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AgingPhase 2PEARLNCT04488601

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

A Phase 2 study testing Rapamycin in people with Aging, run by AgelessRx at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Rapamycin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
129 participants
Where
1 siteUnited States
Study dates
1 Jan 2020to 30 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AgelessRx

    Chicago, Illinois, 60605

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Aging
Being tested
Rapamycin, Placebo
Keywords
rapamycin, aging, longevity, sirolimus, healthy aging, age-related conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RapamycinDrug

    Also called Sirolimus, Rapamune, Rapacan, Siromus

    Rapamycin in 2 different dosage forms.

  • PlaceboDrug

    Placebo capsules

Study groups in NCT04488601
Study groupRoleWhat they receive
Rapamycin 5ExperimentalRapamycin 5 mg/week
Receives: Drug: Rapamycin
Rapamycin 10ExperimentalRapamycin 10 mg/week
Receives: Drug: Rapamycin
Placebo 1Placebo comparatorPlacebo once per week
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Visceral fat changes from baseline as determined by DXA scan.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

Secondary outcomes (15)

  1. bone density

    Changes in bone density from baseline as determined by DXA scan

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  2. lean body mass

    Changes in lean body mass from baseline as determined by DXA scan

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  3. adverse events

    Number of patients with adverse events using standard AE reporting (FDA regulations 21CFR314.80 and 1CFR213.32(s))

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  4. complete blood count (CBC)

    changes in CBC from baseline

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  5. Change of blood electrolytes（serum potassium, sodium, chloride, and carbon dioxide in mmol/L）measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  6. Change of liver function as measured by serum globulin in g/dL, measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  7. Change of liver function as measured by serum bilirubin in mg/dL, measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  8. 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.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  9. Change of renal function as measured by serum albumin in g/dL, measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  10. Change of renal function as measured by serum creatinine and uric acid in mg/dL, measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  11. Change in lipids (serum total cholesterol, triglycerides, HDL, and LDL cholesterol in mg/dL) measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  12. Change in fasting serum glucose in mg/dL, measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  13. Change in insulin in uIU/mL, measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  14. Change in fasting serum IGF-1 in ng/mL, measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

  15. Change in serum Hemoglobin A1c in % of total hemoglobin, measured at baseline and after 6 and 12 months.

    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.

    Measured: 6 month interim analysis of the data, 12 month safety profile will be established

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2020
  2. Study start1 Jan 2020
  3. Primary completion30 Dec 2023
  4. Study completion30 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, Double-Blind, Placebo-Controlled Trial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04488601
Sponsor's protocol ID
ALRx001
Acronym
PEARL
Status last verified
Oct 2022
First submitted
13 Jul 2020
Last updated
24 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rapamycin in people with Aging, run by AgelessRx at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04488601.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.

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PEARL Clinical Trial NCT04488601 | AzTrials