Detect Parkinson using gut biopsy
- 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
- Detect Parkinson using gut biopsy
- Status
- RECRUITING
- Sponsor
- Weill Medical College of Cornell University
- Study Type
- OBSERVATIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease
- Interventions
- Colonoscopy
Summary For Families
Goal: to find out whether abnormal Parkinson's-related proteins in the gut, especially misfolded alpha-synuclein, mirror the pathological changes in the brain and could serve as a peripheral marker of disease. Approach: during a colonoscopy researchers take small biopsies of the enteric nervous system and run biochemical tests to detect misfolded alpha-synuclein and related protein changes, the study is observational so no new drug is given. Eligibility: adults 45 to 75 years old with Parkinson's disease or at higher risk (for example REM sleep behavior disorder or a first degree relative), Hoehn and Yahr stage 1 to 4, able to undergo colonoscopy and give informed consent; people with other non-synuclein neurodegenerative diseases, active GI disease, inability to safely stop anticoagulants, pregnancy, recent substance abuse, or serious uncontrolled medical problems are excluded.
Locations
- Weill Cornell Medicine, New York, New York, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Colonoscopy. Goal: to find out whether abnormal Parkinson's-related proteins in the gut, especially misfolded alpha-synuclein, mirror the pathological changes in the brain and could serve as a peripheral marker of disease. Approach: during a colonoscopy researchers take small biopsies of the enteric nervous system and run biochemical tests to detect misfolded alpha-synuclein and related protein changes, the study is observational so no new drug is given. Eligibility: adults 45 to 75 years old with Parkinson's disease or at higher risk (for example REM sleep behavior disorder or a first degree relative), Hoehn and Yahr stage 1 to 4, able to undergo colonoscopy and give informed consent; people with other non-synuclein neurodegenerative diseases, active GI disease, inability to safely stop anticoagulants, pregnancy, recent substance abuse, or serious uncontrolled medical problems are excluded.
- 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?
- 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 7 years and 6 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.