Mild Cognitive Impairment (MCI)
Conditions
Keywords
GSH, GGC, MCI, cognitive
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.
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.
Interventions
400mg capsules once a day
DRUGGamma- Glutamylcusteine
400mg capsules orally (three times) per day
Sponsors
Pravat Mandal
Robert J. Coury Family - Mylan Foundation
Inid Research Lab
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| No. of participants with abnormal kidney and liver function tests after 30 days of supplementation. | 1 month | Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN. |
| Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE. | 3 months | Safety and Tolerability |
| Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE. | 3 months | Safety and tolerability |
| Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE. | 3 months | Safety and tolerabitily |
| Number of participants with abnormal laboratory test results after 3 months of GGC supplementation. | 3 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTPravat Pravat K MANDAL
CONTACTNazia Pillar
PRINCIPAL_INVESTIGATORPravat Mandal, PhD
University of Pittsburgh
Outcome results
None listed