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临床试验/NCT00750529
NCT00750529已完成1 期

Effects of Galantamine and Donépézil on the Amount and the Quality oh the Sleep in Patients Suffering From Alzheimer Disease.

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2008年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil

研究概览

简要总结

The aim of the study is the analysis of two inhibitors of Ach-E: galantamine and donépézil in over 65 years' old patients suffering from Alzheimer disease (MMSE between 20 and 26) without Alzheimer's medication.

详细描述

Feasibility study, open, randomized, controlled, cross-over study in 65 years old patients.

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
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 and over years old
  • Patients suffering from Alzheimer disease
  • Patient living with someone at home
  • Written consent given

排除标准

  • Galantamine or Donepezil hypersensibility
  • Patient living alone and in a medicalized structure
  • Concomitant medication
  • Chronical diseases

研究组 & 干预措施

Galantamine

Experimental

干预措施: Galantamine and Donepezil (Drug)

结局指标

主要结局

Comparison of the percentage of paradoxical sleep recorded with polysomonography in 65 years old patients with administration of Galantamine or Donépézil

时间窗: administration of galantamine or donépézil

次要结局

  • Describe the iatrogenic modifications of rhythm and architecture of sleep. describe the iatrogenic modifications of rythm and architecture of sleep(during the iatrogenic modifications)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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