NCT02063308已完成不适用
Oxaloacetate Pharmacokinetics and Safety
Russell Swerdlow, MD2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Correlation between oral OAA intake and plasma levels
研究概览
简要总结
By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet criteria for Mild or Moderate AD
- •Have a study partner
- •Speak English as primary language.
排除标准
- •Absence of a study partner
- •Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)
结局指标
主要结局
Correlation between oral OAA intake and plasma levels
时间窗: Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing
Baseline blood sample will be obtained before 100 mg OAA is administered. Blood samples to be drawn every 15 minutes starting 30 minutes after OAA administration.
次要结局
- safety of OAA in study participants(Change from Baseline to Month 1)
研究者
Russell Swerdlow, MD
Gene and Marge Sweeney Professor of Neurology
University of Kansas Medical Center
研究点 (2)
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