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NCT06232772Recruiting

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

Source: ClinicalTrials.gov · Last updated 16 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
600 (estimated)
First submitted
20 Jan 2024
Start date
31 Mar 2024
Primary completion date
Jun 2026
Lead sponsor
Yousheng Xiao
NCT number
NCT06232772

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 31 Mar 2024 to the primary completion date, Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Secondary Parkinson's syndrome caused by vascular factors, drugs, etc
  • Severe cognitive impairment, AD, amyotrophic lateral sclerosis and other neurodegenerative diseases

Other

  • Patients who do not consent to study participation

Who the study is looking for

  • 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.

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Guangxi Medical University
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NanningChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.