Screen and Verification of Biomarkers for Early Detection of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Fold changes of proteins in the blood of Patients with MCI over control people.
研究概览
简要总结
Blood will be harvested from three groups of people, normal control, patients with mild cognitive impairment (MCI) and patients with Alzheimer's disease (AD), 20 people per group. The blood samples will be used to determine the difference in the expression of microRNAs and proteins. Blood samples will be harvested again at 6-month interval from patients. The combination of the microRNAs and proteins that have different expression patterns between normal control and patients with MCI will be constructed in a kit to detect the difference. This kit will be used in another set of the three groups of people to determine its sensitivity and specificity in detecting patients with MCI.
详细描述
As discussed above, patients' blood samples will be tested by chip to test microRNA expression and liquid chromatography-mass spectrometry to determine protein expression. The differences in microRNA and protein expression among the three groups, especially between the control and MCI, will be analyzed. This information will be used to construct a kit that can contain probes to detect a few microRNAs or proteins. This kit will be used in another set of patients to check its sensitivity and specificity. The first set of patients will also be followed up every 6 months for up to 1.5 years. Blood samples will be harvested during the follow-ups. The changes in microRNAs and proteins will be correlated with the changes of cognition. This information will be used for constructing the kit as well.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age-matched with patients with MCI group
排除标准
- •With cognitive dysfunction
- •With major cardiovascular diseases, especially stroke and brain transient ischemic attack
- •On steroid treatment
- •with major organ diseases
结局指标
主要结局
Fold changes of proteins in the blood of Patients with MCI over control people.
时间窗: Patients with MCI and AD will be evaluated every 6 month for 1.5 years to monitor the changes in their cognition and the expression patterns of microRNAs and proteins.
serum and plasma will be used in the screen.
Fold changes of microRNAs in the blood of Patients with MCI over control people.
时间窗: Patients with MCI and AD will be evaluated every 6 month for 1.5 years to monitor the changes in their cognition and the expression patterns of microRNAs and proteins.
serum and plasma will be used in the screen.
次要结局
未报告次要终点
研究者
Zhiyi Zuo
Visiting Professor
Sun Yat-sen University