Dopaminergic Enhancement of Learning and Memory (LL_001, Project on Dementia/MCI)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Cognitive performance assessed by neuropsychological tests and learning paradigms under placebo and levodopa in healthy subjects and patients with dementia or Mild Cognitive Impairment.
研究概览
简要总结
This study aims to determine whether levodopa is effective in boosting learning and memory in healthy subjects and patients with dementia or Mild Cognitive Impairment.
We also examine in healthy subjects using functional magnetic resonance imaging which brain regions mediate improved learning after levodopa administration.
详细描述
Prior work of our group shows that the dopamine precursor levodopa markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind trial, we probe whether administration of levodopa improves learning performance as compared to placebo administration on neuropsychological tests and in an associative learning paradigm. We postulate that levodopa improves learning success and memory performance in healthy subjects, while the effect in patients with dementia or Mild Cognitive Impairment might depend on other factors, including severity of memory impairment.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients with dementia:
- •Patients: clinical diagnosis of AD or mild cognitive impairment
- •primary language German
排除标准
- •for healthy subjects and patients with dementia/MCI:
- •Known allergy to levodopa or tetrazine
- •History of medication/drug abuse
- •Acute nicotine withdrawal or > 15 cigarettes per day
- •> 6 cups/glasses of coffee, caffeine drinks or energy drinks per day
- •> 50 grams of alcohol per day
- •Severe hypertonia (systole >160 mm Hg)
- •Severe arteriosclerosis
- •Diabetes, asthma, or glaucoma
- •Severe hearing disability
- •no focal brain lesions
- •Premorbid depression or psychosis
- •Medication with dopamine agonists or antagonists
- •Parkinsonian symptoms
结局指标
主要结局
Cognitive performance assessed by neuropsychological tests and learning paradigms under placebo and levodopa in healthy subjects and patients with dementia or Mild Cognitive Impairment.
Brain activity pattern during learning under levodopa as compared to placebo in healthy subjects.
次要结局
- Long-term stability of learning performance after 1 month in healthy subjects.