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

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

Recruiting
55-80 years
All
Phase 1

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Overview

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.

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.

Eligibility

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 details
    Mild Cognitive Impairment (MCI)

NCT07583251

Pravat Mandal

27 June 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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