Recruiting · registry statusLooking for early signs of Parkinson’s in body fluids
Researchers test a method for detecting alpha-synuclein, a protein linked to Parkinson’s, in samples such as saliva and urine.
Learning by observing or collecting information · Study reference: NCT06232772
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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Looking for volunteers
- Start (reported actual date)
- 2024-03-31
- Main measurements finished (planned)
- 2026-06
- Study finished (planned)
- 2026-06
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
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Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Ages 18 years to 80 years · Also accepts healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
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
Full study name & original research details
Official study title
Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease:An Observational, Multicenter, Non-Randomized Controlled Study
Original description
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.
Further description from the registry
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 reported: Parkinson's Disease
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Observational
- Interventions
- α- Synuclein Ultrafine Fluorescence Detection Method
- Phases
- Not reported
- Sponsor
- Yousheng Xiao
- Start date reported by registry
- 2024-03-31 (actual)
Registry updated: 2025-04-16 · Status last verified by the registry submitter: 2025-04
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Yousheng Xiao, professor · +86 15177196935 · xys135@126.com
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
Guangxi Medical University
Nanning, Guangxi, China
RecruitingYousheng Xiao, professor · +86 15177196935 · xys135@126.com
Yanzi Bao, postgraduate · +86 17673172378 · deer0522@163.com
Yousheng Xiao, professor
Pingyi Xu, professor
Zhong Pei, professor
Yuyin Hu, assoc. Prof.
Meiling Chen, assoc. Prof.
Li Wang, Ph.D.
Huang Huaxin, postgraduate
Yanzi Bao, postgraduate
The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.