Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT07064005
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C017341', 'term': 'gamma-glutamylcysteine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Changes in brain glutathione levels (mM) in people with Parkinson's Disease using Magnetic Resonance Spectroscopy compared to post-supplementation with GGC.", 'timeFrame': '12 months', 'description': 'MEGA-PRESS is a non-invasive imaging technique, to detect various neurochemical (e.g., Glutathione) using 1H MR spectroscopy.'}, {'measure': "Changes in brain iron levels (ppb) in people with Parkinson's Disease using Magnetic Resonance Imaging between pre and post GGC supplementation.", 'timeFrame': '12 months'}, {'measure': "Changes in baseline blood iron levels(ng/μl) in people with Parkinson's Disease", 'timeFrame': '12 months'}, {'measure': "Changes in baseline blood glutathione levels (µmol/l) in people with Parkinson's Disease compared to post-supplementation with GGC", 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': "Monitor the change in the motor function using Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) pre and post GGC supplementation.", 'timeFrame': '12 months', 'description': '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).\n\nInterpretation: Higher scores indicates greater severity of symptoms.'}, {'measure': 'Cognitive functions modulation- pre and post GGC supplementation using Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).', 'timeFrame': '12 months', 'description': 'Interpretation: Higher scores indicate greater cognitive function.'}, {'measure': "Changes from baseline in the psychological distress using Brief Symptom Inventory (BSI-18) (self-report) in people with Parkinson's Disease.", 'timeFrame': '12 months', 'description': '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.'}, {'measure': "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.", 'timeFrame': '12 months', 'description': 'Scoring Method: Raw Score: 8-40 Interpretation: Lower scores on this measure indicate greater subjective cognitive difficulty.'}, {'measure': "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.", 'timeFrame': '12 months', 'description': 'Scoring Method: The average scores are as follows: • Trail A - 29 seconds • Trail B - 75 seconds Interpretation: Higher scores indicate greater impairment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood', 'Brain', 'MR Spectroscopy', 'GGC', 'Glutathione', 'Parkinsons disease', 'Oxidative stress', 'Brain Iron'], 'conditions': ['Parkinsons Disease (PD)']}, 'referencesModule': {'references': [{'pmid': '24252804', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '38050970', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '37257017', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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:\n\n1. 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.\n2. To study the changes in motor function, cognitive skills in PD patients due to GGC oral supplementation\n3. To study impact of GGC on gut health on the PD patients.", 'detailedDescription': '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.\n\nThe neuropsychological examination and motor function will be performed in pre and post GGC supplementation.\n\nThis study will provide the relation of brain GSH enrichment with motor performance.\n\nOur study will also provide any possible correlation with reduction of dysbiosis of the gut microbiome with GSH enrichment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Confirmed Parkinson's Disease diagnosis.\n* Montreal Cognitive Assessment (MoCA) greater than or equal to 26.\n* Age (50 to 80 years of age).\n* Ability to read and write in English.\n\nExclusion Criteria:\n\n* Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments in the eyes, skin, or body.\n* Subjects with claustrophobia.\n* Patients with a clinical diagnosis of Parkinson's disease dementia or dementia with Lewy bodies.\n* Subjects with a history of cancer.\n* Subjects with active psychosis or delirium.\n* Subjects with chronic kidney (creatinine \\> 1.5mg/dL) or liver disease (AST/ALT \\> 2 upper limit of normal) within 30 days prior to enrolment.\n* Subjects on antioxidant therapy (ashwagandha, gingko biloba or N-acetylcysteine) or illicit drug abuse/dependence (cocaine, heroin, marijuana, or fentanyl).\n* Subjects with previous traumatic head injury."}, 'identificationModule': {'nctId': 'NCT07064005', 'acronym': 'PDGSH', 'briefTitle': "Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkinson's Disease Patients.", 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'STUDY24120097'}, 'secondaryIdInfos': [{'id': '2001', 'type': 'OTHER_GRANT', 'domain': 'Waste Connections INC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gamma - Glutamylcysteine', 'description': 'Patients will receive GGC tablet 400mg orally twice a day (morning and in the afternoon).', 'interventionNames': ['Drug: Gamma- glutamylcysteine']}], 'interventions': [{'name': 'Gamma- glutamylcysteine', 'type': 'DRUG', 'otherNames': ['GGC'], 'description': '400 mg (two times) per day', 'armGroupLabels': ['Gamma - Glutamylcysteine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pravat K Mandal, PhD', 'role': 'CONTACT', 'email': 'mandalpk@pitt.edu', 'phone': '4126999561'}], 'facility': 'UPMC Presbyterian Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Pravat K MANDAL, PHD', 'role': 'CONTACT', 'email': 'mandalpk@pitt.edu', 'phone': '4126999561'}, {'name': 'Nazia Pillar, M.S', 'role': 'CONTACT', 'email': 'naa430@pitt.edu', 'phone': '878-670-3123'}], 'overallOfficials': [{'name': 'Pravat K Mandal, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'The IPD report will be accessible starting 6 months after publication of the main results.', 'ipdSharing': 'YES', 'description': '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pravat Mandal', 'class': 'OTHER'}, 'collaborators': [{'name': 'Waste Connections Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Assistant Professor', 'investigatorFullName': 'Pravat Mandal', 'investigatorAffiliation': 'University of Pittsburgh'}}}}