Alpha synuclein detects early Parkinson
- Trial ID
- NCT06232772
- Official Title
- Research on Novel Biomarkers for Early Diagnosis of Parkinson's Disease:An Observational, Multicenter, Non-Randomized Controlled Study
- Goal
- Alpha synuclein detects early Parkinson
- 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 find early, reliable markers that can diagnose Parkinson's sooner and help tell Parkinson's apart from similar conditions like MSA and PSP so people get the right care faster. Researchers are using an ultrafine fluorescence technique to detect misfolded alpha-synuclein, the protein that clumps in Parkinson's, by making those tiny aggregates light up in biological samples; because it is observational the test does not change treatments or interact with levodopa. About 600 adults aged 18 to 80 will be enrolled, including people with clinically confirmed or probable early-stage PD (Hoehn and Yahr ≤ 2.5), plus comparison groups with MSA and PSP and healthy matched controls. People with secondary Parkinsonism from drugs or vascular causes, severe cognitive impairment, or other major neurodegenerative diseases are not eligible.
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 find early, reliable markers that can diagnose Parkinson's sooner and help tell Parkinson's apart from similar conditions like MSA and PSP so people get the right care faster. Researchers are using an ultrafine fluorescence technique to detect misfolded alpha-synuclein, the protein that clumps in Parkinson's, by making those tiny aggregates light up in biological samples; because it is observational the test does not change treatments or interact with levodopa. About 600 adults aged 18 to 80 will be enrolled, including people with clinically confirmed or probable early-stage PD (Hoehn and Yahr ≤ 2.5), plus comparison groups with MSA and PSP and healthy matched controls. People with secondary Parkinsonism from drugs or vascular causes, severe cognitive impairment, or other major neurodegenerative diseases are not eligible.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 2 years and 2 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- 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.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- 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.