Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease

The goal of this observational 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson's Disease
• Intervention / Treatment: Diagnostic test: α- Synuclein Ultrafine Fluorescence Detection Method

Detailed Description

Social benefits: This technology has minimal harm (skin sampling diameter of 1mm), rather than surgical traumatic brain biopsy, which meets the minimum harm and maximum benefit; 1) Clear clinical diagnosis and differential diagnosis of diseases at once, avoiding repetitive examinations, effectively saving medical expenses and medical insurance funds; 2) Beneficial for early diagnosis and intervention, reducing social and economic burden; 3) Enhance the disease diagnosis and treatment capabilities of the region, enhance basic medical research, and enhance the medical level of the region. Clinical advantage: This technology belongs to extracranial tissues α-Syn aggregate testing can replace brain biopsy procedures 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.

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.

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Yousheng Xiao, professor; Phone Number: +86 15177196935; Email: xys135@126.com

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530000
      • Guangxi Medical University
      • Contact: Yousheng Xiao, professor; Phone Number: +86 15177196935; Email: xys135@126.com
      • Contact: Yanzi Bao, postgraduate; Phone Number: +86 17673172378; Email: deer0522@163.com
      • Principal Investigator: Yousheng Xiao, professor
      • Sub-Investigator: Yanzi Bao, postgraduate
      • Sub-Investigator: Huaxin Huang, postgraduate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• Patients with clinically defined or probable PD：According to the 2015 MDS diagnostic criteria, patients diagnosed with "clinically confirmed PD" regardless of age, gender, and meeting Hoehn&Yahr staging ≤ 2.5 were included as case group one, which met [Parkinson's syndrome+at least two supportive criteria+no absolute exclusion criteria]
• Patients with clinically probable PD：According to the 2015 MDS diagnostic criteria, patients diagnosed with "clinically probable PD", regardless of age or gender, and meeting Hoehn&Yahr staging ≤ 2.5 were included as case group two, i.e. patients who met [Parkinson's syndrome+no absolute exclusion criteria+1/2 supportive criteria+1/2 warning signs]
• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.	Diagnostic test: 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.	Diagnostic test: 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.	Diagnostic test: 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.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Yousheng Xiao
• Investigators: Principal Investigator: Yousheng Xiao, Professor, Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 20, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: YXiao

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No