Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 90
Healthy Volunteers: f
View:
• Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria.
• Currently treated with levodopa at a minimum dose of 300 mg/day
• Montreal Cognitive Assessment (MOCA) ≥15
• Demonstrated capacity to provide informed consent.
• 40-90 years of age
• Estimated glomerular filtration rate ≥60
• Absence of uncontrolled hypertension in medical history
• Absence of insulin use
Locations
United States
Oregon
Oregon Health & Science University (OHSU)
RECRUITING
Portland
Contact Information
Primary
Madeline Armendariz Sullivan
PDResearch@ohsu.edu
503-501-8478
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 150
Treatments
Experimental: B vitamin regimen
Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.
No_intervention: No vitamins
No vitamin intervention.
Related Therapeutic Areas
Sponsors
Leads: Oregon Health and Science University