NCT02931136尚未招募4 期
Early Diagnosis and Early Treatment of Alzheimer's Disease Based on Senile Plaque Imaging
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The average annual conversion rate in patients of MCI due to AD convert to the AD.
研究概览
简要总结
The purpose of this study is based on the Flutemetamol-PET senile plaque imaging to investigate the peripheral blood biochemical and brain MRI imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the MCI due to AD. At the same time, the investigators will study the efficacy and safety of early treatment of MCI due to AD by Huperzine A in 52 weeks.
详细描述
This is a randmized, double-blind, placebo-controll study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •memory complaint, preferably corroborated by a spouse or relative.
- •objective memory impairment.
- •normal general cognitive function.
- •intact activities of daily living.
- •absence of dementia.
- •the positive of brain senile plaque.
排除标准
- •more than two lacuna ischemia (of diameter < 1 cm) as revealed by MRI fluid-attenuated inversion recovery (FLAIR) sequence.
- •other type of dementia except AD
研究组 & 干预措施
Placebo group
Placebo Comparator
The placebo in 52 weeks.
干预措施: Placebo (Drug)
treatment group
Active Comparator
Huperzine A treatment.
干预措施: Huperzine A (Drug)
结局指标
主要结局
The average annual conversion rate in patients of MCI due to AD convert to the AD.
时间窗: 52 weeks
次要结局
未报告次要终点
研究者
xiaoshifu
Director
Shanghai Mental Health Center
研究点 (1)
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