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Repetitive Head ImpactsPhase 1RHIGSHNCT07050173

Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supplementation

A Phase 1 study testing Gamma-glutamylcysteine (GGC) in people with Repetitive Head Impacts, run by Pravat Mandal at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 30 to 70 years
Conditions the study is for
Repetitive Head Impacts
What is being tested?
Gamma-glutamylcysteine (GGC)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 May 2026to 27 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pravat K MANDAL, PHD contact

4126999561

mandalpk@pitt.edu

United States1 site, 1 recruiting

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

    Pravat K Mandal, PhD, 412-699-9561, mandalpk@pitt.edu

    Nazia Pillar, Ms, 8573702614, naa430@pitt.edu

    Recruiting

Other trials in United States

About this study

Official title: Patients With Repetitive Head Impact Orally Supplemented With Gamma-glutamylcysteine: An Open Label Trial With MR Spectroscopy and Neuropsychological 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. Change in GSH in brain and blood levels through GGC supplementation.
  2. Change in the cognitive function in RHI patients due to GGC supplementation.
Read the detailed description

This study is designed to evaluate the effects of GGC supplementation in patients with a history of repetitive head impacts (RHI) who are at risk for developing Traumatic Encephalopathy Syndrome (TES). The trial will include specific individuals who satisfy the eligibility criteria.

Being tested
Gamma-glutamylcysteine (GGC)
Keywords
Brain injury, Glutathione, MR spectroscopy, Non- invasive, GGC, RHI, TES, Brain, Blood
Medical subject headings
Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gamma-glutamylcysteine (GGC)Drug

    Also called GGC

    400mg tablet orally (two times) per day.

Study groups in NCT07050173
Study groupRoleWhat they receive
Gamma - GlutamylcystieneExperimentalEach participant will receive gamma-glutamyl cysteine (GGC) tablet orally 400mg (two times) per day once in the morning and once in the evening for 12 months.
Receives: Drug: Gamma-glutamylcysteine (GGC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation.

    (MRS) is a non-invasive imaging technique, to detect various neurochemical (e.g. glutathione) using MEGA-PRESS sequence from 1H MR spectroscopy.

    Measured: 12 months

  2. Changes in baseline blood glutathione levels (µmol/l) in people with RHI due to GGC supplementation.

    Measured: 12 months

  3. Changes in blood iron levels(ng/μl) in people with RHI due to GGC supplementation.

    Measured: 12 months

Secondary outcomes (8)

  1. Correlation between glutathione and iron levels in the brain and blood with dysbiotic features of the gut microbiome in people with RHI.

    Brain imaging, blood and stool samples will be collected to determine the correlation between glutathione and iron levels in the brain and blood with dysbiotic features of the gut microbiome in people with RHI.

    Measured: 12 months

  2. Changes from baseline in the cognitive functions (immediate memory, visuospatial memory, language etc) using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) in people with RHI .

    Interpretation: Higher scores > 70 indicate greater cognitive function (PMID =36648917)

    Measured: 12 months

  3. Changes in brain iron levels (ppb) in people with RHI using susceptibility mapping between pre and post supplementation.

    Measured: 12 months

  4. Changes from baseline in the cognitive functions ( executive functions like attention, speed, and mental flexibility ) using Trail Making Test (TMT) A&B in people with RHI.

    Scoring Method: The average scores are as follows:

    • Trail A - 29 seconds
    • Trail B - 75 seconds Interpretation: Higher scores indicate greater impairment

    Measured: 12 months

  5. Changes from baseline in the cognitive functions and emotional well-being using Delis-Kaplan Executive Functioning System (D-KEFS) Color Word Interference test in people with a RHI

    Interpretation: Higher score (> 7) (PMID=21122190) indicates greater executive functions which includes cognitive abilities essential for tasks such as planning, problem-solving, and decision-making.

    Measured: 12 months

  6. Changes from baseline in the cognitive functions and emotional well-being using Test of Premorbid Functioning (TOPF ) in people with RHI (PMID=36648917)

    Interpretation of the results: Higher scores (>45 above 315191110 indicate better cognitive and memory function.

    Measured: 12 months

  7. Changes from baseline in the cognitive functions and emotional wellbeing using Brief Symptom Inventory (BSI-18) (self-report) in people RHI .

    Scoring Method: Each item is scored on a 0-4 scale, with the total score indicating the severity of distress.

    Interpretation: Higher total scores indicate greater severity of psychological distress.

    Measured: 12 months

  8. Changes from baseline in the cognitive functions and emotional well-being using PROMIS Cognitive Function -Short Form 8a (self-report) tool in people RHI.

    Scoring Method:

    Raw Score: 8-40 Interpretation: Lower scores on this measure indicate greater subjective cognitive difficulty.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2025
  2. Study start1 May 2026
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion27 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07050173
Sponsor's protocol ID
STUDY24120016
Other IDs
0025
Acronym
RHIGSH
Status last verified
Jun 2026
First submitted
20 Jun 2025
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Clinical study report data will be provided after the study data is analyzed and published. A comprehensive report will be sent to the IRB. The respective agency will be reported accordingly. Requests for the release of data must be submitted in writing to the PI, clearly stating the purpose of the request, the specific data needed, and the intended use. The PI, in collaboration with the research team, will review each request to ensure compliance with institutional policies, ethical standards, and any relevant data use agreements.

Publications

  • Mandal PK, Dwivedi D, Joon S, Goel A, Ahasan Z, Maroon JC, Singh P, Saxena R, Roy RG. Quantitation of Brain and Blood Glutathione and Iron in Healthy Age Groups Using Biophysical and In Vivo MR Spectroscopy: Potential Clinical Application. ACS Chem Neurosci. 2023 Jun 21;14(12):2375-2384. doi: 10.1021/acschemneuro.3c00168. Epub 2023 May 31.

    PubMed 37257017

  • Mandal PK, Saharan S, Tripathi M, Murari G. Brain glutathione levels--a novel biomarker for mild cognitive impairment and Alzheimer's disease. Biol Psychiatry. 2015 Nov 15;78(10):702-10. doi: 10.1016/j.biopsych.2015.04.005. Epub 2015 Apr 14.

    PubMed 26003861

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gamma-glutamylcysteine (GGC) in people with Repetitive Head Impacts, run by Pravat Mandal at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pravat K MANDAL, PHD (4126999561, mandalpk@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in brain glutathione levels (mM) in people with Repetitive Head Injury (RHI) using Magnetic Resonance Spectroscopy in pre and post supplementation. (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07050173, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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