Recruiting NCT06772220
Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Folic Acid 1 MG, Vitamin B6 25 MG, Vitamin B12.
- Who it may be relevant to
- Registry conditions: Parkinson&Amp;#39;s Disease. Basic parameters: 40 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Hyperhomocysteinemia and B vitamin deficiency [Time frame: baseline measurement]
- Hyperhomocysteinemia and B vitamin deficiency [Time frame: baseline measurement]
- Hyperhomocysteinemia and B vitamin deficiency [Time frame: baseline measurement]
Secondary outcome measures (2)
- Hyperhomocysteinemia and cognitive assessments [Time frame: 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]
Eligibility criteria
Inclusion criteria
- 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.
- 40-90 years of age
- Estimated glomerular filtration rate ≥60
- Absence of uncontrolled hypertension in medical history
- Absence of insulin use
Exclusion criteria
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Health & Science University (OHSU) — Portland
Identifiers
NCT: NCT06772220 · IRB 25171 · PF-CER-979199