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

January 8, 2025 updated by: Joseph Quinn, Oregon Health and Science University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University (OHSU)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Folic Acid 1mg per day
Dietary supplement: Vitamin B6 25 MG
Vitamin B6, 25mg per day
Dietary supplement: Vitamin B12
Vitamin B12, 1,000 ug per day
No Intervention: No vitamins
No vitamin intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hyperhomocysteinemia and B vitamin deficiency
Time Frame: baseline measurement
Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia
baseline measurement
Hyperhomocysteinemia and B vitamin deficiency
Time Frame: baseline measurement
Plasma folic acid in subjects with vs without hyperhomocysteinemia
baseline measurement
Hyperhomocysteinemia and B vitamin deficiency
Time Frame: baseline measurement
Plasma pyridoxine in subjects with vs without hyperhomocysteinemia
baseline measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of treatment at 3 months
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
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Investigators

  • Principal Investigator: Joseph Quinn, MD, Oregon Health & Science University (OHSU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB 25171
  • PF-CER-979199 (Other Grant/Funding Number: Parkinson's Foundation)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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