Gamma-glutamylcysteine for Brain Injury
(RHIGSH Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether an oral supplement called gamma-glutamylcysteine (GGC) can protect the brain by boosting a natural antioxidant, glutathione (GSH). The focus is on individuals who have experienced repetitive head impacts, such as retired NFL players or military personnel with combat experience. Researchers aim to determine if GGC can increase GSH levels in the brain and blood and improve cognitive function, including memory and thinking. Ideal participants have experienced memory or behavior issues and have a history of repetitive head impacts. Those with metal implants or recent head injuries are not eligible. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on antioxidant therapy like gingko biloba or N-acetylcysteine.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research shows that gamma-glutamylcysteine (GGC) is usually safe to use. In animal studies, even in large amounts, GGC did not cause any serious side effects or problems, suggesting safety at high doses. Although these results come from animal studies, they offer some confidence about its safety for humans. However, as this trial remains in the early stages, the researchers are still collecting information from human participants.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for brain injury, which often focus on managing symptoms or reducing inflammation, gamma-glutamylcysteine (GGC) works at a cellular level to boost the body's antioxidant defenses. This is exciting because GGC is a precursor to glutathione, a powerful antioxidant that can protect brain cells from damage. Researchers are hopeful that by enhancing the brain's natural defense system, GGC could potentially offer a more proactive approach to mitigating the effects of brain injury, setting it apart from traditional therapies.
What evidence suggests that gamma-glutamylcysteine might be an effective treatment for brain injury?
Studies have shown that gamma-glutamylcysteine (GGC), which participants in this trial will receive, might help protect the brain after injury. Research indicates that a similar compound, gamma-glutamylcysteine ethyl ester, protects brain cells and reduces damage by lowering oxidative stress, which is harm caused by certain molecules. This compound also maintains the brain's protective barrier during injury, crucial for brain health. Early findings suggest that GGC increases levels of an important antioxidant, glutathione, in the brain, which may help repair and protect brain cells. These promising results have led to testing GGC for its potential to improve brain function after repeated head impacts.14678
Who Is on the Research Team?
Pravat K Mandal, PhD
Principal Investigator
University of Pittsburgh
Are You a Good Fit for This Trial?
This trial is for individuals who have experienced repetitive head impacts, potentially leading to conditions like concussion or brain injury. The study aims to include those who could benefit from an antioxidant supplement that might protect the brain.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive gamma-glutamylcysteine (GGC) supplementation orally, 400mg twice daily for 12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gamma-glutamylcysteine (GGC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pravat Mandal
Lead Sponsor
Chuck Noll Foundation
Collaborator