NCT07050173 Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation
| NCT ID | NCT07050173 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Pravat Mandal |
| Condition | Repetitive Head Impacts |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-05-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 ≥ 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.
Contact & Investigator
Pravat K Mandal, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT07050173 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 70 Years, studying Repetitive Head Impacts. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07050173 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07050173 currently recruiting?
Yes, NCT07050173 is actively recruiting participants. Contact the research team at mandalpk@pitt.edu for enrollment information.
Where is the NCT07050173 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT07050173 clinical trial?
NCT07050173 is sponsored by Pravat Mandal. The principal investigator is Pravat K Mandal, PhD at University of Pittsburgh. The trial plans to enroll 30 participants.