Parkinson's Trial NCT07428447

Detect Parkinson risk from skin

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
Detect Parkinson risk from skin
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

It aims to find which people with essential tremor have early Parkinson's-related protein in their skin and to predict who is most likely to develop Parkinson's disease. The team uses the Syn-One Test, a minimally invasive skin biopsy that looks for phosphorylated alpha-synuclein, a protein tied to Lewy body changes and Parkinson's, to flag higher-risk individuals. Adults 50 to 85 with a diagnosis of essential tremor or ET-plus who can give consent and complete study procedures can join, while people on levodopa, with an abnormal DaTscan (a type of brain imaging), active serious vascular disease, bleeding-risk medications, or other neurologic disorders are excluded.

Locations

  • CND Clinical Research Center, Scottsdale, Arizona, United States
  • Veracity Neurosciences LLC, Memphis, Tennessee, United States

Frequently Asked Questions

What is this trial testing?
This trial is studying an experimental treatment. It aims to find which people with essential tremor have early Parkinson's-related protein in their skin and to predict who is most likely to develop Parkinson's disease. The team uses the Syn-One Test, a minimally invasive skin biopsy that looks for phosphorylated alpha-synuclein, a protein tied to Lewy body changes and Parkinson's, to flag higher-risk individuals. Adults 50 to 85 with a diagnosis of essential tremor or ET-plus who can give consent and complete study procedures can join, while people on levodopa, with an abnormal DaTscan (a type of brain imaging), active serious vascular disease, bleeding-risk medications, or other neurologic disorders are excluded.
Who can participate?
Participants must be between 50 Years and 85 Years.
Where is this trial located?
This trial is recruiting at 2 locations.
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 11 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: Biopsy (invasive); PET scan (minimally invasive). Confirm the full schedule with the study coordinator.

Related Reading

View on ClinicalTrials.gov