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

January 23, 2024 updated by: AgelessRx

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
129

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60605
        • AgelessRx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rapamycin 5
Rapamycin 5 mg/week
Drug: Rapamycin
Rapamycin in 2 different dosage forms.
Other Names:
  • Sirolimus
  • Rapamune
  • Rapacan
  • Siromus
  • Raparen
  • Rapasim
  • Sirova
Experimental: Rapamycin 10
Rapamycin 10 mg/week
Drug: Rapamycin
Rapamycin in 2 different dosage forms.
Other Names:
  • Sirolimus
  • Rapamune
  • Rapacan
  • Siromus
  • Raparen
  • Rapasim
  • Sirova
Placebo Comparator: Placebo 1
Placebo once per week
Drug: Placebo
Placebo capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 month interim analysis of the data, 12 month safety profile will be established

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6 month interim analysis of the data, 12 month safety profile will be established
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
6 month interim analysis of the data, 12 month safety profile will be established
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))
6 month interim analysis of the data, 12 month safety profile will be established
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
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established
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.
6 month interim analysis of the data, 12 month safety profile will be established

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AgelessRx

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Los Angeles

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sajad Zalzala, MD, AgelessRx
  • Principal Investigator: James Watson, MD, University of California, Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALRx001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

as soon as available

IPD Sharing Access Criteria

Institutional review board (IRB) approval or at the discretion of PI/sponsor

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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