Brain Glutathione (GSH) Enrichment Through Gamma-glutamylcysteine (GGC) Supplementation in Early Parkinson's Disease Patients for Reduction of Extrapyramidal Motor Disturbances and Halting Cognition Decline: A Pilot Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC.
研究概览
简要总结
This study is designed l to evaluate the effects of GGC oral supplementation in early Parkinson's disease (PD) patients. The main objectives of the study are to evaluate:
- To study the enrichment of master antioxidant, glutathione (GSH) levels in brain and blood of these PD patients compared to baseline due to GGC supplementation.
- To study the changes in motor function, cognitive skills in PD patients due to GGC oral supplementation
- To study impact of GGC on gut health on the PD patients.
详细描述
This study will measure brain glutathione using non- invasive, state-of-the-art MEGA-PRESS pulse sequence in pre and post GGC supplementation after 12 months. The GSH level will also be measured in the blood in pre and post GGC supplementation. Brain and blood iron level will be measured in pre and post GGC supplementation.
The neuropsychological examination and motor function will be performed in pre and post GGC supplementation.
This study will provide the relation of brain GSH enrichment with motor performance.
Our study will also provide any possible correlation with reduction of dysbiosis of the gut microbiome with GSH enrichment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Parkinson's Disease diagnosis.
- •Montreal Cognitive Assessment (MoCA) greater than or equal to
- •Age (50 to 80 years of age).
- •Ability to read and write in English.
排除标准
- •Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body.
- •Subjects with claustrophobia.
- •Patients with a clinical diagnosis of Parkinson's disease dementia or dementia with Lewy bodies.
- •Subjects with a history of cancer.
- •Subjects with active psychosis or delirium.
- •Subjects with chronic kidney (creatinine > 1.5mg/dL) or liver disease (AST ≥ 1.5 ULN; ALT ≥ 1.5 ULN) within 30 days prior to enrolment.
- •Subjects on antioxidant therapy (ashwagandha, gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl).
- •Subjects with previous traumatic head injury.
研究组 & 干预措施
Gamma - Glutamylcysteine
Patients will receive GGC tablet 400mg orally twice a day (morning and in the afternoon).
干预措施: Gamma- glutamylcysteine (Drug)
结局指标
主要结局
Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC.
时间窗: 12 months
MEGA-PRESS is a non-invasive imaging technique, to detect various neurochemical (e.g., Glutathione) using 1H MR spectroscopy.
Changes in baseline blood iron levels(ng/μl) in people with Parkinson's Disease
时间窗: 12 months
Changes in baseline blood glutathione levels (µmol/l) in people with Parkinson's Disease compared to post-supplementation with GGC
时间窗: 12 months
Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC.
时间窗: 12 months
MEGA-PRESS is a non-invasive imaging technique, to detect various neurochemical (e.g., Glutathione) using 1H MR spectroscopy.
Changes in brain iron levels (ppb) in people with Parkinson's Disease using Magnetic Resonance Imaging between pre and post GGC supplementation.
时间窗: 12 months
Changes in baseline blood iron levels(ng/μl) in people with Parkinson's Disease
时间窗: 12 months
Changes in baseline blood glutathione levels (µmol/l) in people with Parkinson's Disease compared to post-supplementation with GGC
时间窗: 12 months
次要结局
- Monitor the change in the motor function using Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) pre and post GGC supplementation.(12 months)
- Cognitive functions modulation- pre and post GGC supplementation using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).(12 months)
- Changes from baseline in the psychological distress using Brief Symptom Inventory (BSI-18) (self-report) in people with Parkinson's Disease.(12 months)
- Changes from baseline in the cognitive functions like memory, attention and decision-making using PROMIS Cognitive Function - Abilities-Short Form 8a (self-report) in people with Parkinson's Disease.(12 months)
- Changes from baseline cognitive functions like attention, processing speed, and mental flexibility using Trail Making Test (TMT) A&B in people with Parkinson's Disease.(12 months)
- Monitor the change in the motor function using Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) pre and post GGC supplementation.(12 months)
- Cognitive functions modulation- pre and post GGC supplementation using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).(12 months)
- Changes from baseline in the psychological distress using Brief Symptom Inventory (BSI-18) (self-report) in people with Parkinson's Disease.(12 months)
- Changes from baseline in the cognitive functions like memory, attention and decision-making using PROMIS Cognitive Function - Abilities-Short Form 8a (self-report) in people with Parkinson's Disease.(12 months)
- Changes from baseline cognitive functions like attention, processing speed, and mental flexibility using Trail Making Test (TMT) A&B in people with Parkinson's Disease.(12 months)
研究者
Pravat Mandal
Research Assistant Professor
University of Pittsburgh