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NCT Number: NCT06772220

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

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.

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Key information

Conditions

Parkinson&Amp;#39;s Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Madeline Armendariz Sullivan

CONTACT

[email protected]

503-501-8478

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

-

Treatment and study plan

Folic Acid 1 MG

Dietary Supplement

Folic Acid 1mg per day

Vitamin B6 25 MG

Dietary Supplement

Vitamin B6, 25mg per day

Vitamin B12

Dietary Supplement

Vitamin B12, 1,000 ug per day

Primary outcomes

  1. Hyperhomocysteinemia and B vitamin deficiency

    Time frame: baseline measurement

    Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia

  2. Hyperhomocysteinemia and B vitamin deficiency

    Time frame: baseline measurement

    Plasma folic acid in subjects with vs without hyperhomocysteinemia

  3. Hyperhomocysteinemia and B vitamin deficiency

    Time frame: baseline measurement

    Plasma pyridoxine in subjects with vs without hyperhomocysteinemia

Secondary outcomes

  1. Hyperhomocysteinemia and cognitive assessments

    Time frame: From enrollment to the end of treatment at 3 months

    Change in total Braincheck score in subjects with vs without hyperhomocysteinemia

  2. Hyperhomocysteinemia and measurement of neurofilament light in plasma

    Time frame: From enrollment to the end of treatment at 3 months

    Change in plasma neurofilament level in subjects with vs without hyperhomocysteinemia

Study contacts

Contact information is provided by the study sponsor or research team.

Madeline Armendariz Sullivan

CONTACT

[email protected]

503-501-8478

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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