A Single-blinded Assessment of the Short-term Effects of Cabergoline vs. Carbidopa/Levodopa on SPECT Dopamine Transporter Density in Out-patient Subjects With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 17
- 主要终点
- To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease
研究概览
简要总结
This study investigates whether there is a change in 123iodine-2ß- carbomethoxy-3ß-(4-iodophenyl) tropane ([123I]ß-CIT) uptake after short-term treatment with levodopa compared to either dopamine agonist or placebo.
详细描述
This is a multi-center, open-label study of short-term treatment with levodopa or cabergoline on striatal DATscan uptake in early Parkinson's disease. Approximately 120 Parkinson's disease subjects will be randomized to receive either carbidopa/levodopa, cabergoline or no treatment during a twelve week period. Subjects will undergo SPECT imaging with DATscan at screening and after 12 weeks. After twelve weeks carbidopa/levodopa and cabergoline treatment will be withdrawn and all subjects will undergo SPECT imaging with DATscan after 8 weeks (20 weeks after baseline).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is aged 40 years or older.
- •Written informed consent is obtained.
- •Subjects have a clinical diagnosis of idiopathic Parkinson's disease.
- •Hoehn and Yahr stages for subjects are I-II.
排除标准
- •The subject has atypical or drug-induced Parkinson's disease.
- •The subject has dementia.
- •The subject has clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
- •The subject is pregnant.
结局指标
主要结局
To determine the influence of short-term levodopa therapy on dopamine transporter density in early Parkinson's disease
时间窗: 1 year
次要结局
- To further develop the AMADEUS consortium, a collaboration of clinical-imaging SPECT DAT sites able to obtain data using comparable techniques and transmit imaging to a central analysis site(2 years)
- To determine the influence of short-term treatment with cabergoline on dopamine transporter density in early Parkinson's disease(1 year)