Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease:An Observational, Multicenter, Non-Randomized Controlled Study
NCT ID: NCT06232772
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-03-31
2026-06-30
Brief Summary
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Detailed Description
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Clinical needs: α-Synaptic nucleoprotein lineage diseases (Parkinson's disease, multisystem atrophy, and Lewy body dementia) have complex early symptoms, making diagnosis and differential diagnosis difficult. Early diagnosis is crucial for disease prognosis. Authoritative theories suggest that brain tissue biopsy is necessary for the diagnosis of this group of diseases, but it is difficult to generalize in clinical practice. Therefore, there is a 20% misdiagnosis and missed diagnosis rate in the clinical diagnosis of α-synaptic nuclear protein spectrum diseases. The α-Synuclein Ultrafine Fluorescence Detection Method for body fluids and skin in Parkinson's patients can truly reflect the degree of pathological aggregation in synapses, which is helpful for early diagnosis and evaluation of diseases.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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patients with clinically defined PD
Using an ELISA kit and α- Synuclein Ultrafine Fluorescence Detection Method to analyze the skin and body fluids of the included subjects α- synuclein level detection.
α- Synuclein Ultrafine Fluorescence Detection Method
This technology belongs to the detection of a-syn aggregates in extracranial tissues, which can replace brain biopsy operations that are difficult to carry out clinically, thus breaking through the limitations of clinical experience in diagnosing a-synuclein lineage diseases and greatly improving the diagnostic and differential diagnostic level of this group of diseases.
patients with clinically probable PD
Using an ELISA kit and α- Synuclein Ultrafine Fluorescence Detection Method to analyze the skin and body fluids of the included subjects α- synuclein level detection.
α- Synuclein Ultrafine Fluorescence Detection Method
This technology belongs to the detection of a-syn aggregates in extracranial tissues, which can replace brain biopsy operations that are difficult to carry out clinically, thus breaking through the limitations of clinical experience in diagnosing a-synuclein lineage diseases and greatly improving the diagnostic and differential diagnostic level of this group of diseases.
MSA group
Using an ELISA kit and α- Synuclein Ultrafine Fluorescence Detection Method to analyze the skin and body fluids of the included subjects α- synuclein level detection.
α- Synuclein Ultrafine Fluorescence Detection Method
This technology belongs to the detection of a-syn aggregates in extracranial tissues, which can replace brain biopsy operations that are difficult to carry out clinically, thus breaking through the limitations of clinical experience in diagnosing a-synuclein lineage diseases and greatly improving the diagnostic and differential diagnostic level of this group of diseases.
PSP group
Using an ELISA kit and α- Synuclein Ultrafine Fluorescence Detection Method to analyze the skin and body fluids of the included subjects α- synuclein level detection.
α- Synuclein Ultrafine Fluorescence Detection Method
This technology belongs to the detection of a-syn aggregates in extracranial tissues, which can replace brain biopsy operations that are difficult to carry out clinically, thus breaking through the limitations of clinical experience in diagnosing a-synuclein lineage diseases and greatly improving the diagnostic and differential diagnostic level of this group of diseases.
healthy subjects of equal age and sex without any risk or prodromal factor for PD
control group Using an ELISA kit and α- Synuclein Ultrafine Fluorescence Detection Method to analyze the skin and body fluids of the included subjects α- synuclein level detection.
α- Synuclein Ultrafine Fluorescence Detection Method
This technology belongs to the detection of a-syn aggregates in extracranial tissues, which can replace brain biopsy operations that are difficult to carry out clinically, thus breaking through the limitations of clinical experience in diagnosing a-synuclein lineage diseases and greatly improving the diagnostic and differential diagnostic level of this group of diseases.
Interventions
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α- Synuclein Ultrafine Fluorescence Detection Method
This technology belongs to the detection of a-syn aggregates in extracranial tissues, which can replace brain biopsy operations that are difficult to carry out clinically, thus breaking through the limitations of clinical experience in diagnosing a-synuclein lineage diseases and greatly improving the diagnostic and differential diagnostic level of this group of diseases.
Eligibility Criteria
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Exclusion Criteria
* PSP group：Clinical diagnosis and likely PSP included in the Chinese progressive supranuclear palsy clinical diagnostic criteria developed by the Parkinson's disease and motor disorders group of the Neurology Branch of the Chinese Medical Association in 2016;
* Healthy subjects：Healthy population matched with age and gender in the experimental group In addition to the selected patients, a study will also be conducted on patient data in the reference database of the proposing institution.
* Patients who do not consent to study participation
* Secondary Parkinson's syndrome caused by vascular factors, drugs, etc
* Severe cognitive impairment, AD, amyotrophic lateral sclerosis and other neurodegenerative diseases
18 Years
80 Years
ALL
Yes
Sponsors
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The First Affiliated Hospital of Guangzhou Medical University
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
UNKNOWN
Guilin Medical College
OTHER
Guangxi International Zhuang Medical Hospital
UNKNOWN
Yousheng Xiao
OTHER
Responsible Party
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Yousheng Xiao
professor
Principal Investigators
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Yousheng Xiao, Professor
Role: PRINCIPAL_INVESTIGATOR
Guangxi Medical University
Locations
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Guangxi Medical University
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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YXiao
Identifier Type: -
Identifier Source: org_study_id
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