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mTOR Inhibitor
Rapalogs for Aging
Phase 1
Recruiting
Led By Adam Konopka, PhD
Research Sponsored by University of Wisconsin, Madison
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 through study completion, an average 3 years
Awards & highlights
Study Summary
This trial seeks to find a safe, effective weekly dose of two drugs to treat aging in people aged 55-80 who don't have chronic diseases. Study lasts up to 17 weeks, with participants taking either sirolimus or everolimus weekly.
Who is the study for?
The RAP PAC study is for adults aged 55-80 without chronic diseases, willing to follow the study's procedures for up to 17 weeks. Participants must have good organ function, not be on certain medications or have specific health conditions, and males must use contraception during the study.Check my eligibility
What is being tested?
This trial tests weekly doses of mTOR inhibitors sirolimus and everolimus (5 mg, 10 mg, or 15 mg) over a period of six weeks to see if they can positively affect aging biology. The trial will first complete testing with everolimus followed by sirolimus.See study design
What are the potential side effects?
Potential side effects may include mouth sores or ulcers due to stomatitis, increased risk of infections from lowered immunity, possible changes in blood cell counts leading to anemia or bleeding issues, and interactions with other drugs affecting liver enzymes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose Limited Toxicities (DLTs)
Secondary outcome measures
Change in concentration of lipid species
Change in concentration of metabollites
Change in glucose tolerance
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: SirolimusExperimental Treatment1 Intervention
1mg tablets of sirolimus that total the assigned dose
Group II: EverolimusExperimental Treatment1 Intervention
1mg tablets of everolimus that total the assigned dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
2013
Completed Phase 4
~2750
Everolimus
2010
Completed Phase 4
~1510
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,459 Total Patients Enrolled
10 Trials studying Aging
2,589 Patients Enrolled for Aging
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,778 Total Patients Enrolled
17 Trials studying Aging
3,811 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,813 Total Patients Enrolled
160 Trials studying Aging
75,935 Patients Enrolled for Aging
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use birth control to prevent pregnancy during and for 4 weeks after the study.I have chronic kidney disease or my blood tests show poor kidney function.I have diabetes or my blood sugar levels are high.I have bleeding issues or take medication that affects my bleeding time.I am a middle-aged adult with no chronic diseases.I am willing and able to follow the study rules and attend all appointments.I can take pills by mouth.I have had sores or ulcers in my mouth before.I have a long-term lung problem with specific breathing test results.I am taking medication to lower my blood sugar.I have a history of heart disease or an abnormal ECG.My cancer is active or I've been in remission for less than 5 years.I have a history of Alzheimer's disease.I am taking medications that may weaken my immune system or affect certain enzymes.My blood tests for organ function are within normal ranges.I plan to have surgery within 12 weeks before or during the study period.I have a history of stroke or cerebrovascular disease.I can use a phone and be reached by one.I have a history of liver disease or my liver tests are high.
Research Study Groups:
This trial has the following groups:- Group 1: Sirolimus
- Group 2: Everolimus
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities to get involved in this clinical research endeavor currently?
"As per the data found on clinicaltrials.gov, this medical trial is not recruiting patients at present; the listing was created on January 1st 2024 and last amended on July 17th 2023. Nonetheless, there are currently 247 other trials searching for volunteers."
Answered by AI
Has Sirolimus been cleared for use by the Food and Drug Administration?
"The safety of Sirolimus is rated as a 1 on the scale due to its Phase 1 status, indicating that there are only preliminary data attesting its efficacy and limited evidence backing up its security."
Answered by AI
Would I be a suitable participant in this trial?
"This clinical trial seeks individuals aged between 55 and 80, with a target of 72 successful applicants."
Answered by AI
Is the cutoff age for this clinical investigation restricted to those below 60?
"Those hoping to be enrolled in this trial must fall between the ages of 55 and 80. Notably, there are 1 studies for people under 18 years old and 240 studies for senior citizens above 65."
Answered by AI
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