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

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.

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.

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