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

Not Applicable

Recruiting

• Conditions: Parkinson&Amp;#39;s Disease

• Registration Number: NCT06772220
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-05
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hyperhomocysteinemia and B vitamin deficiency	baseline measurement	Plasma pyridoxine in subjects with vs without hyperhomocysteinemia

Secondary Outcome Measures

Name	Time	Method
Hyperhomocysteinemia and cognitive assessments	From enrollment to the end of treatment at 3 months	Change in total Braincheck score in subjects with vs without hyperhomocysteinemia
Hyperhomocysteinemia and measurement of neurofilament light in plasma	From enrollment to the end of treatment at 3 months	Change in plasma neurofilament level in subjects with vs without hyperhomocysteinemia

Trial Locations

Locations (1)

Oregon Health & Science University (OHSU); 🇺🇸 Portland, Oregon, United States