Colonoscopy for Parkinson's (NCT05347407)
Early Parkinsons detection from gut
- Trial ID
- NCT05347407
- Official Title
- Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
- Goal
- Early Parkinsons detection from gut
- Status
- RECRUITING
- Sponsor
- Weill Medical College of Cornell University
- Study Type
- OBSERVATIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease
- Interventions
- Colonoscopy
Summary For Families
The study is looking for early signs of Parkinson's in the gut so a future test could detect the disease sooner and help explain how the gut and brain are linked. During a routine screening colonoscopy, researchers will take small samples of gut tissue and study the gut microbes to see whether the nerve cells and bacteria show the same Parkinson's-related changes seen in the brain. All study samples are collected during that one colonoscopy visit, using a minimally invasive biopsy done as part of routine care. Adults aged 45 to 75 who are scheduled for a screening colonoscopy can join, including people with Parkinson's, people at higher risk such as those who act out their dreams during sleep or who have a first-degree relative with Parkinson's, and people with related disorders like Lewy Body dementia or multiple system atrophy, provided they can safely undergo colonoscopy and give informed consent.
Locations
- Weill Cornell Medicine, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Colonoscopy. The study is looking for early signs of Parkinson's in the gut so a future test could detect the disease sooner and help explain how the gut and brain are linked. During a routine screening colonoscopy, researchers will take small samples of gut tissue and study the gut microbes to see whether the nerve cells and bacteria show the same Parkinson's-related changes seen in the brain. All study samples are collected during that one colonoscopy visit, using a minimally invasive biopsy done as part of routine care. Adults aged 45 to 75 who are scheduled for a screening colonoscopy can join, including people with Parkinson's, people at higher risk such as those who act out their dreams during sleep or who have a first-degree relative with Parkinson's, and people with related disorders like Lewy Body dementia or multiple system atrophy, provided they can safely undergo colonoscopy and give informed consent.
- Who can participate?
- Participants must be between 45 Years and 75 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 7 years and 6 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.
- How many visits does this trial involve?
- The study requires only one in-person visit.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Endoscopy (invasive); Biopsy (invasive). Confirm the full schedule with the study coordinator.