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
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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