ISRCTN89039808已完成2 期
Efficacy and safety of three doses of S 38093 (2, 5 and 20 mg/day) versus placebo in patients with mild to moderate Alzheimer's disease
Institut de Recherches Internationales Servier (France)0 个研究点目标入组 711 人开始时间: 2011年7月28日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 711
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
- •1. Age 55-85 years
- •2. School education more than or equal to 4 years
- •3. Able to perform neuropsychological tests
- •4. Have adequate visual and auditory acuity with the usual corrective aids to allow neuropsychological testing
- •5. Have a responsible informant Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for Dementia of the Alzheimer's type
- •6. National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable Alzheimer's disease (AD)
- •7. Mini-Mental State Examination (MMSE) between 15 and 24
排除标准
- •1. Inpatients
- •2. Female patients of child-bearing potential
- •3. Dementia due to any condition other than AD
- •4. History of epilepsy or solitary seizure
- •5. History or presence of Parkinson's disease or Parkinsonism
- •6. Major neurological or neurodegenerative conditions associated with significant cognitive impairment such as Multiple Sclerosis or Huntington's Disease
- •7. Major psychiatric conditions
研究者
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