跳至主要内容
临床试验/NCT03141944
NCT03141944已完成不适用

Improvement of Hypodopaminergic Syndrome With Dopaminergic Treatment in Early Parkinson's Disease

University Hospital, Grenoble4 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2017年2月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
4
主要终点
Evolution of apathy in Parkinson's disease

研究概览

简要总结

The objective of this study is to describe the evolution of hypodopaminergic syndrome in patients with Parkinson's disease.

详细描述

All patients to be included have been clinically described in the early phase of their disease, before instauration of dopaminergic treatment, in the context of a former study ("Non Motor Aspects in De Novo Parkinson's Disease (Honeymoon) NCT02786667") between june 2012 and june 2016.

3 to 5 years after this study, those patients who started dopaminergic treatment will be evaluated again.

The objective of this study, which takes place 3 to 5 year after the initial evaluation, is to measure the evolution of apathy and other symptoms of the hypodopaminergic syndrome.

Secondary objectives are the evolution of other parameters including pain, personality and behavior. All parameters measured have been determined of each patient in the Honeymoon study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
33 Years 至 72 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients who participated in "Non Motors Aspects in De Novo Parkinson's Disease (Honeymoon)" NCT02786667
  • •Patients under dopaminergic treatment, with stable dopaminergic treatment for at least 2 months
  • •Patients with medical insurance
  • •signed informed consent

排除标准

  • •diagnosis other than Parkinson's Disease
  • •dementia (Mattis <130)
  • •patients protected by law (i.e. pregnant or parturient women)

结局指标

主要结局

Evolution of apathy in Parkinson's disease

时间窗: 1day

Evolution of apathy in Patients with Parkinson's disease under dopaminergic treatment. The degree of apathy is evaluated with the "Starkstein Scale of Apathy".

次要结局

  • Evolution of quality of life in Parkinson's disease(1 day)
  • Evolution of eating behavior in Parkinson's disease(1 day)
  • Evolution of impulsivity in Parkinson's disease(1 day)
  • Evolution of personality in Parkinson's disease(1 day)
  • Evolution of somnolence in Parkinson's disease(1 day)
  • Evolution of hypodopaminergia in Parkinson's disease(1 day)
  • Apparition of hyperdopaminergic symptoms in Parkinson's disease(1 day)
  • Evolution of pain in Parkinson's disease(1 day)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (4)

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