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RecruitingNCT06772220Updated Jan 13, 2025

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

An interventional study of Folic Acid 1 MG and Vitamin B6 25 MG in Parkinson&Amp;#39;s Disease, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-01-13.

Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Registered 9 months after the study started (first participant enrolled Mar 2024, registered Jan 2025).
  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
40 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson&Amp;#39;s Disease

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Keywords

  • Parkinson's disease
  • Parkinson disease
  • homocysteine
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 150 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    B vitamin regimen

    Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.

    Dietary Supplement: Folic Acid 1 MG · Dietary Supplement: Vitamin B6 25 MG · Dietary Supplement: Vitamin B12

  • No intervention
    No vitamins

    No vitamin intervention.

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

06

What researchers measure

Primary outcomes

  1. Hyperhomocysteinemia and B vitamin deficiency

    Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia

    Time frame: baseline measurement

  2. Hyperhomocysteinemia and B vitamin deficiency

    Plasma folic acid in subjects with vs without hyperhomocysteinemia

    Time frame: baseline measurement

  3. Hyperhomocysteinemia and B vitamin deficiency

    Plasma pyridoxine in subjects with vs without hyperhomocysteinemia

    Time frame: baseline measurement

Secondary outcomes

  1. Hyperhomocysteinemia and cognitive assessments

    Change in total Braincheck score in subjects with vs without hyperhomocysteinemia

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

  2. Hyperhomocysteinemia and measurement of neurofilament light in plasma

    Change in plasma neurofilament level in subjects with vs without hyperhomocysteinemia

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

07

Study locations

1 of 1 sites recruiting
  • Oregon Health & Science University (OHSU)
    Portland, Oregon 97239, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06772220
Lead sponsor
Oregon Health and Science University
Responsible party
Joseph Quinn (OHSU Parkinson Center Director, Oregon Health and Science University) — Principal investigator
First posted
Jan 13, 2025
Start date
Mar 5, 2024
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jan 13, 2025

Study contacts

Madeline Armendariz Sullivan
Contact
PDResearch@ohsu.edu
503-501-8478
Joseph Quinn, MD
principal investigator · Oregon Health & Science University (OHSU)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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