Parkinson&Amp;#39;s Disease
Conditions
Keywords
Parkinson's disease, Parkinson disease, homocysteine
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTFolic Acid 1 MG
Folic Acid 1mg per day
DIETARY_SUPPLEMENTVitamin B6 25 MG
Vitamin B6, 25mg per day
DIETARY_SUPPLEMENTVitamin B12
Vitamin B12, 1,000 ug per day
Sponsors
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria. 2. Currently treated with levodopa at a minimum dose of 300 mg/day 3. Montreal Cognitive Assessment (MOCA) ≥15 4. Demonstrated capacity to provide informed consent. 5. 40-90 years of age 6. Estimated glomerular filtration rate ≥60 7. Absence of uncontrolled hypertension in medical history 8. Absence of insulin use
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hyperhomocysteinemia and B vitamin deficiency | baseline measurement | Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hyperhomocysteinemia and cognitive assessments | From enrollment to the end of treatment at 3 months | Change in total Braincheck score in subjects with vs without hyperhomocysteinemia |
| Hyperhomocysteinemia and measurement of neurofilament light in plasma | From enrollment to the end of treatment at 3 months | Change in plasma neurofilament level in subjects with vs without hyperhomocysteinemia |
Countries
United States
Contacts
Primary ContactMadeline Armendariz Sullivan
Outcome results
None listed