Immunohistochemical Study of Neurodegenerative Diseases

September 13, 2023 updated by: Hu ShaoHua, First Affiliated Hospital of Zhejiang University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Department of Psychiatry, First Affiliated Hospital of Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AD group
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
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.
Experimental: 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.
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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Immunerepertorie
Time Frame: 1 year
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
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mini-mental State Examination（MMSE）
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
First Affiliated Hospital of Zhejiang University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Li YouMing, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIT20220213B-R1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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