Immunohistochemical Study of Neurodegenerative Diseases
- Conditions
- Alzheimer DiseaseLewy Body DiseaseNeurodegenerative Diseases
- Interventions
- Biological: Detection of cytof in peripheral PBMC
- Registration Number
- NCT05518409
- Lead Sponsor
- First Affiliated Hospital of Zhejiang University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
-
AD inclusion criteria:
a.Clinical diagnosis of Alzheimer's Disease
-
DLB inclusion criteria:
- Clinical diagnosis of Dementia with Lewy bodies
- Infectious diseases
- autoimmune disease
- heart failure
- chronic obstructive pulmonary disease (COPD)
- cancer
- renal failure
- recently major surgery
- alcohol and / or drug abuse
- disturbance of consciousness
- clinical diagnosis of major depression disorder
- clinical diagnosis of Anxiety disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AD group Detection of cytof in peripheral PBMC 20 subjects who met the diagnostic criteria and exclusion criteria of AD were included in the discovery cohort. AD group Donepezil for patients with AD and DLB 20 subjects who met the diagnostic criteria and exclusion criteria of AD were included in the discovery cohort. DLB group Detection of cytof in peripheral PBMC 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. DLB group Donepezil for patients with AD and DLB 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. Healthy control group Detection of cytof in peripheral PBMC 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.
- Primary Outcome Measures
Name Time Method Immunerepertorie 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 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.
- Secondary Outcome Measures
Name Time Method Mini-mental State Examination（MMSE） 1 year MMSE was used to evaluate the degree of intellectual status and cognitive impairment. Score frame: 0 \~ 30. The lower the score, the more severe the cognitive impairment.
Trial Locations
- Locations (1)
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China