Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

About this trial

Last updated 2 months ago

Study ID

STUDY24120016

Status

Recruiting

Type

Interventional

Phase

Phase 1

Placebo

Accepting

30 to 70 Years

All Sexes

Trial Timing

Started a month ago

What is this trial 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.

What are the participation requirements?

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.