A Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
研究概览
简要总结
The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and complete two safety follow-up phone calls over a 4 month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent and follow instructions per the protocol
- •Diagnosis of idiopathic PD within 7 years of diagnosis
- •Taking stable doses of levodopa and would not predictably need adjustment in PD medications for 4 months
- •Unified Parkinson's Disease Rating Scale (UPDRS) II + III at least 30 points at baseline
排除标准
- •Previously taken Oxaloacetate
- •Participation in other drug studies or use of other investigational products within 30 days prior to baseline
- •In the Investigator's opinion, any unstable or clinically significant condition that would impair the subjects' ability to comply with study follow-up
- •Other known or suspected cause of parkinsonism
研究组 & 干预措施
Oxaloacetate (OAA)
active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily
干预措施: Oxaloacetate (OAA) (Drug)
Placebo
placebo capsules that contain only 100 mg ascorbate, taken daily
干预措施: Placebo (Drug)
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
时间窗: 4 months
The UPDRS has 3 subscales including Mentation (4 questions based on patient report with answers on a scale of 0-4, with a total of 16 points), Activities of Daily Living (13 questions based on patient report with answers on a scale of 0-4, with a total of 52 points) and Motor (27 questions based on clinician assessment on a scale of 0-4, with a total of 108 points). The total scores represents the sum of each of these sections for a total of 176 points with a higher score representing greater dysfunction.
次要结局
- Geriatric Depression Scale (GDS)(4 months)
- Unified Parkinson's Disease Rating Scale (UPDRS) ADL + Motor Score(4 months)
- NonMotor Symptom Questionnaire (NMSQuest)(4 months)
- Parkinson's Disease Questionnaire - 39 (PDQ-39)(4 months)
- Montreal Cognitive Assessment (MoCA)(4 months)
研究者
Rajesh Pahwa, MD
Professor, Director PD and Movement Disorder Center
University of Kansas Medical Center