Parkinson's Trial NCT07217054
Detect Parkinson using colon samples
- Trial ID
- NCT07217054
- Official Title
- Detection of Phosphorylated Alpha-Synuclein in Colonic Tissue Biopsy During Routine Colonoscopy
- Goal
- Detect Parkinson using colon samples
- Status
- RECRUITING
- Sponsor
- CND Life Sciences
- Study Type
- OBSERVATIONAL
- Enrollment
- 40 participants
- Conditions
- PARKINSON DISEASE (Disorder), Parkinson, Parkinson s Disease, Parkinson Disease
Summary For Families
The goal is to find out whether small colon tissue samples taken during a routine colonoscopy can show a protein called alpha-synuclein that builds up in people with Parkinson's disease or REM sleep behavior disorder, so the condition might be detectable earlier than by watching for movement or sleep symptoms. During the planned colonoscopy, doctors will take four extra tiny samples, two from each side of the colon, which adds about two minutes; those samples are tested for the protein, no extra visits are needed, and participants will not receive individual test results. The study is enrolling adults aged 40 to 99 who already have a clinical diagnosis of Parkinson's disease or REM sleep behavior disorder and who are scheduled for a routine colonoscopy; people on most blood thinners or with active gut illness or recent abdominal surgery are not eligible, though low-dose aspirin or Plavix alone may be allowed.
Locations
- Digestive Disease Associates, Branford, Connecticut, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to find out whether small colon tissue samples taken during a routine colonoscopy can show a protein called alpha-synuclein that builds up in people with Parkinson's disease or REM sleep behavior disorder, so the condition might be detectable earlier than by watching for movement or sleep symptoms. During the planned colonoscopy, doctors will take four extra tiny samples, two from each side of the colon, which adds about two minutes; those samples are tested for the protein, no extra visits are needed, and participants will not receive individual test results. The study is enrolling adults aged 40 to 99 who already have a clinical diagnosis of Parkinson's disease or REM sleep behavior disorder and who are scheduled for a routine colonoscopy; people on most blood thinners or with active gut illness or recent abdominal surgery are not eligible, though low-dose aspirin or Plavix alone may be allowed.
- Who can participate?
- Participants must be between 40 Years and 99 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 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: Endoscopy (invasive). Confirm the full schedule with the study coordinator.