Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation (RHIGSH)

Pravat Mandal

Status and phase: Enrolling; Phase 1

Conditions: Repetitive Head Impacts

Treatments: Drug: Gamma-glutamylcysteine (GGC)

Study type: Interventional

Funder types: Other

Identifiers

NCT07050173

0025

STUDY24120016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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/ALT > 2 upper limit of normal) 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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Gamma - Glutamylcystiene

Experimental group

Description:

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.

Treatment:

Drug: Gamma-glutamylcysteine (GGC)