EUCTR2005-004283-23-GB进行中（未招募）1 期
An evaluation of potential therapies to inhibit cerebral emboli in dementia - Therapies to inhibit cerebral emboli in dementia
South Manchester University Hospital0 个研究点目标入组 220 人开始时间: 2005年11月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
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
入选标准
- •. Dementia - patients must fulfill DSM IV criteria for dementia (Diagnostic and Statistic Manual of Mental Disorders 1995)
- •. AD - patients must fulfill the NINCDS-ADRDA criteria (McKhann G et al 1984)
- •. VaD - patients must fulfill the NINCDS-AIREN criteria (Roman G D et al 1993)
- •. Patient must have an identified carer who can manage any trial medication
- •No evidence of cognitive impairment or any other significant health impairment which might interfere with their participation.
- •American Psychiatric Association. Diagnoswtic and Statistical Manual of Mental Disorders. 1995. Fourth Edition. AMA, Washington DC.
- •McKhann G et al. Clinical Diagnosis of Alzheimer's disease: Report of the NINCSA-ADRDA work Group under the auspices of the Department of Health and Human Services Task Force of Alzheimer's disease. Neurology 1984;34:939-944.
- •Roman GD et al. Vascular dementia: Diagnostic criteria for research studies. Report of the NINDS-Airen International Workshop. Neurology 1993;43(February):250-260.
- •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
- •. Patients with a Mini-Mental State Examination (MMSE) (Folstein et al 1975, Molloy et al 1991) score of <10 and/or severe aphasia (as the study requires considerable co-opoeration)
- •. Current anticoagulant treatment (may reduce spontaneous emboli)
- •. Diagnosed as suffering from AF
- •Folstein MF, Folstein SE, McHugh PR. Mini-mental state. A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research 1975 Nov;12(3):189-98
- •Molloy DW, Alemayehu E, Roberts R. A standardised Mini-Mental State Examination (MMSE). American Journal of Psychiatry 1991;148 p102-105.
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