What side effects are associated with this type of intervention?

The most common treatments for age-related immune decline, such as somatropin, metformin, and DHEA, have several known side effects. Somatropin can cause joint and muscle pain, fluid retention, and an increased risk of diabetes. Metformin may lead to gastrointestinal issues like nausea and diarrhea, and in rare cases, lactic acidosis. DHEA can result in oily skin, hair loss, stomach upset, and changes in menstrual cycle or mood. These side effects should be weighed against the potential benefits when considering these treatments.

What prior FDA approvals exist?

The FDA has approved somatropin (recombinant human growth hormone) for adult growth hormone deficiency, which can help stimulate growth and cell regeneration. Metformin, primarily approved for type 2 diabetes, is also recognized for its potential anti-aging effects and improvement of insulin sensitivity. DHEA (dehydroepiandrosterone) is available as a dietary supplement and serves as a precursor to sex hormones, with potential anti-aging properties. While these drugs are approved for specific conditions, their combined use for treating age-related immune decline is still under investigation and not yet FDA-approved for this specific purpose.

What other types of research exist?

Promising novel alternatives for treating age-related immune decline in 2024 include: <ol> <li>Thymus Regeneration Therapies: These aim to rejuvenate the thymus gland, which is crucial for T-cell production.</li> <li></li> </ol> Senolytics: Drugs that selectively clear senescent cells, potentially reducing chronic inflammation and improving immune function. 3. NAD+ Boosters: Compounds like nicotinamide riboside or nicotinamide mononucleotide that enhance cellular repair and mitochondrial function. 4. mTOR Inhibitors: Drugs like rapamycin that modulate the mTOR pathway, which is involved in aging and immune function. 5. Advanced Immunomodulators: New biologics or small molecules that specifically enhance the function of immune cells, such as T-cells and natural killer cells.

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Thymus Regeneration Therapy for Age-Related Immune Decline (TRIIM-X Trial)

Phase 2

Recruiting

Research Sponsored by Intervene Immune, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 40 to 80 years, inclusive

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

TRIIM-X Trial Summary

This trial is a study to see if a combination of 3 drugs can help regenerate the thymus, which is part of the immune system that declines as we age. The study will also evaluate if this combination can help prevent or reverse aspects of aging and potentially help prevent or reduce the risk of developing age-related diseases.

Who is the study for?

The TRIIM-X trial is for men and women aged 40 to 80, from any ethnicity, who can commit to a year-long study. It's not suitable for smokers, those with growth hormone deficiencies or high cancer risks, people on certain medications like steroids or HRT, anyone with serious heart conditions or uncontrolled diabetes, and premenopausal women.Check my eligibility

What is being tested?

This trial tests a personalized treatment aiming to regenerate the thymus and improve immune function in older adults. It involves recombinant human growth hormone (somatropin), metformin, DHEA doses based on prior trials' safety data. The goal is to refine this regimen for broader use and validate biomarkers related to aging prevention.See study design

What are the potential side effects?

Potential side effects may include reactions typical of growth hormones such as joint pain, swelling due to fluid retention (edema), muscle pain; metformin might cause digestive issues; DHEA could affect mood and energy levels. Individual responses can vary.

TRIIM-X Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 40 and 80 years old.

TRIIM-X Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Epigenetic Age

Safety and Tolerability

Thymus Regeneration

Secondary outcome measures

Immunosenescence

TRIIM-X Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TRIIM TreatmentExperimental Treatment1 Intervention

Group II: Active ControlActive Control1 Intervention

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Age-Related Immune Decline, such as somatropin, metformin, and DHEA, work through different mechanisms to improve immune function. Somatropin stimulates growth and cell regeneration, aiding in thymic regeneration and enhancing immune responses. Metformin improves insulin sensitivity and has anti-aging effects, which can reduce inflammation and support immune health. DHEA, a precursor to sex hormones, has potential anti-aging properties that may bolster immune function. These treatments are significant for patients as they address the root causes of immune aging, potentially reversing immune decline and enhancing resistance to infections and age-related diseases.

The effect of hypophysectomy on thymic aging in mice.An aged immune system drives senescence and ageing of solid organs.Androgen supplementation improves some but not all aspects of immune senescence in aged male macaques.