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| ID | Type | Description | Link |
|---|---|---|---|
| PF-CER-979199 | Other Grant/Funding Number | Parkinson's Foundation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B vitamin regimen | Experimental | Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12. |
|
| No vitamins | No Intervention | No vitamin intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Folic Acid 1 MG | Dietary Supplement | Folic Acid 1mg per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperhomocysteinemia and B vitamin deficiency | Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia | baseline measurement |
| Hyperhomocysteinemia and B vitamin deficiency | Plasma folic acid in subjects with vs without hyperhomocysteinemia | baseline measurement |
| Hyperhomocysteinemia and B vitamin deficiency | Plasma pyridoxine in subjects with vs without hyperhomocysteinemia | baseline measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Hyperhomocysteinemia and cognitive assessments | Change in total Braincheck score in subjects with vs without hyperhomocysteinemia | From enrollment to the end of treatment at 3 months |
| Hyperhomocysteinemia and measurement of neurofilament light in plasma |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Madeline Armendariz Sullivan | Contact | 503-501-8478 | PDResearch@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joseph Quinn, MD | Oregon Health & Science University (OHSU) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University (OHSU) | Recruiting | Portland | Oregon | 97239 | United States |
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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 |
|---|---|
| D005492 | Folic Acid |
| D025101 | Vitamin B 6 |
| D014805 | Vitamin B 12 |
| ID | Term |
|---|---|
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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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.
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| Vitamin B6 25 MG |
| Dietary Supplement |
Vitamin B6, 25mg per day |
|
| Vitamin B12 | Dietary Supplement | Vitamin B12, 1,000 ug per day |
|
Change in plasma neurofilament level in subjects with vs without hyperhomocysteinemia |
| From enrollment to the end of treatment at 3 months |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006571 | Heterocyclic Compounds |
| D010847 | Picolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D045728 | Corrinoids |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |