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

Must not have

Postmenopausal women on HRT

Premenopausal women

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a personalized mix of medicines to help regenerate the thymus, an important part of the immune system that weakens with age. The treatment includes a growth hormone, a diabetes drug (metformin), and a hormone supplement (DHEA). It aims to strengthen the immune system and possibly slow down aging in elderly people.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a postmenopausal woman currently on hormone replacement therapy.

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I am a woman who has not gone through menopause.

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I have a slow heart rate, high blood pressure, severe chest pain, or other serious heart conditions.

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I have severe joint pain or swelling.

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I have or might have growth hormone resistance.

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I am currently taking medication for carbonic anhydrase inhibitors.

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I have carpal tunnel syndrome.

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I am on long-term steroid medication.

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I am a smoker or not willing to quit smoking.

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My thyroid is underactive and not treated.

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I am HIV positive.

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I do not have any unstable health conditions.

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I am not willing to stop taking testosterone supplements even if my levels are high.

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My PSA levels are high, not due to prostatitis.

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I have been diagnosed with Type 1 or Type 2 diabetes.

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I have a high risk of cancer due to my family history or past health issues.

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I have skin growths that can't be treated with freezing.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Epigenetic Age

Safety and Tolerability

Thymus Regeneration

Secondary study objectives

Immunosenescence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TRIIM TreatmentExperimental Treatment1 Intervention

Group II: Active ControlActive Control1 Intervention

0 / 18Eligibility 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.