Health TrialsbyHealthPanel

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

ConditionParkinson&Amp;#39;s Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-90
SponsorOregon Health and Science University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: B vitamin regimenExperimental treatment 3 interventions
Group B: No vitaminsNo intervention 0 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Source ClinicalTrials.gov
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