Immunohistochemical Study of Peripheral Blood Mononuclear Cells in Sporadic Alzheimer's Disease and Dementia With Lewy Body
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Immunerepertorie
研究概览
简要总结
The subject uses cytof to analyze PBMC of sporadic AD and DLB, which is used to reveal the differences in immune characteristics of the two diseases at the single-cell level, build immune models for specific diseases, and define these two neurodegenerative diseases with high precision from the level of molecular immunity. To provide basis for further study of the immunohistochemical differences between the two diseases, and provide objective support for clinical diagnosis and differential diagnosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AD inclusion criteria:
- •a.Clinical diagnosis of Alzheimer's Disease
- •DLB inclusion criteria:
- •Clinical diagnosis of Dementia with Lewy bodies
排除标准
- •Infectious diseases
- •autoimmune disease
- •heart failure
- •chronic obstructive pulmonary disease (COPD)
- •renal failure
- •recently major surgery
- •alcohol and / or drug abuse
- •disturbance of consciousness
- •clinical diagnosis of major depression disorder
- •clinical diagnosis of Anxiety disorder
研究组 & 干预措施
AD group
20 subjects who met the diagnostic criteria and exclusion criteria of AD were included in the discovery cohort.
干预措施: Detection of cytof in peripheral PBMC (Biological)
AD group
20 subjects who met the diagnostic criteria and exclusion criteria of AD were included in the discovery cohort.
干预措施: Donepezil for patients with AD and DLB (Drug)
DLB group
Of the 30 subjects who met the DLB diagnostic criteria and exclusion criteria, 20 were included in the discovery cohort and 10 in the validation cohort.
干预措施: Detection of cytof in peripheral PBMC (Biological)
DLB group
Of the 30 subjects who met the DLB diagnostic criteria and exclusion criteria, 20 were included in the discovery cohort and 10 in the validation cohort.
干预措施: Donepezil for patients with AD and DLB (Drug)
Healthy control group
Among the 30 subjects who met the diagnostic and exclusion criteria of the healthy control group, 20 were included in the discovery cohort and 10 in the validation cohort.
干预措施: Detection of cytof in peripheral PBMC (Biological)
结局指标
主要结局
Immunerepertorie
时间窗: 1 year
The immune cells were drawn into immunoreceptor by mass cytometry (cytof) technology. Immunerepertorie is used for the classification of immune cells. According to the proportion of various immune cell subtypes and biomarkers in all cells, it is used to find the difference between immune cell subtypes and biomarkers in different diseases. Scoring frame: 0-1. The higher the score, the greater the proportion of this subtype or biomarker.
immunological Elastic-Net (iEN) model
时间窗: 1 year
The immunological Elastic-Net (iEN), which incorporates immunological knowledge directly into the predictive models. The ROC curve output by the model is plotted with specificity as the abscissa and sensitivity as the ordinate, and the AUC (area under the curve) value is calculated. The AUC value was used to evaluate the authenticity of the IEN model. Score frame: 0.5-1. A higher value indicates that the model is closer to the real situation.
次要结局
- Mini-mental State Examination（MMSE）(1 year)
研究者
Hu ShaoHua
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
First Affiliated Hospital of Zhejiang University