No Intervention: Observational Coh… for Parkinson's (NCT07204652)
Detect Parkinson disease from colon
- Trial ID
- NCT07204652
- Official Title
- Detection of Phosphorylated Alpha-synuclein Through Routine Colonoscopy to Diagnose Parkinson's Disease and Related Disorders
- Goal
- Detect Parkinson disease from colon
- Status
- RECRUITING
- Sponsor
- CND Life Sciences
- Study Type
- OBSERVATIONAL
- Enrollment
- 20 participants
- Conditions
- PARKINSON DISEASE (Disorder), Parkinson, Parkinson's Disease and Parkinsonism, Parkinson Disease
- Interventions
- No Intervention: Observational Cohort
Summary For Families
They want to know whether a protein called alpha-synuclein, which builds up in people with Parkinson's, can be found in small pieces of colon tissue so the disease could be detected earlier than waiting for movement symptoms. During your planned colonoscopy doctors will take four extra tiny tissue samples, two from each side of the colon, which adds about two minutes; before the procedure you will fill out questionnaires, do a brief smell test, and collect one stool sample at home, and the tissue will be tested for the protein though participants will not get individual results. The study is looking for adults 40 to 99 years old who already have a confirmed Parkinson's diagnosis and are already scheduled for a routine colonoscopy; people with recent gut illness or surgery, a history of colon cancer, certain blood thinner use, pregnancy, or significant cognitive impairment are not eligible.
Locations
- Oregon Health & Science University, Portland, Oregon, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying No Intervention: Observational Cohort. They want to know whether a protein called alpha-synuclein, which builds up in people with Parkinson's, can be found in small pieces of colon tissue so the disease could be detected earlier than waiting for movement symptoms. During your planned colonoscopy doctors will take four extra tiny tissue samples, two from each side of the colon, which adds about two minutes; before the procedure you will fill out questionnaires, do a brief smell test, and collect one stool sample at home, and the tissue will be tested for the protein though participants will not get individual results. The study is looking for adults 40 to 99 years old who already have a confirmed Parkinson's diagnosis and are already scheduled for a routine colonoscopy; people with recent gut illness or surgery, a history of colon cancer, certain blood thinner use, pregnancy, or significant cognitive impairment are not eligible.
- 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 3 years.
- 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.
- How many visits does this trial involve?
- One screening visit before the colonoscopy (about 1-2 hours) and the colonoscopy procedure (same length as normally planned).
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Endoscopy (invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.