RecruitingPhase 1NCT07050173

Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

Patients With Repetitive Head Impact Orally Supplemented With Gamma-glutamylcysteine: An Open Label Trial With MR Spectroscopy and Neuropsychological Testing


Sponsor

Pravat Mandal

Enrollment

30 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 30 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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.

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Interventions

DRUGGamma-glutamylcysteine (GGC)

400mg tablet orally (two times) per day.


Locations(1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

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NCT07050173


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