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NCT Number: NCT07583251

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.

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Key information

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Nazia Pillar

CONTACT

[email protected]

Pravat Mandal

CONTACT

[email protected]

4126999561

Riddhi Patira, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Gamma- Glutamylcysteine

Drug

400mg capsules once a day

Gamma- Glutamylcusteine

Drug

400mg capsules orally (three times) per day

Primary outcomes

  1. 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.

  2. 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. Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.

    Time frame: 3 months

    Safety and tolerability

  4. Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.

    Time frame: 3 months

    Safety and tolerabitily

  5. 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.

Secondary outcomes

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

    Time frame: 3.5 months

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

    Time frame: 3.5 months

Study contacts

Contact information is provided by the study sponsor or research team.

Nazia Pillar

CONTACT

[email protected]

878-670-3123

Pravat Pravat K MANDAL

CONTACT

[email protected]

4126999561

Sponsors and collaborators

Lead sponsor

Pravat Mandal

Other

Collaborators

  • Inid Research Lab
  • Robert J. Coury Family - Mylan Foundation

Registry information

Official study title

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

Acronym: MCI-GSH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 13, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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