Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-12-27

Brief Summary

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The goal of this clinical trial is to test whether the gamma - glutamylcystiene (GGC) oral supplement can reach the brain and subsequently increase antioxidant glutathione (GSH) level in people with repetitive head impact (RHI). This will reduce the oxidative stress related injury in people with RHI.This unique study's main objective is to test the:

1. Change in GSH in brain and blood levels through GGC supplementation.
2. Change in the cognitive function in RHI patients due to GGC supplementation.

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Detailed Description

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This study is designed to evaluate the effects of GGC supplementation in patients with a history of repetitive head impacts (RHI) who are at risk for developing Traumatic Encephalopathy Syndrome (TES). The trial will include specific individuals who satisfy the eligibility criteria.

Conditions

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Repetitive Head Impacts

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Gamma - Glutamylcystiene

Each participant will receive gamma-glutamyl cysteine (GGC) tablet orally 400mg (two times) per day once in the morning and once in the evening for 12 months.

Group Type EXPERIMENTAL

Gamma-glutamylcysteine (GGC)

Intervention Type DRUG

400mg tablet orally (two times) per day.

Interventions

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Gamma-glutamylcysteine (GGC)

400mg tablet orally (two times) per day.

Intervention Type DRUG

Other Intervention Names

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GGC

Eligibility Criteria

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Inclusion Criteria

* Retired NFL player, retired Navy SEAL/army personnel with combat experience exposed to repetitive head impact;
* Memory and behavioral complaint per self- or informant-report;
* Age (30 to 70 years of age) years;
* Able to read and write in English and to give consent to participate in the study.

Exclusion Criteria

* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body.
* Subjects with claustrophobia.
* Subject with mild cognitive impairment \[TICS score of 29 or lower OR \>=1.0 standard deviations below age-expectation on at least two cognitive members within the same cognitive domain (e.g. memory, attention, etc.) on the baseline neuropsychological testing;
* Subjects with a history of cancer;
* Subjects with active psychosis or delirium;
* Subjects with chronic kidney (creatinine \> 1.5mg/dL) or liver disease (AST ≥ 1.5 ULN; ALT ≥1.5 ULN) within 30 days prior to enrollment;
* Subjects on antioxidant therapy (gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl;
* Repeated head injury patients with neurosurgical intervention and;
* Subjects with repeated head injury within the last 90 days.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No