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临床试验/EUCTR2021-001788-26-FR
EUCTR2021-001788-26-FR招募中1 期

Interest of adding donepezil to the non-medicinal care pathway recommended in France for Alzheimer's disease: CHOLINE-2 study - CHOLINE-2

Assistance Publique - Hôpitaux de Paris0 个研究点目标入组 120 人开始时间: 2021年5月12日最近更新:

试验速览

阶段
1 期
状态
招募中
入组人数
120

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

性别
All

入选标准

  • - Diagnosis of Alzheimer's disease according to the 2014 IWG-2 criteria.
  • - Covered by social security.
  • - Age = 50 years old.
  • - Lack of legal protection measure (guardianship, curatorship).
  • - MMSE score = 10 on inclusion.
  • - Aß42 in the CSF or abnormal Aß40 / Aß42 ratio according to the local cut-offs of the different centers.
  • - Phosphorylated tau in the CSF abnormal according to the local cut-offs of the different centers.
  • - Presence of a family companion or a person at home who can ensure compliance with treatment in the event of an MMSE score <20.
  • - Sufficient command of the French language for the taking of neuropsychological tests.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 60
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • - Another cause of major neurocognitive disorder.
  • - Cardiological contraindication after possible opinion of a cardiologist, at the initiative of the investigator, in particular bradycardia, presence of 2nd or 3rd degree atrioventricular block.
  • - Previous treatment of symptomatic Alzheimer's disease.
  • - Participation in another intervention research

研究者

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