Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in CNS Vitals Composite Score
研究概览
简要总结
Pilot studies in healthy volunteers and in patients with epilepsy to assess the potential efficacy and safety of different dosages of vinpocetine in improving cognition.
详细描述
Cognitive problems are common in patients with epilepsy, but there is currently no specific treatment available. Vinpocetine is a chemical obtained from the leaves of the Lesser Periwinkle. It has been shown to improve cerebral metabolism and memory in animals and humans. In addition, it has been shown to enhance long-term potentiation, which has been linked to memory mechanisms. Furthermore, vinpocetine has been shown to have anticonvulsant effects and is more potent than several commonly used antiepileptic drugs (i.e., carbamazepine, phenytoin, valproate, oxcarbazepine, lamotrigine and topiramate) in inhibiting both sodium and calcium channels, which control release of excitatory neurotransmitters that can lead to brain injury. Thus, vinpocetine might offer a unique drug to help cognition in patients with epilepsy. The investigators propose to conduct pilot studies in healthy volunteers and in patients with epilepsy to assess the potential efficacy and safety of different dosages of vinpocetine in improving cognition.
Specific Aim 1a: To determine if vinpocetine enhances memory and other cognitive functions in healthy volunteers.
Specific Aim 1b: To determine blood levels from 3 different acute oral doses of vinpocetine in healthy volunteers.
Specific Aim 2a: To provide safety and preliminary of efficacy data that vinpocetine can enhance memory and other cognitive functions in patients with epilepsy.
Specific Aim 2b: To determine blood levels from acute and chronic oral doses of vinpocetine in patients with epilepsy as well as effects on anticonvulsant blood levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low dose
Vinpocetine 10 mg Healthy subjects
干预措施: Vinpocetine (Drug)
Mid-dose 1
Vinpocetine 20mg Healthy subjects
干预措施: Vinpocetine (Drug)
Placebo
0 dose of vinpocetine Healthy and Epilepsy subjects
干预措施: Vinpocetine (Drug)
High Dose
Vinpocetine 60 mg single dose Healthy Subjects & 20mg tid Epilepsy Subjects
干预措施: Vinpocetine (Drug)
结局指标
主要结局
Change in CNS Vitals Composite Score
时间窗: Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12
CNS Vitals consists of multiple subtasks that provide an overall composite score will be the primary outcome measure
次要结局
- Adverse Events(Healthy - weekly treatment visits 1-4; Epilepsy =treatment weeks 4, 8, & 12)
研究者
Kimford Jay Meador
Professor
Stanford University
