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mTOR Inhibitor

Rapamycin for Aging (mTOR Trial)

Phase 2
Recruiting
Led By Dean L Kellogg, Jr., MD PhD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects will be in good general health with all chronic diseases (hypertension, coronary artery disease, etc.) clinically stable
70-95 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 8 weeks
Awards & highlights

mTOR Trial Summary

This trial will test whether rapamycin can improve the health of elderly humans by looking at various age-related declines. One part of the trial will focus on cardiac function.

Who is the study for?
This trial is for healthy elderly individuals aged 70-95 with stable chronic conditions. They must pass an MRI safety screening and have no history of skin ulcers, liver disease, poorly controlled diabetes, or recent use of certain medications like systemic immunosuppressants or drugs affecting cytochrome P450 3A. Smokers and females are excluded to avoid sex-based response differences.Check my eligibility
What is being tested?
The study tests if rapamycin can improve life functions in the elderly by focusing on cardiac function. Participants will receive rapamycin treatment as part of Substudy E to see if it benefits heart health similar to effects seen in animal studies.See study design
What are the potential side effects?
Rapamycin may cause side effects such as increased risk of infections due to its immune-suppressing properties, potential impact on wound healing, and possible interactions with other medications that affect metabolism.

mTOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My chronic conditions, like high blood pressure or heart disease, are under control.
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I am between 70 and 95 years old.
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My health conditions are stable, with or without medication.

mTOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aortic Cross-Sectional Area
Aortic Distensibility
Diastolic Function
+1 more

Side effects data

From 2022 Phase 2 & 3 trial • 107 Patients • NCT03826628
36%
Skin burning sensation
25%
Pruritus
19%
Erythema
19%
Dry Skin
8%
Pain of skin
6%
Skin tightness
6%
Paraesthesia
6%
Seizure
6%
Acne
6%
Rash
6%
Skin haemorrhage
6%
Urinary tract infection
6%
Haemorrhage
3%
Pyrexia
3%
Chest pain
3%
Folliculitis
3%
Rhinitis
3%
Nausea
3%
Tumour haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
0.5% Rapamycin Cream, Topical
1.0% Rapamycin Cream, Topical
Placebo

mTOR Trial Design

1Treatment groups
Experimental Treatment
Group I: RapamycinExperimental Treatment1 Intervention
Rapamycin 1mg for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
rapamycin
2001
Completed Phase 3
~340

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
450 Previous Clinical Trials
87,250 Total Patients Enrolled
10 Trials studying Aging
1,285 Patients Enrolled for Aging
The Claude D. Pepper Older Americans Independence CentersOTHER
9 Previous Clinical Trials
286 Total Patients Enrolled
1 Trials studying Aging
21 Patients Enrolled for Aging
National Institute on Aging (NIA)NIH
1,658 Previous Clinical Trials
28,004,487 Total Patients Enrolled
160 Trials studying Aging
75,995 Patients Enrolled for Aging

Media Library

Rapamycin (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04742777 — Phase 2
Aging Research Study Groups: Rapamycin
Aging Clinical Trial 2023: Rapamycin Highlights & Side Effects. Trial Name: NCT04742777 — Phase 2
Rapamycin (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04742777 — Phase 2

Frequently Asked Questions

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

How is rapamycin most commonly used?

"Rapamycin can be used to treat patients that have been rejected from a liver or kidney transplant as well as those suffering from certain diseases."

Answered by AI

Are there any positions available in this clinical trial for new patients?

"This study, which was originally posted on February 1st, 2022, is currently looking for participants. The most recent update to the listing was on May 17th, 2022."

Answered by AI

What other drugs has rapamycin been tested against in previous clinical trials?

"There are presently 130 trials ongoing that rapamycin is being studied in. Of these, 13 are large-scale Phase 3 studies. Most of the research for rapamycin is centred in Cincinnati, Ohio; though, there are 1084 locations running clinical trials involving rapamycin."

Answered by AI

Has the FDA accepted rapamycin for therapeutic use?

"While there is some evidence that rapamycin is safe, it has not yet been proven effective in clinical trials. Therefore, it receives a score of 2."

Answered by AI

How many people are enrolled in this experiment?

"Per the information provided on clinicaltrials.gov, this study is still recruiting patients. The trial was originally posted on February 1st, 2022 and was most recently edited on May 17th, 2022. The trial is looking for 12 participants that will be seen at 2 locations."

Answered by AI

Who would this clinical trial be appropriate for?

"The study is currently seeking 12 individuals aged 70-95 that meet the following health requirements: good general health, clinically stable chronic diseases, and complete physical, mental, and social well-being."

Answered by AI

Could older patients benefit from this treatment option?

"The oldest patients that can be recruited for this study are 95 years old, and the youngest patients must be at least 70."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Audie L. Murphy Memorial Veterans Hospital
What portion of applicants met pre-screening criteria?
Met criteria
~5 spots leftby Dec 2025