Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dyslexia)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Boost in training success (percent correct) through levodopa as compared to placebo
研究概览
简要总结
This study aims to determine whether levodopa, in combination with a high frequency training of (grammatical) rules, is effective in boosting learning success in healthy subjects and whether this kind of training in combination with levodopa improves reading and spelling abilities of patients with dyslexia.
详细描述
Prior work by our group shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether daily administration of levodopa, coupled with a training of grammatical rules, improves the training success in healthy adults as compared to placebo administration. In the second step of this study, patients with dyslexia will be trained with the identical protocol. We postulate that the combination of intensive training in language rules and levodopa improves the reading, writing, and spelling abilities of patients with dyslexia.
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
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Right-handedness
- •Age between 18-35 years
- •Primary language: German
排除标准
- •Known allergy to levodopa or tetrazine
- •History of medication/drug abuse
- •Acute nicotine withdrawal or > 10 cigarettes per day
- •>6 cups/glasses of coffee, caffeine drinks or energy drinks per day
- •>50 grams of alcohol per day
- •Hypertonia
- •Arteriosclerosis
- •Diabetes, asthma, or glaucoma
- •Psychiatric disease
- •Neurologic disease
- •Other medication
结局指标
主要结局
Boost in training success (percent correct) through levodopa as compared to placebo
Increased performance on reading, spelling and writing tests in dyslexic patients treated with levodopa as compared to placebo
Boost in training success (reaction times) through levodopa as compared to placebo
次要结局
- Stability of improvements one month post training