Evaluating a new method for early diagnosis of Parkinson's Disease
Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease:An Observational, Multicenter, Non-Randomized Controlled Study
Guangxi Medical University · NCT06232772
This study is testing a new, less invasive method to see if it can help doctors diagnose Parkinson's Disease earlier using samples from body fluids and skin instead of brain biopsies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Guangxi Medical University (other) |
| Locations | 1 site (Nanning, Guangxi) |
| Trial ID | NCT06232772 on ClinicalTrials.gov |
What this trial studies
This observational, multicenter, non-randomized controlled study aims to assess the effectiveness of the α-Synuclein Ultrafine Fluorescence Detection Method in identifying biomarkers for Parkinson's Disease through various body fluids and skin samples. The study seeks to provide a less invasive alternative to traditional brain biopsies, which are often difficult to perform. By focusing on early diagnosis, the research intends to reduce misdiagnosis rates and improve patient outcomes while minimizing healthcare costs. The study includes patients with clinically defined or probable Parkinson's Disease and aims to enhance diagnostic capabilities in the region.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with clinically defined or probable Parkinson's Disease, regardless of age or gender, who meet specific diagnostic criteria.
Not a fit: Patients with advanced Parkinson's Disease or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of Parkinson's Disease, improving treatment outcomes for patients.
How similar studies have performed: Other studies have explored similar biomarker detection methods, showing promise in improving diagnostic accuracy for neurodegenerative diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanning, Guangxi
- Guangxi Medical University — Nanning, Guangxi, China (RECRUITING)
Study contacts
- Principal investigator: Yousheng Xiao, Professor — Guangxi Medical University
- Study coordinator: Yousheng Xiao, professor
- Email: xys135@126.com
- Phone: +86 15177196935
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson's Disease