Non Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
研究概览
简要总结
Clinical description and pathophysiological study of recently diagnosed untreated patients with Parkinson's Disease.
Effect of a dopamine agonist (rotigotine) on apathy in de novo patients with Parkinson disease: A controlled, randomized, double blind study.
详细描述
This study aims to show the impact of a treatment with a D2/D3 receptor-specific dopamine agonist on the hypo-dopaminergic syndrome and quality of life of patients with de-novo Parkinson's disease.
The study consists of three parts:
- The first part consists of a detailed clinical description of these patients, focusing on neuropsychological symptoms. The objective is to describe patients with and without apathy and hypo-dopaminergic syndrome.
- From this population, a small number of patients with and without hypo-dopaminergic syndrome will be selected in order to compare serotoninergic and dopaminergic denervation by positron emission tomography (PET).
- In patients with hypo-dopaminergic syndrome the motivational effects of a dopamine agonist will be tested in a randomized, double-blind, placebo-controlled study.
We hypothesize a significant improvement of apathy in the rotigotine group versus placebo
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson disease without treatment for Parkinson disease
- •Recent diagnosis (< 2 years)
- •Without cognitive troubles
排除标准
- •Patients with cognitive troubles
- •Treated patients with L-Dopa or Dopamine agonists
- •Other severe illness
- •Pregnant or parturient woman
研究组 & 干预措施
Rotigotine
6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
干预措施: Rotigotine (Drug)
Placebo
6 months treatment with Placebo up to 8 mg per day with a titration period for one month
干预措施: Placebo (Drug)
结局指标
主要结局
Change of LARS (Lille Apathy Rating Scale) score in the rotigotine versus placebo group
时间窗: 6 months
次要结局
未报告次要终点