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Search / Trial NCT07050173

Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

Launched by PRAVAT MANDAL · Jun 25, 2025

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Brain Injury Glutathione Mr Spectroscopy Non Invasive Ggc Rhi Tes Brain Blood

ClinConnect Summary

This clinical trial is studying whether a supplement called gamma-glutamylcysteine (GGC), taken by mouth, can help people who have had repeated hits to the head. The goal is to see if this supplement can reach the brain and increase levels of a natural antioxidant called glutathione, which may protect the brain from damage caused by these head impacts. Researchers will also look at whether taking GGC can improve thinking and memory in these individuals.

The study is looking for adults between 30 and 70 years old who have experienced repeated head impacts, like retired NFL players or military personnel with combat experience. Participants should have concerns about memory or behavior changes and be able to read, write, and give consent in English. People with certain medical conditions, recent head injuries, or who use other antioxidant treatments won’t be eligible. If accepted, participants can expect to have their brain and blood tested to measure glutathione levels and undergo tests to check their thinking skills. This is an early-phase study, meaning it’s one of the first steps to see if this supplement might be helpful and safe for people with repeated head injuries.

Gender

ALL

Eligibility criteria

  • 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.

About Pravat Mandal

Pravat Mandal is a clinical trial sponsor dedicated to advancing medical research through the development and support of innovative clinical studies. With a focus on improving patient outcomes, Pravat Mandal facilitates rigorous trial design and execution across various therapeutic areas, ensuring adherence to regulatory standards and ethical guidelines. Their commitment to scientific excellence and patient safety drives the progression of new treatments from concept to clinical application.

Locations

Pittsburgh, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Pravat K Mandal, PhD

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported