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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions

Summary

This trial is testing Rapamycin, a drug that might help slow down aging. It focuses on healthy older adults to see if the drug can reduce signs of aging and improve health. The drug works by potentially influencing how cells function and age.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in visceral fat as measured by dual-energy x-ray absorptiometry (DXA) scan
Secondary study objectives
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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
6 Previous Clinical Trials
148 Total Patients Enrolled
2 Trials studying Aging
67 Patients Enrolled for Aging
University of California, Los AngelesOTHER
1,564 Previous Clinical Trials
10,262,504 Total Patients Enrolled
6 Trials studying Aging
633 Patients Enrolled for Aging
James Watson, MDPrincipal InvestigatorUniversity of California, Los Angeles

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
~22 spots leftby Nov 2025
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