Detect colonic phosphorylated alpha synuclein
- Trial ID
- NCT07217054
- Official Title
- Detection of Phosphorylated Alpha-Synuclein in Colonic Tissue Biopsy During Routine Colonoscopy
- Goal
- Detect colonic phosphorylated alpha synuclein
- Status
- RECRUITING
- Sponsor
- CND Life Sciences
- Study Type
- OBSERVATIONAL
- Enrollment
- 40 participants
- Conditions
- PARKINSON DISEASE (Disorder), Parkinson, Parkinson s Disease, Parkinson Disease
Plain-Language Summary
The goal is to see whether a pathological form of alpha-synuclein, called phosphorylated alpha-synuclein, can be detected in colon biopsy tissue and whether that finding could help confirm Parkinson's or flag higher risk in people with REM sleep behavior disorder. The approach is to collect small biopsy samples during a routine colonoscopy and test the tissue for phosphorylated alpha-synuclein, this is an observational biomarker study and it does not change Parkinson's medications like levodopa. If phosphorylated alpha-synuclein is present in colon tissue, it could serve as a supportive tissue biomarker for diagnosis or early detection. The study is enrolling adults 40 to 99 who already agree to have a routine colonoscopy and who have clinically confirmed Parkinson's disease or clinically confirmed RBD without PD, DLB, or MSA; people on anticoagulants, with active GI illness, recent abdominal surgery, active cancer treatment, pregnancy, or significant cognitive impairment are excluded, though 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 see whether a pathological form of alpha-synuclein, called phosphorylated alpha-synuclein, can be detected in colon biopsy tissue and whether that finding could help confirm Parkinson's or flag higher risk in people with REM sleep behavior disorder. The approach is to collect small biopsy samples during a routine colonoscopy and test the tissue for phosphorylated alpha-synuclein, this is an observational biomarker study and it does not change Parkinson's medications like levodopa. If phosphorylated alpha-synuclein is present in colon tissue, it could serve as a supportive tissue biomarker for diagnosis or early detection. The study is enrolling adults 40 to 99 who already agree to have a routine colonoscopy and who have clinically confirmed Parkinson's disease or clinically confirmed RBD without PD, DLB, or MSA; people on anticoagulants, with active GI illness, recent abdominal surgery, active cancer treatment, pregnancy, or significant cognitive impairment are excluded, though 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?
- 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 11 months.