Parkinson's DiseaseNCT06232772
Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease:An Observational, Multicenter, Non-Randomized Controlled Study
An observational study of Parkinson's Disease, run by Yousheng Xiao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- α- Synuclein Ultrafine Fluorescence Detection Method
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2024to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangxi Medical University
Nanning, Guangxi, 530000
Yousheng Xiao, professor, +86 15177196935, xys135@126.com
Yanzi Bao, postgraduate, +86 17673172378, deer0522@163.com
About this study
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.
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- α- Synuclein Ultrafine Fluorescence Detection Method
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
α- Synuclein Ultrafine Fluorescence Detection MethodDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start31 Mar 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yousheng Xiao
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, Guilin Medical College, Guangxi International Zhuang Medical Hospital
- Responsible party
- Sponsor-investigator, Yousheng Xiao, Guangxi Medical University
- Investigators
- Yousheng Xiao, Professor, Principal investigator, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232772
- Sponsor's protocol ID
- YXiao
- Status last verified
- Apr 2025
- First submitted
- 20 Jan 2024
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease:An Observational, Multicenter, Non-Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06232772
- Acronym / sponsor ID
- YXiao
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Yousheng XiaoUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital, Sun Yat-Sen University, First Affiliated Hospital of Guangxi Medical University, Guilin Medical College, Guangxi International Zhuang Medical Hospital
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| patients with clinically defined PD | – | Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection MethodUsing 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. |
| patients with clinically probable PD | – | Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection MethodUsing 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. |
| MSA group | – | Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection MethodUsing 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. |
| PSP group | – | Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection MethodUsing 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. |
| healthy subjects of equal age and sex without any risk or prodromal factor for PD | – | Diagnostic Test: α- Synuclein Ultrafine Fluorescence Detection Methodcontrol 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| α- Synuclein Ultrafine Fluorescence Detection MethodThis 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. | Diagnostic test | 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 |
Primary outcome
Primary Outcome 1（Accuracy and precision）
Time frame: 3 years
To define test accuracy and precision of skin biopsy and body fluid detection of α-Synuclein Ultra Fine Fluorescence Method.
Primary Outcome 2（Sensitivity and specificity）
Time frame: 3 years
To define sensitivity and specificity of skin biopsy and body fluid detection of α-Synuclein Ultra Fine Fluorescence Method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yousheng Xiao, Professor principal investigator
Guangxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Yousheng Xiao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yousheng Xiao, professor (+86 15177196935, xys135@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1（Accuracy and precision） (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.