EUCTR2009-011582-88-IE进行中（未招募）不适用
The differential effects of donepezil and placebo on EEG/ ERP measures and fMRI in mild cognitive impairment and elderly controls - donepezil and placebo on EEG/ ERP measures and fMRI
St James Hospital0 个研究点目标入组 20 人开始时间: 2009年4月15日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •Older controls:
- •1.Aged 55-85 years
- •2.Absence of symptoms of cognitive impairment
- •3.MMSE score of 27 or higher
- •4.Test scores on the neuropsychological battery (see below) that are not more than 1 SD below age-adjusted norms
- •5.If history of alcohol dependence: abstinent for 10 years prior to study
- •6.If on antidepressants: mood stable on same dose for 3 months prior to study(bellow cutoff scores on the Hospital Anxiety and Depression Scale)
- •7.Be MRI compatible as per St James’s Hospital Centre for Advanced Imaging (CAMI)MRI screening form
- •1.Aged 55-85 years
- •2.symptoms of cognitive impairment of at least 6 months
- •3.the diagnosis of not demented (i.e. CDR status of 0 or 0.5)
- •4.must score greater than 1.5 SD below aged norms on at least one of the following:WMS-111 -logical memory,visual reproduction or face recognition
- •5.only include as aMCI delayed measures and not immediate measures
- •6.meet consensus criteria for amnestic MCI (aMCI; Winblad et al,2004)
- •7.If history of alcohol dependence: abstinent for 10 years prior to onset of memory loss and memory loss not related tot alcohol as judged by investigator.
- •8.If on antidepressants: mood stable on same dose for 3 months prior to study(below cutoff scores on the Hospital Anxiety and Depression Scale)
- •9.Be MRI compatible as per St James’s Hospital Centre for Advanced Imaging (CAMI)MRI screening form
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Active medical disease or untreated psychiatric disease
- •2.History of stroke,epilepsy/seizure disorder,heart attack,syncopal,episodes of unexplained loss of consciousness
- •3.History of head injury where:Post-traumatic amnesia greater than 24 hours, CT
- •evidence of brain injury, clinically significant post-traumatic sequealae as judged by investigator or loss of consciousness for more than 1 hour
- •4.History of major psychiatric illness excluding controlled depression
- •5.Currently taking psychotropic medication, benzodiazepines or oral steroids
- •6.History or presence of drug abuse
- •7.Current alcohol dependence/abuse
- •8.Scoring above cut-offs on screening anxiety and depression scales (the Hospital Anxiety and Depression Scale (HADS) depression score >8, anxiety score >8) .
- •9.If English is not their first language.
- •10.Any contraindications to taking donepezil as specified in the Summary of Product Characteristics, including history or presence of asthma and seizures.
- •11.Clinically significant abnormalities on screening ECG, including but not limited to conduction abnormalities or heart rate <55 beats / min as judged by the investigator
- •12.Clinically significant abnormalities on screening laboratory tests as judged by the investigator
- •13. Clinically significant chronic obstructive airways disease and peptic ulcer disease as judged by investigator
研究者
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