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.
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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