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| ID | Type | Description | Link |
|---|---|---|---|
| 2001 | Other Grant/Funding Number | Waste Connections INC |
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| Name | Class |
|---|---|
| Waste Connections Inc | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamma - Glutamylcysteine | Experimental | Patients will receive GGC tablet 400mg orally twice a day (morning and in the afternoon). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma- glutamylcysteine | Drug | 400 mg (two times) per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC. | MEGA-PRESS is a non-invasive imaging technique, to detect various neurochemical (e.g., Glutathione) using 1H MR spectroscopy. | 12 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Monitor the change in the motor function using Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) pre and post GGC supplementation. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pravat K MANDAL, PHD | Contact | 4126999561 | mandalpk@pitt.edu | |
| Nazia Pillar, M.S | Contact | 878-670-3123 | naa430@pitt.edu |
| Name | Affiliation | Role |
|---|---|---|
| Pravat K Mandal, PHD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Presbyterian Hospital | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24252804 | Background | Dias V, Junn E, Mouradian MM. The role of oxidative stress in Parkinson's disease. J Parkinsons Dis. 2013;3(4):461-91. doi: 10.3233/JPD-130230. | |
| 38050970 | Background | Shukla D, Goel A, Mandal PK, Joon S, Punjabi K, Arora Y, Kumar R, Mehta VS, Singh P, Maroon JC, Bansal R, Sandal K, Roy RG, Samkaria A, Sharma S, Sandhilya S, Gaur S, Parvathi S, Joshi M. Glutathione Depletion and Concomitant Elevation of Susceptibility in Patients with Parkinson's Disease: State-of-the-Art MR Spectroscopy and Neuropsychological Study. ACS Chem Neurosci. 2023 Dec 20;14(24):4383-4394. doi: 10.1021/acschemneuro.3c00717. Epub 2023 Dec 5. |
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De-identified individual participant data (IPD) collected during the trial, specifically data such as specimen type, relevant clinical characteristics based on primary and secondary outcome measures as reported in the summary results.
The IPD report will be accessible starting 6 months after publication of the main results.
Collaborating researchers with IRB approval or individuals listed on data use agreements may obtain data or specimens. The PI, Dr. Pravat K Mandal, University of Pittsburgh, mandalpk@pitt.edu, in collaboration with the research team, will review each request through email to ensure compliance with institutional policies, ethical standards, and any relevant data use agreements. All requests will be reviewed and responded to within 30 days.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C017341 | gamma-glutamylcysteine |
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| 12 months |
| Cognitive functions modulation- pre and post GGC supplementation using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). | Interpretation: Higher scores indicate greater cognitive function. | 12 months |
| Changes from baseline in the psychological distress using Brief Symptom Inventory (BSI-18) (self-report) in people with Parkinson's Disease. | 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. | 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. | Scoring Method: Raw Score: 8-40 Interpretation: Lower scores on this measure indicate greater subjective cognitive difficulty. | 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. | Scoring Method: The average scores are as follows: • Trail A - 29 seconds • Trail B - 75 seconds Interpretation: Higher scores indicate greater impairment | 12 months |
| 37257017 | Background | Mandal PK, Dwivedi D, Joon S, Goel A, Ahasan Z, Maroon JC, Singh P, Saxena R, Roy RG. Quantitation of Brain and Blood Glutathione and Iron in Healthy Age Groups Using Biophysical and In Vivo MR Spectroscopy: Potential Clinical Application. ACS Chem Neurosci. 2023 Jun 21;14(12):2375-2384. doi: 10.1021/acschemneuro.3c00168. Epub 2023 May 31. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |