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Immunohistochemical Study of Neurodegenerative Diseases

Primary Purpose

Alzheimer Disease, Lewy Body Disease, Neurodegenerative Diseases

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Detection of cytof in peripheral PBMC
Donepezil for patients with AD and DLB
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

55 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Department of Psychiatry, First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AD group

DLB group

Healthy control group

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 9, 2022
Last Updated
September 13, 2023
Sponsor
First Affiliated Hospital of Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05518409
Brief Title
Immunohistochemical Study of Neurodegenerative Diseases
Official Title
Immunohistochemical Study of Peripheral Blood Mononuclear Cells in Sporadic Alzheimer's Disease and Dementia With Lewy Body
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Lewy Body Disease, Neurodegenerative Diseases

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AD group
Arm Type
Experimental
Arm Description
20 subjects who met the diagnostic criteria and exclusion criteria of AD were included in the discovery cohort.
Arm Title
DLB group
Arm Type
Experimental
Arm 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.
Arm Title
Healthy control group
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Detection of cytof in peripheral PBMC
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Donepezil for patients with AD and DLB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Immunerepertorie
Description
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.
Time Frame
1 year
Title
immunological Elastic-Net (iEN) model
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Mini-mental State Examination（MMSE）
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: AD inclusion criteria: a.Clinical diagnosis of Alzheimer's Disease DLB inclusion criteria: Clinical diagnosis of Dementia with Lewy bodies Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hu ShaoHua
Phone
086-13957162903
Email
dorhushaohua@zju.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Qiu CongLong
Phone
086-15258339029
Email
qcl198731@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li YouMing
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hu ShaoHua
Phone
13957162903
Email
dorhushaohua@zju.edu.cn

12. IPD Sharing Statement

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Immunohistochemical Study of Neurodegenerative Diseases

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