Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
Recruiting · NCT06772220 · Interventional (participants receive a specific treatment) · Lead sponsor: Oregon Health and Science University
View the official record on ClinicalTrials.gov →Interventions studied
Folic Acid 1 MGVitamin B12Vitamin B6 25 MG
What this trial is about
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.
Who can take part
Age range
40 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Where it is running
1 location listed across 1 US state.
- Oregon Health & Science University (OHSU) - Portland, Oregon, United States