Immunohistochemical Study of Neurodegenerative Diseases

NCT ID: NCT05518409

Last Updated: 2023-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease Lewy Body Disease Neurodegenerative Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AD group

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

Group Type EXPERIMENTAL

Detection of cytof in peripheral PBMC

Intervention Type 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.

Donepezil for patients with AD and DLB

Intervention Type 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.

DLB group

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.

Group Type EXPERIMENTAL

Detection of cytof in peripheral PBMC

Intervention Type 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.

Donepezil for patients with AD and DLB

Intervention Type 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.

Healthy control group

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.

Group Type EXPERIMENTAL

Detection of cytof in peripheral PBMC

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

a.Clinical diagnosis of Alzheimer's Disease

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
Minimum Eligible Age

55 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hu ShaoHua

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Li YouMing

Role: STUDY_CHAIR

Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hu ShaoHua

Role: CONTACT

086-13957162903

Qiu CongLong

Role: CONTACT

086-15258339029

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hu ShaoHua

Role: primary

13957162903

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIT20220213B-R1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy Biomarkers of DAOIB for Dementia
NCT05582161 RECRUITING PHASE2