Immunohistochemical Study of Neurodegenerative Diseases

Zhejiang University

Status: Enrolling

Conditions: Alzheimer Disease; Neurodegenerative Diseases; Lewy Body Disease

Treatments: Drug: Donepezil for patients with AD and DLB; Biological: Detection of cytof in peripheral PBMC

Study type: Interventional

Funder types: Other

Identifiers

NCT05518409

IIT20220213B-R1

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

AD group

Experimental group

Description:

20 subjects who met the diagnostic criteria and exclusion criteria of AD were included in the discovery cohort.

Treatment:

Drug: Donepezil for patients with AD and DLB

Biological: Detection of cytof in peripheral PBMC

DLB group

Experimental group

Description:

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.

Treatment:

Drug: Donepezil for patients with AD and DLB

Biological: Detection of cytof in peripheral PBMC

Healthy control group

Experimental group

Description:

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.

Treatment:

Biological: Detection of cytof in peripheral PBMC