Immunohistochemical Study of Neurodegenerative Diseases

NCT05518409 | Unknown

• 1 other identifier: IIT20220213B-R1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Lewy Body Disease; Neurodegenerative Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Mini-mental State Examination（MMSE）

  1 year

Study Arms (3)

AD group

EXPERIMENTAL

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

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

DLB group

EXPERIMENTAL

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.

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

Healthy control group

EXPERIMENTAL

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.

Biological: Detection of cytof in peripheral PBMC

Interventions

Detection of cytof in peripheral PBMC BIOLOGICAL

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.

AD group; DLB group; Healthy control group

Donepezil for patients with AD and DLB DRUG

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.

AD group; DLB group

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a.Clinical diagnosis of Alzheimer's Disease
• Clinical diagnosis of Dementia with Lewy bodies

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Neurodegenerative Diseases

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Li YouMing

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Hu ShaoHua

CONTACT

086-13957162903; dorhushaohua@zju.edu.cn

Qiu CongLong

CONTACT

086-15258339029; qcl198731@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Study Record Dates

• First Submitted: August 9, 2022
• First Posted: August 26, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 30, 2023
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

CN (1)