跳至主要内容
临床试验/EUCTR2007-006487-30-IE
EUCTR2007-006487-30-IE进行中(未招募)不适用

Differential Effects of donepezil and placebo in mild cognitive impairment and elderly controls.

St. James's Hospital0 个研究点目标入组 40 人开始时间: 2007年12月6日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion Criteria:
  • Older Controls
  • aged between 65-80 years
  • absence of symptoms of cognitive impairment
  • MMSE score of 27 or higher
  • test scores on the neuropsychological battery (see below) that are not more than 1 SD below age-adjusted norms
  • aMCI Subjects
  • aged between 65-80 years,
  • symptoms of cognitive impairment for at least 6 months,
  • the diagnosis of ‘not demented’ (i.e. CDR status of 0 or 0.5).
  • must score greater than 1.5 SD below aged norms on at least one of the following: WMS-III logical memory, visual reproduction or face recognition
  • only include as aMCI delayed measures and not immediate measures.
  • meet consensus criteria for amnestic MCI (a-MCI; Winblad et al, 2004)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Exclusion Criteria
  • Active medical disease or psychiatric illness
  • History of head injury, stroke, epilepsy/seizure disorder, heart attack, syncopal or pre-syncopal episode, episodes of unexplained loss of consciousness
  • Clinically significant abnormalities on screening ECG, including but not limited to conduction abnormalities or heart rate <55 beats / min as judged by the investigator
  • Clinically significant abnormalities on screening laboratory tests as judged by the investigator
  • History of major psychiatric illness
  • Currently taking psychotropic medication, antidepressants, benzodiazepines or oral steroids.
  • History or presence of alcohol/drug abuse/dependency
  • Scoring above cut-offs on screening anxiety and depression scales (the Hospital Anxiety and Depression Scale (HADS) depression score >8, anxiety score >8 .
  • If English is not their first language
  • Any contraindications to taking donepezil as specified in the Summary of Product Characteristics, including history or presence of asthma, chronic obstructive airways disease, peptic ulcers and seizures.

研究者

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