Detect Parkinson protein changes early
- Trial ID
- NCT04724941
- Official Title
- Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study
- Goal
- Detect Parkinson protein changes early
- Status
- RECRUITING
- Sponsor
- University Hospital Schleswig-Holstein
- Study Type
- OBSERVATIONAL
- Enrollment
- 2000 participants
- Conditions
- Parkinson Disease
- Interventions
- No intervention
Summary For Families
The goal is to detect abnormal alpha-synuclein in people before they have clear Parkinson's symptoms, so researchers can identify biological signs of prodromal disease earlier. The approach is observational screening, collecting clinical measures and biological samples to look for alpha-synuclein biomarkers, with a lumbar puncture substudy that analyzes cerebrospinal fluid for misfolded alpha-synuclein, and no experimental treatments are given. The study plans to enroll up to 2000 adults aged 50 to 99 who do not have clinical Parkinson's. People with other significant neurologic or orthopedic conditions that affect motor assessment are excluded, and anyone with contraindications to lumbar puncture or on anticoagulants cannot participate in that substudy.
Locations
- Department for Neurology, University of Kiel, Kiel, Germany
Frequently Asked Questions
- What is this trial testing?
- This trial is studying No intervention. The goal is to detect abnormal alpha-synuclein in people before they have clear Parkinson's symptoms, so researchers can identify biological signs of prodromal disease earlier. The approach is observational screening, collecting clinical measures and biological samples to look for alpha-synuclein biomarkers, with a lumbar puncture substudy that analyzes cerebrospinal fluid for misfolded alpha-synuclein, and no experimental treatments are given. The study plans to enroll up to 2000 adults aged 50 to 99 who do not have clinical Parkinson's. People with other significant neurologic or orthopedic conditions that affect motor assessment are excluded, and anyone with contraindications to lumbar puncture or on anticoagulants cannot participate in that substudy.
- Who can participate?
- Participants must be between 50 Years and 99 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 6 years and 6 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.