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

NCT06772220 | Recruiting

• 2 other identifiers: IRB 25171PF-CER-979199
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson&Amp;#39;s Disease

Keywords

Parkinson's disease; Parkinson disease; homocysteine

Outcome Measures

Primary Outcomes (3)

• Hyperhomocysteinemia and B vitamin deficiency

  Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia

  baseline measurement

• Hyperhomocysteinemia and B vitamin deficiency

  Plasma folic acid in subjects with vs without hyperhomocysteinemia

  baseline measurement

• Hyperhomocysteinemia and B vitamin deficiency

  Plasma pyridoxine in subjects with vs without hyperhomocysteinemia

  baseline measurement

Secondary Outcomes (2)

• Hyperhomocysteinemia and cognitive assessments

  From enrollment to the end of treatment at 3 months

• Hyperhomocysteinemia and measurement of neurofilament light in plasma

  From enrollment to the end of treatment at 3 months

Study Arms (2)

B vitamin regimen

EXPERIMENTAL

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 vitamins

NO INTERVENTION

No vitamin intervention.

Interventions

Folic Acid 1 MG DIETARY_SUPPLEMENT

Folic Acid 1mg per day

B vitamin regimen

Vitamin B6 25 MG DIETARY_SUPPLEMENT

Vitamin B6, 25mg per day

B vitamin regimen

Vitamin B12 DIETARY_SUPPLEMENT

Vitamin B12, 1,000 ug per day

B vitamin regimen

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• years of age
• Estimated glomerular filtration rate ≥60
• Absence of uncontrolled hypertension in medical history
• Absence of insulin use

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Interventions

Folic Acid; Vitamin B 6; Vitamin B 12

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Joseph Quinn, MD

  Oregon Health & Science University (OHSU)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madeline Armendariz Sullivan

CONTACT

503-501-8478; PDResearch@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OHSU Parkinson Center Director

Model Details: Study participants with elevated homocysteine levels at the first study visit will take B vitamins for 3 months, and then have a follow-up visit. Study participants with normal homocysteine levels at the first study visit will not take the B vitamins, and will also have a follow-up visit 3 months later.

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 13, 2025
• Study Start: March 5, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

US (1)