Parkinsons Disease (PD)
Conditions
Keywords
Blood, Brain, MR Spectroscopy, GGC, Glutathione, Parkinsons disease, Oxidative stress, Brain Iron
Brief summary
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: 1. 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. 2. To study the changes in motor function, cognitive skills in PD patients due to GGC oral supplementation 3. To study impact of GGC on gut health on the PD patients.
Detailed description
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.
Interventions
400 mg (two times) per day
Sponsors
Pravat Mandal
Waste Connections Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed Parkinson's Disease diagnosis. * Montreal Cognitive Assessment (MoCA) greater than or equal to 26. * Age (50 to 80 years of age). * Ability to read and write in English.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC. | 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. | 12 months | — |
| Changes in baseline blood iron levels(ng/μl) in people with Parkinson's Disease | 12 months | — |
| Changes in baseline blood glutathione levels (µmol/l) in people with Parkinson's Disease compared to post-supplementation with GGC | 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Scoring Method: Each section of the UPDRS is scored on a scale from 0 to 4.The total UPDRS score is calculated by summing the scores from each section, ranging from 0 (no disability) to 176 (severe disability). Interpretation: Higher scores indicates greater severity of symptoms. |
| Cognitive functions modulation- pre and post GGC supplementation using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). | 12 months | Interpretation: Higher scores indicate greater cognitive function. |
| Changes from baseline in the psychological distress using Brief Symptom Inventory (BSI-18) (self-report) in people with Parkinson's Disease. | 12 months | Scoring Method: Each item is scored on a 0-4 scale, with the total score indicating the severity of distress. Interpretation: Higher total scores indicate greater severity of psychological distress. |
| 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 | Scoring Method: Raw Score: 8-40 Interpretation: Lower scores on this measure indicate greater subjective cognitive difficulty. |
| 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 | Scoring Method: The average scores are as follows: • Trail A - 29 seconds • Trail B - 75 seconds Interpretation: Higher scores indicate greater impairment |
Countries
United States
Contacts
CONTACTPravat K MANDAL, PHD
CONTACTNazia Pillar, M.S
PRINCIPAL_INVESTIGATORPravat K Mandal, PHD
University of Pittsburgh
Outcome results
None listed