Actively Recruiting

Phase Not Applicable
Age: 40Years - 90Years
All Genders
ID06772220

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

Age: 40Years - 90Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

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Trial Site Locations

Total: 1 location

1

Oregon Health & Science University (OHSU)

Portland, Oregon, United States, 97239

Actively Recruiting

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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

Frequently Asked Questions

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