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

NCT07583251 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: STUDY260200480021
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment (MCI)

Keywords

GSH; GGC; MCI; cognitive

Outcome Measures

Primary Outcomes (5)

• No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.

  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.

  Safety and Tolerability

  3 months

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

  Safety and tolerability

  3 months

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

  Safety and tolerabitily

  3 months

• Number of participants with abnormal laboratory test results after 3 months of GGC supplementation.

  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 Outcomes (2)

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

  3.5 months

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

  3.5 months

Study Arms (3)

Gamma - Glutamylcystiene 400

EXPERIMENTAL

Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months.

Drug: Gamma- Glutamylcysteine

Gamma - Glutamylcystiene 800

EXPERIMENTAL

Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months

Drug: Gamma- Glutamylcysteine

Gamma - Glutamylcystiene 1200

EXPERIMENTAL

Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months

Drug: Gamma- Glutamylcusteine

Interventions

Gamma- Glutamylcysteine DRUG

400mg capsules once a day

Gamma - Glutamylcystiene 400

Gamma- Glutamylcusteine DRUG

400mg capsules orally (three times) per day

Gamma - Glutamylcystiene 1200

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Pravat Mandal: lead
• Robert J. Coury Family - Mylan Foundation: collaborator
• Inid Research Lab: collaborator

Study Sites (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• 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.

  PMID: 26003861 BACKGROUND

• 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.

  PMID: 37257017 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

gamma-glutamylcysteine

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Pravat Mandal, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pravat Pravat K MANDAL

CONTACT

4126999561; mandalpk@pitt.edu

Nazia Pillar

CONTACT

878-670-3123; clinic55@pitt.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Professor

Model Details: 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. The participants will be given the GGC supplement: Group A: 400mg once a day/ Group B: 400 mg two times per day/ Group C: 400mg three times a day for three months. Group B starts after Group A's 30-day safety review. Group C starts after Group B's 30-day safety review is cleared. If 1 participant within the cohort(n=3) experiences dose-limiting toxicity (DLT) or clinically significant intolerance, the event will be reviewed by the clinician for severity, relatedness, and significance. Dose escalation may proceed if the event is not indicative of an overall safety concern (Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN).If 2 or all of the participants experience DLTs or clinically significant adverse events related to the study supplement, dose escalation will be halted.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

US (1)