Predict Parkinson in essential tremor
- Trial ID
- NCT07428447
- Official Title
- Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
- Goal
- Predict Parkinson in essential tremor
- Status
- RECRUITING
- Sponsor
- CND Life Sciences
- Study Type
- OBSERVATIONAL
- Enrollment
- 300 participants
- Conditions
- Essential Tremor, Movement Disorders, Essential Tremor, Essential Tremor-plus
Summary For Families
The goal is to see whether phosphorylated alpha-synuclein, a Parkinson's-related protein, shows up in the skin of people with essential tremor or ET-plus and can predict who is more likely to go on to develop Parkinson's disease. The approach is a biomarker test using small skin biopsies to look for phosphorylated alpha-synuclein, which reflects the abnormal protein clumps seen in Parkinson's; this is not a treatment and it does not affect or interact with levodopa. The study is looking for adults 50 to 85 years old with ET or ET-plus by the 2018 MDS criteria who can consent and complete procedures, and it excludes people with other neurodegenerative disorders, abnormal DaTscan, active bleeding or wound-healing risks, current use of carbidopa-levodopa, or anticoagulant/dual antiplatelet therapy.
Locations
- CND Clinical Research Center, Scottsdale, Arizona, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to see whether phosphorylated alpha-synuclein, a Parkinson's-related protein, shows up in the skin of people with essential tremor or ET-plus and can predict who is more likely to go on to develop Parkinson's disease. The approach is a biomarker test using small skin biopsies to look for phosphorylated alpha-synuclein, which reflects the abnormal protein clumps seen in Parkinson's; this is not a treatment and it does not affect or interact with levodopa. The study is looking for adults 50 to 85 years old with ET or ET-plus by the 2018 MDS criteria who can consent and complete procedures, and it excludes people with other neurodegenerative disorders, abnormal DaTscan, active bleeding or wound-healing risks, current use of carbidopa-levodopa, or anticoagulant/dual antiplatelet therapy.
- Who can participate?
- Participants must be between 50 Years and 85 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 11 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.