RecruitingNot ApplicableNCT06772220

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


Sponsor

Oregon Health and Science University

Enrollment

150 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 40 YearsMax Age: 90 Years

Inclusion Criteria8

  • 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.
  • years of age
  • Estimated glomerular filtration rate ≥60
  • Absence of uncontrolled hypertension in medical history
  • Absence of insulin use

Exclusion Criteria1

  • \-

Interventions

DIETARY_SUPPLEMENTFolic Acid 1 MG

Folic Acid 1mg per day

DIETARY_SUPPLEMENTVitamin B6 25 MG

Vitamin B6, 25mg per day

DIETARY_SUPPLEMENTVitamin B12

Vitamin B12, 1,000 ug per day


Locations(1)

Oregon Health & Science University (OHSU)

Portland, Oregon, United States

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NCT06772220


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