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
Summary For Families
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.
- 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.