Diagnose Parkinsons disease with colonoscopy
- Trial ID
- NCT07204652
- Official Title
- Detection of Phosphorylated Alpha-synuclein Through Routine Colonoscopy to Diagnose Parkinson's Disease and Related Disorders
- Goal
- Diagnose Parkinsons disease with colonoscopy
- 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
The goal is to see whether phosphorylated alpha-synuclein, the abnormal form of the protein linked to Parkinson's, can be detected in routine colon biopsies and help diagnose Parkinson's disease and related disorders. During a routine colonoscopy small tissue samples are taken and tested for phosphorylated alpha-synuclein, the disease-related protein that can accumulate in gut nerve cells, so researchers can learn if gut testing could support diagnosis without changing Parkinson's medications. They are looking for adults 40 to 99 with a confirmed Parkinson's diagnosis by UKPDS Brain Bank Criteria who are already scheduled for routine colonoscopy, excluding people on anticoagulants (single-agent aspirin up to 325 mg or clopidogrel 75 mg may be allowed), or with colon cancer, recent GI illness or surgery, pregnancy, or significant cognitive or decisional impairment.
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. The goal is to see whether phosphorylated alpha-synuclein, the abnormal form of the protein linked to Parkinson's, can be detected in routine colon biopsies and help diagnose Parkinson's disease and related disorders. During a routine colonoscopy small tissue samples are taken and tested for phosphorylated alpha-synuclein, the disease-related protein that can accumulate in gut nerve cells, so researchers can learn if gut testing could support diagnosis without changing Parkinson's medications. They are looking for adults 40 to 99 with a confirmed Parkinson's diagnosis by UKPDS Brain Bank Criteria who are already scheduled for routine colonoscopy, excluding people on anticoagulants (single-agent aspirin up to 325 mg or clopidogrel 75 mg may be allowed), or with colon cancer, recent GI illness or surgery, pregnancy, or significant cognitive or decisional impairment.
- 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 3 years.
- 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.