NCT06772220 · Oregon Health and Science University
Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
What this study is about
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.
View original scientific description
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
Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia
Hyperhomocysteinemia and B vitamin deficiency
Time frame: baseline measurement
Plasma folic acid in subjects with vs without hyperhomocysteinemia
Hyperhomocysteinemia and B vitamin deficiency
Time frame: baseline measurement
Plasma pyridoxine in subjects with vs without hyperhomocysteinemia
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Portland, Oregon
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 13, 2025 · Source of record for eligibility and locations