Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-21 @ 3:50 PM
Study NCT ID:
NCT06772220
Status:
RECRUITING
Last Update Posted:
2025-01-13
First Post:
2025-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
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': 'D005492', 'term': 'Folic Acid'}, {'id': 'D025101', 'term': 'Vitamin B 6'}, {'id': 'D014805', 'term': 'Vitamin B 12'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010847', 'term': 'Picolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D045728', 'term': 'Corrinoids'}, {'id': 'D045725', 'term': 'Tetrapyrroles'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study participants with elevated homocysteine levels at the first study visit will take B vitamins for 3 months, and then have a follow-up visit. Study participants with normal homocysteine levels at the first study visit will not take the B vitamins, and will also have a follow-up visit 3 months later.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2025-01-02', 'studyFirstSubmitQcDate': '2025-01-08', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hyperhomocysteinemia and B vitamin deficiency', 'timeFrame': 'baseline measurement', 'description': 'Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia'}, {'measure': 'Hyperhomocysteinemia and B vitamin deficiency', 'timeFrame': 'baseline measurement', 'description': 'Plasma folic acid in subjects with vs without hyperhomocysteinemia'}, {'measure': 'Hyperhomocysteinemia and B vitamin deficiency', 'timeFrame': 'baseline measurement', 'description': 'Plasma pyridoxine in subjects with vs without hyperhomocysteinemia'}], 'secondaryOutcomes': [{'measure': 'Hyperhomocysteinemia and cognitive assessments', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Change in total Braincheck score in subjects with vs without hyperhomocysteinemia'}, {'measure': 'Hyperhomocysteinemia and measurement of neurofilament light in plasma', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'Change in plasma neurofilament level in subjects with vs without hyperhomocysteinemia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Parkinson's disease', 'Parkinson disease', 'homocysteine'], 'conditions': ['Parkinson&Amp;#39;s Disease']}, 'descriptionModule': {'briefSummary': "This is a research study investigating elevated homocysteine in the blood of patients with Parkinson's disease who are currently receiving treatment with levodopa. We are evaluating if elevated homocysteine can be corrected using open label B vitamin therapy, as well as the impact of homocysteine levels on cognitive function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria.\n2. Currently treated with levodopa at a minimum dose of 300 mg/day\n3. Montreal Cognitive Assessment (MOCA) ≥15\n4. Demonstrated capacity to provide informed consent.\n5. 40-90 years of age\n6. Estimated glomerular filtration rate ≥60\n7. Absence of uncontrolled hypertension in medical history\n8. Absence of insulin use\n\nExclusion Criteria:\n\n\\-"}, 'identificationModule': {'nctId': 'NCT06772220', 'briefTitle': "Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': "Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease", 'orgStudyIdInfo': {'id': 'IRB 25171'}, 'secondaryIdInfos': [{'id': 'PF-CER-979199', 'type': 'OTHER_GRANT', 'domain': "Parkinson's Foundation"}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B vitamin regimen', 'description': 'Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.', 'interventionNames': ['Dietary Supplement: Folic Acid 1 MG', 'Dietary Supplement: Vitamin B6 25 MG', 'Dietary Supplement: Vitamin B12']}, {'type': 'NO_INTERVENTION', 'label': 'No vitamins', 'description': 'No vitamin intervention.'}], 'interventions': [{'name': 'Folic Acid 1 MG', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Folic Acid 1mg per day', 'armGroupLabels': ['B vitamin regimen']}, {'name': 'Vitamin B6 25 MG', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin B6, 25mg per day', 'armGroupLabels': ['B vitamin regimen']}, {'name': 'Vitamin B12', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Vitamin B12, 1,000 ug per day', 'armGroupLabels': ['B vitamin regimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Madeline Armendariz Sullivan', 'role': 'CONTACT', 'email': 'PDResearch@ohsu.edu', 'phone': '503-501-8478'}], 'facility': 'Oregon Health & Science University (OHSU)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Madeline Armendariz Sullivan', 'role': 'CONTACT', 'email': 'PDResearch@ohsu.edu', 'phone': '503-501-8478'}], 'overallOfficials': [{'name': 'Joseph Quinn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oregon Health & Science University (OHSU)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'OHSU Parkinson Center Director', 'investigatorFullName': 'Joseph Quinn', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}