Parkinson&Amp;#39;s DiseaseNCT06772220
Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
A study testing Folic Acid 1 MG, Vitamin B6 25 MG and Vitamin B12 in people with Parkinson&Amp;#39;s Disease, run by Oregon Health and Science University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Parkinson&Amp;#39;s Disease
- What is being tested?
- Folic Acid 1 MG, Vitamin B6 25 MG and Vitamin B12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
Madeline Armendariz Sullivan, 503-501-8478, PDResearch@ohsu.edu
About this study
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
- Being tested
- Folic Acid 1 MG, Vitamin B6 25 MG, Vitamin B12
- Keywords
- Parkinson's disease, Parkinson disease, homocysteine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Folic Acid 1 MGDietary supplement
Folic Acid 1mg per day
Vitamin B6 25 MGDietary supplement
Vitamin B6, 25mg per day
Vitamin B12Dietary supplement
Vitamin B12, 1,000 ug per day
| Study group | Role | What they receive |
|---|---|---|
| B vitamin regimen | Experimental | Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12. Receives: Dietary Supplement: Folic Acid 1 MG; Dietary Supplement: Vitamin B6 25 MG; Dietary Supplement: Vitamin B12 |
| No vitamins | No intervention | No vitamin intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperhomocysteinemia and B vitamin deficiency
Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia
Measured: baseline measurement
Hyperhomocysteinemia and B vitamin deficiency
Plasma folic acid in subjects with vs without hyperhomocysteinemia
Measured: baseline measurement
Hyperhomocysteinemia and B vitamin deficiency
Plasma pyridoxine in subjects with vs without hyperhomocysteinemia
Measured: baseline measurement
Secondary outcomes (2)
Hyperhomocysteinemia and cognitive assessments
Change in total Braincheck score in subjects with vs without hyperhomocysteinemia
Measured: From enrollment to the end of treatment at 3 months
Hyperhomocysteinemia and measurement of neurofilament light in plasma
Change in plasma neurofilament level in subjects with vs without hyperhomocysteinemia
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start5 Mar 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson&Amp;#39;s DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Quinn, Oregon Health and Science University
- Investigators
- Joseph Quinn, MD, Principal investigator, Oregon Health & Science University (OHSU)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772220
- Sponsor's protocol ID
- IRB 25171
- Other IDs
- PF-CER-979199
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06772220
- Acronym / sponsor ID
- IRB 25171
- Conditions
- Parkinson&Amp;#39;s Disease
- Keywords
- Parkinson's disease, Parkinson disease, homocysteine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| B vitamin regimen | Experimental | Dietary Supplement: Folic Acid 1 MG, Dietary Supplement: Vitamin B6 25 MG, Dietary Supplement: Vitamin B12Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12. |
| No vitamins | No intervention | –No vitamin intervention. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Folic Acid 1 MGFolic Acid 1mg per day | Dietary supplement | B vitamin regimen |
| Vitamin B6 25 MGVitamin B6, 25mg per day | Dietary supplement | B vitamin regimen |
| Vitamin B12Vitamin B12, 1,000 ug per day | Dietary supplement | B vitamin regimen |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joseph Quinn, MD principal investigator
Oregon Health & Science University (OHSU)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Folic Acid 1 MG, Vitamin B6 25 MG and Vitamin B12 in people with Parkinson&Amp;#39;s Disease, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madeline Armendariz Sullivan (503-501-8478, PDResearch@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperhomocysteinemia and B vitamin deficiency (time frame: baseline measurement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.