Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study (PEARL)

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ClinicalTrials.gov Identifier: NCT04488601

Recruitment Status : Completed

First Posted : July 28, 2020

Last Update Posted : January 24, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborator:

University of California, Los Angeles

Information provided by (Responsible Party):

AgelessRx

Tracking Information

First Submitted Date ^ICMJE

July 13, 2020

First Posted Date ^ICMJE

July 28, 2020

Last Update Posted Date

January 24, 2024

Actual Study Start Date ^ICMJE

January 1, 2020

Actual Primary Completion Date

December 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in visceral fat as measured by dual-energy x-ray absorptiometry (DXA) scan [ 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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

bone density [ 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
lean body mass [ 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
adverse events [ 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))
complete blood count (CBC) [ Time Frame: 6 month interim analysis of the data, 12 month safety profile will be established ]
changes in CBC from baseline
Change of blood electrolytes（serum potassium, sodium, chloride, and carbon dioxide in mmol/L）measured at baseline and after 6 and 12 months. [ 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.
Change of liver function as measured by serum globulin in g/dL, measured at baseline and after 6 and 12 months. [ 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.
Change of liver function as measured by serum bilirubin in mg/dL, measured at baseline and after 6 and 12 months. [ 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.
Change of liver function as measured by serum alkaline phosphatase, AST, and ALT in IU/L, measured at baseline and after 6 and 12 months. [ 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.
Change of renal function as measured by serum albumin in g/dL, measured at baseline and after 6 and 12 months. [ 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.
Change of renal function as measured by serum creatinine and uric acid in mg/dL, measured at baseline and after 6 and 12 months. [ 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.
Change in lipids (serum total cholesterol, triglycerides, HDL, and LDL cholesterol in mg/dL) measured at baseline and after 6 and 12 months. [ 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.
Change in fasting serum glucose in mg/dL, measured at baseline and after 6 and 12 months. [ 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.
Change in insulin in uIU/mL, measured at baseline and after 6 and 12 months. [ 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.
Change in fasting serum IGF-1 in ng/mL, measured at baseline and after 6 and 12 months. [ 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.
Change in serum Hemoglobin A1c in % of total hemoglobin, measured at baseline and after 6 and 12 months. [ 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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Participatory Evaluation (of) Aging (With) Rapamycin (for) Longevity Study

Official Title ^ICMJE

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

Brief Summary

This is a randomized, placebo-controlled trial into the safety and efficacy in reducing clinical measures of aging in an older adult population.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective, Double-Blind, Placebo-Controlled Trial

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Aging

Intervention ^ICMJE

Drug: Rapamycin
Rapamycin in 2 different dosage forms.
Other Names:
- Sirolimus
- Rapamune
- Rapacan
- Siromus
- Raparen
- Rapasim
- Sirova
Drug: Placebo
Placebo capsules

Study Arms ^ICMJE

Experimental: Rapamycin 5
Rapamycin 5 mg/week

Intervention: Drug: Rapamycin
Experimental: Rapamycin 10
Rapamycin 10 mg/week

Intervention: Drug: Rapamycin
Placebo Comparator: Placebo 1
Placebo once per week

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

129

Original Estimated Enrollment ^ICMJE

1000

Actual Study Completion Date ^ICMJE

December 30, 2023

Actual Primary Completion Date

December 30, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Age 50-85
Any sex
Any ethnicity
Interest in taking Rapamycin off-label
Willing to undergo tests
Relatively good health with only well-managed chronic diseases (hypertension, coronary artery disease, type II diabetes, etc.) clinically stable
Adequate cognitive function to be able to give informed consent
Technologically competent to complete web forms and perform video calls with the PI

Exclusion Criteria:

Anemia - Hg < 9.0 g/dl, Leukopenia - white blood cells (WBC) < 3,500/mm3 , Neutropenia - absolute neutrophil count < 2,000/mm3 , or Platelet count - platelet count < 125,000/mm3
Premenopausal females (due to menstruation-induced anemia, etc.)
Patients scheduled to undergo major surgery in the next 12 months
Patients undergoing or scheduled to undergo chemotherapy or any other treatment for malignancy
Patients scheduled for immunosuppressant therapy for transplant
Patients with impaired wound healing or history of a chronic open wound
Untreated dyslipidemia with LDL-c > 190 and family history of dyslipidemia, Total cholesterol > 350 mg/dl, or triglycerides > 880 mg/dl.
Impaired hepatic function, including elevated alkaline Phosphatase levels, aspartate aminotransferase (AST), alanine aminotransferase (ALT), Albumin, or T. Bili.
HIV/AIDS, chronic Lyme, Babesia, Ehrlichiosis, Anaplasmosis, or other chronic infections that require ongoing treatment or monitoring
Allergy to Rapamycin
Any form of clinically relevant primary or secondary immune dysfunction or deficiency (e.g. X-linked agammaglobulinemia (XLA), common variable immunodeficiency (CVID))
Chronic oral corticosteroid or immunosuppressive medication use (e.g. Enbrel, Humira, methotrexate).
Fibromyalgia or Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, Breast Implant Illness,
Congestive heart failure: self-assessed functional status of heart failure New York Heart Association (NYHA) classification III or IV
Impaired renal function, as defined as glomerular filtration rate (GFR) < 30
Poorly controlled diabetes, as defined as HbA1c > 7%
Type I Diabetes, or Insulin-dependent Type II diabetes
Substance abuse disorder either untreated or if treated within the last 5 years
PTSD, Bipolar disorder, Schizophrenia, or any other untreated or poorly controlled mental health or mood disorder, or history of hospitalization due to mental health condition
Those who have taken metformin, rapamycin, or rapalogs in the past 6 months
- (volunteers who were on metformin for aging can participate, provided they agree to stop taking metformin before and during the trial)

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

50 Years to 85 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04488601

Other Study ID Numbers ^ICMJE

ALRx001

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

IPD Sharing Statement ^ICMJE

Plan to Share IPD:	Yes
Supporting Materials:	Study Protocol
Supporting Materials:	Statistical Analysis Plan (SAP)
Supporting Materials:	Informed Consent Form (ICF)
Supporting Materials:	Clinical Study Report (CSR)
Supporting Materials:	Analytic Code
Time Frame:	as soon as available
Access Criteria:	Institutional review board (IRB) approval or at the discretion of PI/sponsor