Actively Recruiting
Pilot Study of Open Label B Vitamin Therapy to Manage Homocysteine Levels in Levodopa-Treated Parkinson's Disease
Led by Oregon Health and Science University · Updated on 2025-01-13
150
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating elevated homocysteine levels in the blood of patients with Parkinson's disease who are currently treated with levodopa. The study aims to evaluate whether open label B vitamin therapy can correct elevated homocysteine and to understand how homocysteine levels affect cognitive function in these patients. This pilot study focuses on participants aged 40 to 90 years with Parkinson's disease meeting specific clinical criteria. Participants will take daily supplements of folic acid (1 mg), vitamin B6 (25 mg), and vitamin B12 (1,000 ug) as part of the open label homocysteine management therapy. The study monitors homocysteine and B vitamin deficiency levels at baseline to assess treatment impact. The intervention involves dietary supplements given daily, with the goal of correcting elevated homocysteine associated with levodopa treatment. Throughout the study, participants will undergo cognitive assessments including the Montreal Cognitive Assessment (MOCA) and laboratory tests to measure homocysteine and kidney function (glomerular filtration rate). Researchers will evaluate the ability to provide informed consent and monitor blood pressure and insulin use history to ensure safety. The study focuses on the relationship between homocysteine management and cognitive function during the treatment period.
CONDITIONS
Official Title
Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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) score of 15 or higher
- Ability to provide informed consent
- Age between 40 and 90 years
- Estimated glomerular filtration rate of 60 or higher
- No history of uncontrolled hypertension
- Not using insulin
You will not qualify if you...
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
M
Madeline Armendariz Sullivan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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