hemoglobin \\< 12 g/dL\n* Platelets \\< 80,000/cumm,\n* ANC \\< 1,000 / cumm\n* Total WBC \\< 3,000/cumm\n* Pregnancy or breastfeeding or woman of childbearing potential with inadequate contraception\n* Unstable mental illness\n* A condition where rapamycin may interfere deleteriously with a medication that is taken by a potential subject\n* 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.\n* Intercurrent severe infection at initiation of study drug\n* Any and all other reasons that the investigator may determine that the participant is not suitable for study enrollment.\n* History of or active eating disorders as deemed by PI.\n* BMI lower than 18.5\n* 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.'}, 'identificationModule': {'nctId': 'NCT07354620', 'briefTitle': 'A Pilot Study on Reverse Aging (The REVERSE Study)', 'organization': {'class': 'OTHER', 'fullName': 'The Christ Hospital'}, 'officialTitle': 'A Pilot Study on Reverse Aging (The REVERSE Study)', 'orgStudyIdInfo': {'id': '24-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rapamycin Only', 'description': '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', 'interventionNames': ['Drug: Rapamycin (Tablets)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Prolon Diet Only', 'description': '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;', 'interventionNames': ['Dietary Supplement: Prolon diet']}, {'type': 'EXPERIMENTAL', 'label': 'Rapamycin and Prolon Diet', 'description': '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.', 'interventionNames': ['Drug: Rapamycin (Tablets)', 'Dietary Supplement: Prolon diet']}], 'interventions': [{'name': 'Rapamycin (Tablets)', 'type': 'DRUG', 'description': '10 mg initial bolus dose of rapamycin followed by a weekly 6 mg rapamycin', 'armGroupLabels': ['Rapamycin Only', 'Rapamycin and Prolon Diet']}, {'name': 'Prolon diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Prolon 5-day diet at 0, 1, 2, 3, 4,and 5 months', 'armGroupLabels': ['Prolon Diet Only', 'Rapamycin and Prolon Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'AIM for Wellbeing', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Christ Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Steve Amoils', 'investigatorAffiliation': 'The Christ Hospital'}}}}