α- Synuclein Ultrafine Fluorescenc… for Parkinson's (NCT06232772)
Diagnose Parkinson earlier using skin
- Trial ID
- NCT06232772
- Official Title
- Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease:An Observational, Multicenter, Non-Randomized Controlled Study
- Goal
- Diagnose Parkinson earlier using skin
- Status
- RECRUITING
- Sponsor
- Yousheng Xiao
- Study Type
- OBSERVATIONAL
- Enrollment
- 600 participants
- Conditions
- Parkinson's Disease
- Interventions
- α- Synuclein Ultrafine Fluorescence Detection Method
Summary For Families
The goal is to see if a lab test can find abnormal clumps of a protein called alpha-synuclein in saliva, urine, spinal fluid, blood, and a tiny skin sample, so Parkinson's and related conditions can be diagnosed earlier and more accurately without needing a brain biopsy. The study uses an ultrafine fluorescence detection method on those body fluids and a 1 mm skin sample, a low-harm procedure, to evaluate how well the test reflects the amount of abnormal protein and helps tell similar diseases apart. This approach could cut down repeat testing and help with early intervention and better regional diagnosis. They are enrolling adults 18 to 80, including people with confirmed or probable Parkinson's at earlier stages (up to about 2.5 on the common Parkinson's staging scale), people with disorders like multiple system atrophy or progressive supranuclear palsy, and healthy age- and sex-matched volunteers; people with secondary Parkinson's from drugs or vascular causes or with severe other neurodegenerative diseases are excluded.
Locations
- Guangxi Medical University, Nanning, Guangxi, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying α- Synuclein Ultrafine Fluorescence Detection Method. The goal is to see if a lab test can find abnormal clumps of a protein called alpha-synuclein in saliva, urine, spinal fluid, blood, and a tiny skin sample, so Parkinson's and related conditions can be diagnosed earlier and more accurately without needing a brain biopsy. The study uses an ultrafine fluorescence detection method on those body fluids and a 1 mm skin sample, a low-harm procedure, to evaluate how well the test reflects the amount of abnormal protein and helps tell similar diseases apart. This approach could cut down repeat testing and help with early intervention and better regional diagnosis. They are enrolling adults 18 to 80, including people with confirmed or probable Parkinson's at earlier stages (up to about 2.5 on the common Parkinson's staging scale), people with disorders like multiple system atrophy or progressive supranuclear palsy, and healthy age- and sex-matched volunteers; people with secondary Parkinson's from drugs or vascular causes or with severe other neurodegenerative diseases are excluded.
- Who can participate?
- Participants must be between 18 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 2 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); Biopsy (invasive). Confirm the full schedule with the study coordinator.