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mTOR inhibitor
Everolimus for Aging (EVERLAST Trial)
Phase 2
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
Adults aged 55-80 years old
Ability to take oral medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (pre-intervention), 4, 8, 12, 16, 20, and 24 weeks (post-intervention)
Awards & highlights
EVERLAST Trial Summary
This trial will test if a drug can safely reverse aging in humans aged 55-80. 18-35 year olds will also be monitored to compare age effects.
Who is the study for?
This trial is for adults aged 55-80 with insulin resistance or prediabetes, who can take oral medication and are willing to use contraception. Excluded are those with chronic diseases like Alzheimer's, heart disease, kidney disease; tobacco users; on certain drugs affecting everolimus; pregnant/breastfeeding women; and those not proficient in English.Check my eligibility
What is being tested?
The study tests if Everolimus (0.5 mg daily or 5 mg weekly) can improve aging signs compared to a placebo over 24 weeks. Participants will be randomly assigned to one of the treatments and monitored up to approximately 38 weeks.See study design
What are the potential side effects?
Everolimus may cause mouth sores or ulcers, increase infection risk due to low white blood cell count, bleeding issues especially when combined with certain medications, and potential allergic reactions.
EVERLAST Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 55 and 80 years old.
Select...
I can take pills by mouth.
EVERLAST Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 (pre-intervention), 4, 8, 12, 16, 20, and 24 weeks (post-intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (pre-intervention), 4, 8, 12, 16, 20, and 24 weeks (post-intervention)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Metabolic Function: Change in peripheral insulin sensitivity
Secondary outcome measures
Cardiac Function: Change in fractional shortening velocity
Cognitive Function: Change in cerebral blood flow
Safety: Change in concentration of blood metabolites/enzymes
+6 moreOther outcome measures
Change in concentration of lipid species
Change in skeletal muscle protein abundance
Change in skeletal muscle transcriptome
+13 moreEVERLAST Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Daily Placebo and Weekly Everolimus (5mg/week)Experimental Treatment2 Interventions
Once daily placebo and once weekly (5 mg) everolimus taken orally for 24 weeks
Group II: Daily Everolimus (0.5 mg/day) and Weekly PlaceboExperimental Treatment2 Interventions
Once daily (0.5 mg) everolimus and once weekly placebo taken orally for 24 weeks
Group III: Young Adult Reference GroupActive Control1 Intervention
Baseline testing only
Group IV: Daily Placebo and Weekly PlaceboPlacebo Group2 Interventions
Once daily placebo and once weekly placebo taken orally for 24 weeks
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,443 Total Patients Enrolled
10 Trials studying Aging
2,573 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,797 Total Patients Enrolled
160 Trials studying Aging
75,919 Patients Enrolled for Aging
Adam Konopka, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
3 Previous Clinical Trials
268 Total Patients Enrolled
3 Trials studying Aging
268 Patients Enrolled for Aging
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can use a phone and be reached by one.You have high insulin resistance or prediabetes based on specific criteria.I am currently taking medication that strongly activates CYP3A4.You don't want to avoid eating grapefruit, grapefruit juice, or other foods that can affect how the study drug works in your body.I have been diagnosed with Alzheimer's disease.I have chronic kidney disease.I am taking medication to lower my blood sugar.I am using effective birth control and have a negative pregnancy test.My organ functions are within normal ranges according to recent tests.I have bleeding issues or take medication that affects my bleeding time.You are doing intense exercise for more than 150 minutes per week or planning to start a new intense exercise program during the study.I have a long-term lung condition.I am currently taking medication that strongly affects my body's drug processing.I have had sores or ulcers in my mouth before.I am willing and able to follow all study rules and attend all appointments.I have a brain blood vessel condition.You have a low number of white blood cells.I agree not to use St. John's Wort during the trial.I have diabetes.I am between 55 and 80 years old.My cancer is active or I've been in remission for less than 5 years.I am allergic to lidocaine or everolimus.I have a long-term liver condition.I do not have any long-term illnesses.I can take pills by mouth.I have heart disease.
Research Study Groups:
This trial has the following groups:- Group 1: Daily Everolimus (0.5 mg/day) and Weekly Placebo
- Group 2: Young Adult Reference Group
- Group 3: Daily Placebo and Weekly Placebo
- Group 4: Daily Placebo and Weekly Everolimus (5mg/week)
Awards:
This trial has 0 awards, including: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.
Am I eligible to participate in this research endeavor?
"Eligibility for the trial requires participants to possess symptoms of insulin resistance and be between 18-80 years old. Currently, 86 individuals have been accepted into this research program."
Answered by AI
Could individuals over 45 years old partake in this medical experiment?
"This clinical trial is open to participants aged 18-80. Separately, there are 24 studies running for those under the age of majority and 323 trials accepting patients 65 years or older."
Answered by AI
Are there current opportunities to join this research project?
"Affirmative, the clinicaltrials.gov records demonstrate that this experiment is actively searching for participants. Initially posted on March 24th 2023 and last updated on April 19th , it seeks to recruit 86 patients from 1 medical centre."
Answered by AI
How many volunteers are participating in this clinical research endeavor?
"Affirmative. Clinicaltrials.gov's records indicate that patient recruitment is underway for this clinical trial, which was initially posted on March 24th 2023 and last amended on April 19th of the same year. The study aims to recruit 86 volunteers from a single site."
Answered by AI
Has this medical intervention earned government sanction?
"The safety of this treatment was evaluated to be a 2 due to the Phase 2 status which confirms some evidence regarding its safety, yet lacks clinical proof for efficacy."
Answered by AI
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