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

Phase 1RecruitingNCT07583251

Pravat Mandal9 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Mild Cognitive Impairment (MCI)

Interventions

Gamma- GlutamylcysteineDRUG

400mg capsules once a day

Gamma- GlutamylcysteineDRUG

400mg capsules orally (two times) per day

Gamma- GlutamylcusteineDRUG

400mg capsules orally (three times) per day

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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;

Locations (1)

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

No. of participants with abnormal kidney and liver function tests after 30 days of supplementation.

Safety: Creatinine not more than 1.5mg/dL, AST and ALT levels not more than 1.5 X ULN.

Time frame: 1 month

Number of participants with treatment-related adverse events with one dose of GGC as assessed by CTCAE.

Safety and Tolerability

Time frame: 3 months

Number of participants with treatment-related adverse events with two doses of GGC as assessed by CTCAE.

Safety and tolerability

Time frame: 3 months

Number of participants with treatment-related adverse events with three doses of GGC as assessed by CTCAE.

Safety and tolerabitily

Time frame: 3 months

Number of participants with abnormal laboratory test results after 3 months of GGC supplementation.

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.

Time frame: 3 months

Secondary Outcomes

Changes in baseline blood glutathione levels (µmol/l) in people with MCI due to GGC supplementation.

Time frame: 3.5 months

Changes in blood iron levels(ng/μl) in people with MCI due to GGC supplementation.

Time frame: 3.5 months

Central Contacts

Pravat Pravat K MANDAL

CONTACT

4126999561 mandalpk@pitt.edu

Nazia Pillar

CONTACT

878-670-3123 clinic55@pitt.edu

Data from ClinicalTrials.gov

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