Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Hyperhomocysteinemia and B vitamin deficiency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
No vitamins
No vitamin intervention.
B vitamin regimen
Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.
干预措施: Vitamin B12 (Dietary Supplement)
B vitamin regimen
Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.
干预措施: Folic Acid 1 MG (Dietary Supplement)
B vitamin regimen
Daily doses of 1mg folic acid, 25mg vitamin B6, and 1,000 ug vitamin B12.
干预措施: Vitamin B6 25 MG (Dietary Supplement)
结局指标
主要结局
Hyperhomocysteinemia and B vitamin deficiency
时间窗: baseline measurement
Plasma vitamin B12 in subjects with vs without hyperhomocysteinemia
次要结局
- Hyperhomocysteinemia and cognitive assessments(From enrollment to the end of treatment at 3 months)
- Hyperhomocysteinemia and measurement of neurofilament light in plasma(From enrollment to the end of treatment at 3 months)
研究者
Joseph Quinn
OHSU Parkinson Center Director
Oregon Health and Science University