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

Pravat Mandal

Status and phase: Not yet enrolling; Phase 1

Conditions: Mild Cognitive Impairment (MCI)

Treatments: Drug: Gamma- Glutamylcusteine; Drug: Gamma- Glutamylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT07583251

0021 (Other Grant/Funding Number)

STUDY26020048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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9 participants in 3 patient groups

Gamma - Glutamylcystiene 400

Experimental group

Description:

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

Treatment:

Drug: Gamma- Glutamylcysteine

Drug: Gamma- Glutamylcysteine

Gamma - Glutamylcystiene 800

Experimental group

Description:

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

Treatment:

Drug: Gamma- Glutamylcysteine

Drug: Gamma- Glutamylcysteine

Gamma - Glutamylcystiene 1200

Experimental group

Description:

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

Treatment:

Drug: Gamma- Glutamylcusteine