Immunohistochemical Study of Neurodegenerative Diseases

Alzheimer Disease Clinical Trial

Official title:

Immunohistochemical Study of Peripheral Blood Mononuclear Cells in Sporadic Alzheimer's Disease and Dementia With Lewy Body

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518409
• Other study ID #: IIT20220213B-R1
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Hu ShaoHua
• Phone: 086-13957162903
• Email: dorhushaohua[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 30, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 100 Years

Eligibility

Inclusion Criteria:

1. AD inclusion criteria:

a.Clinical diagnosis of Alzheimer's Disease

2. DLB inclusion criteria:

1. Clinical diagnosis of Dementia with Lewy bodies

Exclusion Criteria:

1. Infectious diseases

2. autoimmune disease

3. heart failure

4. chronic obstructive pulmonary disease (COPD)

5. cancer

6. renal failure

7. recently major surgery

8. alcohol and / or drug abuse

9. disturbance of consciousness

10. clinical diagnosis of major depression disorder

11. clinical diagnosis of Anxiety disorder

Related Conditions & MeSH terms

• Alzheimer Disease
• Lewy Body Disease
• Neurodegenerative Diseases

Intervention

Biological:
• Detection of cytof in peripheral PBMC
Each subject needs to take 5ml of peripheral venous blood to extract PBMC cells, and then conduct cytof detection. This is a mass spectrometry flow cytometry method based on single cell level. It has the ability to analyze all immune cells with high resolution.

Drug:
• Donepezil for patients with AD and DLB
The subjects in AD and DLB groups were given donepezil at an initial dose of 5mg and then increased to 10mg one month later. Lasting for 1 year.

Locations

Country	Name	City	State
China	Department of Psychiatry, First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunerepertorie	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.	1 year
Primary	immunological Elastic-Net (iEN) model	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.	1 year
Secondary	Mini-mental State Examination(MMSE)	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.	1 year