Safety And Tolerability Of Gamma Glutamylcysteine (GGC) Oral Supplementation In MCI Patients
Purpose
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.
Condition
- Mild Cognitive Impairment (MCI)
Eligibility
- Eligible Ages
- Between 55 Years and 80 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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;
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Prevention
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Gamma - Glutamylcystiene 400 |
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg once a day for 3 months. |
|
|
Experimental Gamma - Glutamylcystiene 800 |
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg two times(morning-evening) a day for 3 months |
|
|
Experimental Gamma - Glutamylcystiene 1200 |
Each participant will receive gamma-glutamyl cysteine (GGC) capsules orally 400mg three times (morning-afternoon - evening) a day for 3 months |
|
Recruiting Locations
Pittsburgh, Pennsylvania 15213
More Details
- Status
- Recruiting
- Sponsor
- Pravat Mandal
Detailed 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.