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NCT06772220 | RECRUITING | Parkinson&Amp;#39;s Disease

Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
Sponsor:

Oregon Health and Science University

Information provided by (Responsible Party):

Joseph Quinn

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.

Condition or disease

Parkinson&Amp;#39;s Disease

Intervention/treatment

Folic Acid 1 MG

Vitamin B6 25 MG

Vitamin B12

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 150 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
Actual Study Start Date : 2024-03-05
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
  • \-
Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease

Location Details

NCT06772220

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Oregon

Oregon Health & Science University (OHSU)

Portland, Oregon, United States, 97239