Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease:An Observational, Multicenter, Non-Randomized Controlled Study

NCT06232772 | Recruiting

• 1 other identifier: YXiao
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This observational, multicenter, non-randomized controlled study is to evaluate the detection ability of α-Synuclein Ultrafine Fluorescence Detection Method for body fluids (Such as saliva, urine, cerebrospinal fluid, and blood, etc.) and skin in Parkinson's patients.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (2)

• Primary Outcome 1（Accuracy and precision）

  To define test accuracy and precision of skin biopsy and body fluid detection of α-Synuclein Ultra Fine Fluorescence Method.

  3 years

• Primary Outcome 2（Sensitivity and specificity）

  To define sensitivity and specificity of skin biopsy and body fluid detection of α-Synuclein Ultra Fine Fluorescence Method.

  3 years

Study Arms (5)

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.

Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection Method

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.

Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection Method

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.

Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection Method

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.

Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection Method

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.

Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection Method

Interventions

α- Synuclein Ultrafine Fluorescence Detection Method DIAGNOSTIC_TEST

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; PSP group; healthy subjects of equal age and sex without any risk or prodromal factor for PD; patients with clinically defined PD; patients with clinically probable PD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1\) patients with clinically defined PD; 2) patients with clinically probable PD; 3) MSA group; 4) PSP group; 5) healthy subjects of equal age and sex without any risk or prodromal factor for PD.

You may not qualify if:

• MSA group：Adult onset (\>30 years old), sporadic and progressive development, and possessing the following characteristics: 1 Has one of the following two conditions: ① Parkinson's syndrome with levodopa adverse response (bradykinesia, accompanied by muscle rigidity, tremors, or postural instability), ② cerebellar dysfunction: gait ataxia, accompanied by cerebellar articulation disorders, limb ataxia, or cerebellar eye movement disorders; 2. At least one manifestation of autonomic dysfunction is present: ① urinary incontinence (inability to control bladder urination, male with erectile dysfunction), ② orthostatic hypotension (a decrease in systolic blood pressure of ≥ 30mmHg and/or diastolic blood pressure of ≥ 15mmHg after standing for 3 minutes).
• 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

Sponsors & Collaborators

• Yousheng Xiao: lead
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine: collaborator
• Guilin Medical College: collaborator
• Guangxi International Zhuang Medical Hospital: collaborator

Study Sites (1)

Guangxi Medical University

Nanning, Guangxi, 530000, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yousheng Xiao, Professor

  Guangxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yousheng Xiao, professor

CONTACT

+86 15177196935; xys135@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 20, 2024
• First Posted: January 31, 2024
• Study Start: March 31, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (1)