NCT01552265已完成不适用
Shanghai Cohort Study on Mild Cognitive Impairment for Early Detection of Alzheimer's Disease
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2012年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Time to Conversion from MCI to "Probable AD Dementia"
研究概览
简要总结
This study was planned 1) to identify individuals with Mild Cognitive Impairment (MCI) who convert to Alzheimer's Disease (AD), and 2) to explore factors associated with the conversion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cognitive concern reflecting a change in cognition reported by the patient or informant or clinician
- •Mini-Mental State Examination (MMSE) scores between 18-30 (inclusive)
- •Clinical Dementia Rating (CDR) =0.5; Memory Box score must be at least 0.5
- •Objective memory loss* as evidenced by Auditory Verbal Learning test (AVLT-HS)
- •Essentially preserved activities of daily living based on Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
- •Not-demented, as defined by '"All-cause Dementia" (see 3.
- •All-cause Dementia)
- •Willing to and able to undergo all test procedures including neuroimaging, and agree to longitudinal follow up
- •Written informed consent for the participation of this study including repeated neuropsychological tests and MRI scans
排除标准
- 未提供
结局指标
主要结局
Time to Conversion from MCI to "Probable AD Dementia"
时间窗: 3 years
次要结局
- Time to Conversion from MCI to "All-cause Dementia"(3 years)
- Changes in Neuropsychological examinations(baseline, annual and 3 years)
- Time to Conversion from MCI to "Possible AD Dementia" or "Probable AD Dementia"(3 years)
- Overall survival(3 years)
- Changes in MRI(baseline, annual and 3 years)
研究者
研究点 (1)
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