AgelessRx
Chicago, Illinois, 60605, United States
NCT Number: NCT04488601
This is a randomized, placebo-controlled trial into the safety and efficacy in reducing clinical measures of aging in an older adult population.
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Notify Me50 year–85 year
All sexes
Interventional
Phase 2
Chicago, Illinois, 60605, United States
A randomized, double-blind, placebo-controlled trial assessing the effects of low and high doses of intermittent Rapamycin on a weekly schedule. The researchers aim to establish a long-term safety profile, determine the long-term efficacy of Rapamycin in reducing clinical aging measures, and biochemical and physiological endpoints associated with declining health and aging in healthy older adults.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Rapamycin in 2 different dosage forms.
Other names: Sirolimus, Rapamune, Rapacan, Siromus, Raparen, Rapasim, Sirova
Placebo capsules
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Visceral fat changes from baseline as determined by DXA scan.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Changes in bone density from baseline as determined by DXA scan
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Changes in lean body mass from baseline as determined by DXA scan
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Number of patients with adverse events using standard AE reporting (FDA regulations 21CFR314.80 and 1CFR213.32(s))
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
changes in CBC from baseline
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of blood electrolytes(serum potassium, sodium, chloride, and carbon dioxide in mmol/L) compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of liver function as measured by serum globulin in g/dL compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of liver function as measured by serum bilirubin in mg/dL compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of liver function as measured by serum alkaline phosphatase, AST, and ALT in IU/L compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of renal function as measured by serum albumin in g/dL compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of renal function as measured by serum creatinine and uric acid in mg/dL compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of lipids(serum total cholesterol, triglycerides, HDL and LDL cholesterol in mg/dL) compared with the baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of fasting serum glucose in mg/dL compared with baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of fasting serum insulin in uIU/mL compared with baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of fasting serum IGF-1 in ng/mL compared with baseline at 6 and 12 months between the intervention and control group is to be analyzed.
Time frame: 6 month interim analysis of the data, 12 month safety profile will be established
Difference in the change of serum Hemoglobin A1c in % of total hemoglobin compared with baseline at 6 and 12 months between the intervention and control group is to be analyzed.
AgelessRx
Industry
Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study (PEARL): A Prospective, Double-Blind, Placebo-Controlled Trial for Rapamycin in Healthy Individuals Assessing Safety and Efficacy in Reducing Aging Effects
Acronym: PEARL
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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