Managing homocysteine levels in Parkinson's patients on levodopa
Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
This study is testing if giving B vitamins to people with Parkinson's who are taking levodopa can lower their homocysteine levels and improve their thinking skills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Oregon Health and Science University Academic / other |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT06772220 on ClinicalTrials.gov |
What this trial studies
This research investigates the levels of homocysteine in patients with Parkinson's disease who are being treated with levodopa. The study aims to determine if B vitamin therapy can effectively lower elevated homocysteine levels and assess the subsequent effects on cognitive function. Participants will receive folic acid, vitamin B6, and vitamin B12 as part of the intervention. The study focuses on understanding the relationship between homocysteine levels and cognitive health in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40-90 with a diagnosis of probable Parkinson's disease who are currently treated with a minimum of 300 mg/day of levodopa.
Not a fit: Patients with uncontrolled hypertension or those requiring insulin may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve cognitive function and overall health in Parkinson's patients receiving levodopa.
How similar studies have performed: While there is limited data on this specific approach, studies addressing homocysteine management in neurological conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \-
Where this trial is running
Portland, Oregon
- Oregon Health & Science University (OHSU) — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Quinn, MD — Oregon Health & Science University (OHSU)
- Study coordinator: Madeline Armendariz Sullivan
- Email: PDResearch@ohsu.edu
- Phone: 503-501-8478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.