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New treatment option for Repetitive Head Impacts
Official title Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation
ClinicalTrials.gov ID: NCT07050173
What this study is testing
What is Gamma-glutamylcysteine (GGC)?
Gamma-glutamylcysteine (GGC) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for repetitive head impacts.
Also referred to as GGC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 70
You may be able to join if
- 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.
You likely can't join if
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body.
- people 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...
- people with a history of cancer;
- people with active psychosis or delirium;
- people with chronic kidney (creatinine \> 1.5mg/dL) or liver disease (AST ≥ 1.5 ULN; ALT ≥1.5 ULN) within 30 days prior to enrollment;
See the full eligibility 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.
- Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body.
- people 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...
- people with a history of cancer;
- people with active psychosis or delirium;
- people with chronic kidney (creatinine \> 1.5mg/dL) or liver disease (AST ≥ 1.5 ULN; ALT ≥1.5 ULN) within 30 days prior to enrollment;
- people 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;
- people with repeated head injury within the last 90 days.
The study team makes the final eligibility decision.
Where it's taking place
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.