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New treatment option for Epigenetic Aging
Official title Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
ClinicalTrials.gov ID: NCT04375657
What this study is testing
What is TRIIM Treatment?
TRIIM Treatment is an investigational medicine, being studied as a potential treatment for epigenetic aging.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The TRIIM-X trial is an expanded pilot clinical study that will evaluate a personalized combination treatment regimen for thymus regeneration. The thymus is a part of the immune system that declines markedly with age, and regenerating it may prevent or reverse key aspects of immunosenescence (immune system aging) and potentially prevent or reverse key parts of the aging process more generally.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Male or female volunteers
- Aged 40 to 80 years, inclusive
- All ethnicities
- Able to participate in 12-month study
- Able to provide informed consent
You likely can't join if
- Malignancies or high risk of malignancy, as suggested by familial risk or personal medical history
- Premenopausal women
- Postmenopausal women on HRT
- IGF-1 levels \ 300 ng/ml
- Diagnosed or suspected growth hormone resistance
- Known growth hormone deficiency based on stimulation testing
See the full eligibility criteria
- Male or female volunteers
- Aged 40 to 80 years, inclusive
- All ethnicities
- Able to participate in 12-month study
- Able to provide informed consent
- Malignancies or high risk of malignancy, as suggested by familial risk or personal medical history
- Premenopausal women
- Postmenopausal women on HRT
- IGF-1 levels \ 300 ng/ml
- Diagnosed or suspected growth hormone resistance
- Known growth hormone deficiency based on stimulation testing
- Pre-existing carpal tunnel syndrome
- Significant arthritis/arthralgia/joint swelling
- Bradycardia (\ 160 mmHg, or diastolic \>90 mmHg) despite treatment, serious angina, or other serious cardiovascular disease or cardiovascular disease risk factors
- Excessive skin growths (e.g., flat warts) without cryosurgical options
- BMI of 35 or greater
- PSA level above the age-adjusted normal range for reasons other than confirmed prostatitis
- Testosterone levels above the upper limit of normal
- Levels of C-reactive protein (CRP) above the upper limit of normal
- Type 1 or pre-existing Type 2 diabetes
- Uncorrected hypothyroidism
- HIV infection
- Allergy or other sensitivity to study medications
- Other unstable medical conditions
- Use of GH within the last 5 years
- Participation in a clinical research trial within 30 days prior to enrollment
- Use of chronic glucocorticoid therapy
- Unwilling to discontinue androgen supplementation if testosterone levels are above the upper limit of normal
- Ongoing treatment with carbonic anhydrase inhibitors
- Ketogenic diet, calorie-restricted diet, or prolonged fasting, without willingness to discontinue these diets or adhere to an alternative diet during the study
- Alcoholism or drug addiction
- Smoking or unwillingness to quit smoking
- Cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Torrance, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torrance, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.