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Immunohistochemical Study of Neurodegenerative Diseases

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05518409
Enrollment
100
Registered
2022-08-26
Start date
2022-04-01
Completion date
2023-12-30
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Lewy Body Disease, Neurodegenerative Diseases

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.

Interventions

BIOLOGICALDetection 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.

DRUGDonepezil 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.

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Immunerepertorie1 yearThe 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) model1 yearThe 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

MeasureTime frameDescription
Mini-mental State Examination(MMSE)1 yearMMSE 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.

Countries

China

Contacts

Primary ContactHu ShaoHua
dorhushaohua@zju.edu.cn086-13957162903
Backup ContactQiu CongLong
qcl198731@126.com086-15258339029

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026