Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients (MCI-GSH)

May 29, 2026 updated by: Pravat Mandal

Study For Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients

The goal of this study is to evaluate the safety and tolerability of Gamma Glutamylcysteine (GGC) supplement at different doses (400mg/day or 800mg/day or 1200mg/day) when administered orally to patients with MCI over 3 months. This study is designed to generate preliminary clinical safety data to inform the feasibility and design of larger controlled trials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Oxidative Stress (OS) plays a key role in aging and neurodegenerative diseases, including Alzheimer's Disease. The brain's primary antioxidant, GSH, is essential for combating Reactive Oxygen Species (ROS).This study is designed as an open-label, single-center, dose escalation clinical trial to evaluate the safety and tolerability of GGC supplementation in patients with MCI. This will enable the investigators to identify maximum tolerated or recommended dose for further clinical evaluation.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • UPMC Presbyterian Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Riddhi Patira, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Memory complaints;
  2. MCI diagnosis
  3. MoCA score between 18-25
  4. Age 55 - 80 years old.
  5. Ability to read and write in English

Exclusion Criteria:

  1. Subjects with acute head trauma or head injury involving loss of consciousness;
  2. Subjects with a history of cancer;
  3. Subjects with a history of schizophrenia, manic-depressive disorder
  4. Subjects on antioxidant therapy (ashwagandha, gingko biloba, N-acetylcysteine or glutathione)
  5. Subjects on illicit drug (cocaine, heroin, marijuana, or fentanyl) abuse/dependence;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gamma - Glutamylcystiene 400
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months.
Drug: Gamma- Glutamylcysteine
400mg capsules once a day
Drug: Gamma- Glutamylcysteine
400mg capsules orally (two times) per day
Experimental: Gamma - Glutamylcystiene 800
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months
Drug: Gamma- Glutamylcysteine
400mg capsules once a day
Drug: Gamma- Glutamylcysteine
400mg capsules orally (two times) per day
Experimental: Gamma - Glutamylcystiene 1200
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months
Drug: Gamma- Glutamylcusteine
400mg capsules orally (three times) per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.
Time Frame: 1 month
Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.
1 month
Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.
Time Frame: 3 months
Safety and Tolerability
3 months
Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.
Time Frame: 3 months
Safety and tolerability
3 months
Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.
Time Frame: 3 months
Safety and tolerabitily
3 months
Number of participants with abnormal laboratory test results after 3 months of GGC supplementation.
Time Frame: 3 months
Safety and tolerability: The number of participants experiencing clinically significant abnormal laboratory test results (hematology, kidney, and liver function tests) during 3 months of GGC supplementation, compared with baseline.
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in baseline blood glutathione levels (µmol/l) in people with MCI due to GGC supplementation.
Time Frame: 3.5 months
3.5 months
Changes in blood iron levels(ng/μl) in people with MCI due to GGC supplementation.
Time Frame: 3.5 months
3.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pravat Mandal

Collaborators

Robert J. Coury Family - Mylan Foundation
Inid Research Lab

Investigators

  • Principal Investigator: Pravat Mandal, PhD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

April 29, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 13, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY26020048
  • 0021 (Other Grant/Funding Number: Robert J. Coury Family - Mylan Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data underlying the primary and secondary outcome analyses 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.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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