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

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Parkinson&Amp;#39;s Disease

Treatments: Dietary Supplement: Vitamin B12; Dietary Supplement: Folic Acid 1 MG; Dietary Supplement: Vitamin B6 25 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT06772220

IRB 25171

PF-CER-979199 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

B vitamin regimen

Experimental group

Description:

Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.

Treatment:

Dietary Supplement: Vitamin B6 25 MG

Dietary Supplement: Folic Acid 1 MG

Dietary Supplement: Vitamin B12

No vitamins

No Intervention group

Description:

No vitamin intervention.