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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month interim analysis of the data, 12 month safety profile will be established
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month interim analysis of the data, 12 month safety profile will be established
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 moreSide effects data
From 2009 Phase 4 trial • 20 Patients • NCT0022367831%
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
1,538 Previous Clinical Trials
10,266,902 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- People of any gender can participate.People of any race or ethnic background can participate.You are currently receiving or planning to receive chemotherapy or other cancer treatments.You have a chronic open wound or problems with healing wounds.You have Type I diabetes or Type II diabetes that requires insulin for treatment.You have struggled with drug or alcohol addiction that has not been treated or was treated within the last 5 years.You have fibromyalgia, chronic fatigue syndrome/myalgic encephalomyelitis, or breast implant illness.You have untreated or poorly controlled mental health conditions like PTSD, bipolar disorder, schizophrenia, or other mood disorders. You have also been hospitalized in the past for mental health reasons.You are not interested in trying Rapamycin for a purpose other than what it is approved for.
Research Study Groups:
This trial has the following groups:- Group 1: Rapamycin 10
- Group 2: Placebo 1
- Group 3: Rapamycin 5
Awards:
This trial has 2 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Aging Patient Testimony for trial: Trial Name: NCT04488601 — Phase 2
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