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Rapamycin for Aging (PEARL Trial)

Phase 2
Waitlist Available
Led By James Watson, MD
Research Sponsored by AgelessRx
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month interim analysis of the data, 12 month safety profile will be established
Awards & highlights

PEARL Trial Summary

This trial is testing whether a drug is safe and effective at reducing signs of aging in older adults.

PEARL Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month interim analysis of the data, 12 month safety profile will be established
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month interim analysis of the data, 12 month safety profile will be established for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in visceral fat as measured by dual-energy x-ray absorptiometry (DXA) scan
Secondary outcome measures
Change in fasting serum IGF-1 in ng/mL, measured at baseline and after 6 and 12 months.
Change in fasting serum glucose in mg/dL, measured at baseline and after 6 and 12 months.
Change in insulin in uIU/mL, measured at baseline and after 6 and 12 months.
+12 more

Side effects data

From 2009 Phase 4 trial • 20 Patients • NCT00223678
31%
pneumonia
15%
acute kidney failure
8%
dehydration
8%
hip replacement
8%
acute rejection
8%
total abdominal hysterectomy and salpingectomy
8%
anemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rapamycin Group
CNI Group

PEARL Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Rapamycin 5Experimental Treatment1 Intervention
Rapamycin 5 mg/week
Group II: Rapamycin 10Experimental Treatment1 Intervention
Rapamycin 10 mg/week
Group III: Placebo 1Placebo Group1 Intervention
Placebo once per week
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved

Find a Location

Who is running the clinical trial?

AgelessRxLead Sponsor
5 Previous Clinical Trials
2,571 Total Patients Enrolled
1 Trials studying Aging
2,500 Patients Enrolled for Aging
University of California, Los AngelesOTHER
1,528 Previous Clinical Trials
10,276,722 Total Patients Enrolled
6 Trials studying Aging
658 Patients Enrolled for Aging
Sajad Zalzala, MDStudy DirectorAgelessRx
4 Previous Clinical Trials
2,556 Total Patients Enrolled
1 Trials studying Aging
2,500 Patients Enrolled for Aging

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04488601 — Phase 2
Aging Research Study Groups: Rapamycin 10, Placebo 1, Rapamycin 5
Aging Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04488601 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04488601 — Phase 2
Aging Patient Testimony for trial: Trial Name: NCT04488601 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age threshold for this clinical experiment limited to those over seventy-five years old?

"This clinical trial seeks patients that fulfill the criteria of being between 50 and 85 years old. On the other hand, there are 55 trials for people aged below 18 and 334 research studies available for those above 65."

Answered by AI

Am I eligible to become involved in this research initiative?

"Qualified patients are aged between 50 and 85, with the trial looking to enrol approximately 150 applicants."

Answered by AI

What conditions are typically addressed with Rapamycin?

"Rapamycin is a popular intervention for organ transplant rejection, liver disease, and kidney conditions such as renal angiomyolipomas."

Answered by AI

How many participants have enrolled in the clinical trial?

"Unfortunately, this research study is not currently enrolling participants. It was initially posted on January 1st 2020 and last updated on October 3rd 2022. If you're looking for further studies, there are 245 medical trials related to aging that have open enrolment slots and 125 studies regarding Rapamycin which are actively searching for individuals."

Answered by AI

Have any past investigations explored the efficacy of Rapamycin?

"At the moment, 125 trials are being administered for Rapamycin. 13 of those initiatives have reached Phase 3 development and many are based in Cincinnati, Ohio with a total of 1074 experiment sites across the world."

Answered by AI

Is there room for additional participants in this experiment?

"At present, this clinical investigation is not enrolling new participants. It was initially listed on the 1st of January 2020 and last modified on October 3rd 2022. If you are seeking other studies to participate in, there are 245 trials related to aging that are actively recruiting as well as 125 for Rapamycin."

Answered by AI

How hazardous can Rapamycin be for those receiving it as therapy?

"With respect to safety, rapamycin was rated a 2 on a scale of 1-3 since it is currently in the second phase of clinical trials and evidence has been collected that supports its security but not necessarily efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
Texas
Other
Illinois
How old are they?
18 - 65
65+
What site did they apply to?
AgelessRx
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
2

Why did patients apply to this trial?

I am using a medication for melasma, is this a problem for you? Interested in antiaging, longevity high functioning individual that doesn't want to have any decrease in my performance do to aging.
PatientReceived 2+ prior treatments
~25 spots leftby Apr 2025