RecruitingNCT05347407

Parkinson's Disease Biomarkers in Nerve Cells in the Gut

Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain

Sponsor

Weill Medical College of Cornell University

Enrollment

60 participants

Start Date

Dec 30, 2020

Study Type

OBSERVATIONAL

Conditions

Parkinson Disease

Summary

Parkinson's disease affects all the nerve cells in the body, including the ones in the gut. The gut contains its own nervous system, the enteric nervous system, and can be thought of as a "second brain". This second brain can reflect what is going on in the actual brain. This study is being done to look for biomarkers, or early indicators of developing Parkinson's disease, in the microbiome and in the gut tissue taken during routine screening colonoscopy. People aged 45 and over who are due for their routine screening colonoscopy are eligible to participate.

Eligibility

Min Age: 45 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for biological markers of Parkinson's disease in nerve cells found inside the gut, using samples collected during routine colonoscopy. The goal is to better understand how and why Parkinson's disease develops, and whether early signs can be detected in the digestive system. **You may be eligible if...** - You are between 45 and 75 years old - You have been diagnosed with Parkinson's disease, a related condition (like Lewy Body Dementia or Multiple System Atrophy), or are at risk for Parkinson's (e.g., you have REM sleep behavior disorder or a first-degree relative with the disease) - You have a Hoehn and Yahr stage between 1 and 4 (a scale measuring Parkinson's severity) - You can safely undergo a colonoscopy **You may NOT be eligible if...** - You have a different type of neurological condition (not Parkinson's-related) - You have epilepsy, multiple sclerosis, Alzheimer's disease, or certain other brain conditions - You have active or untreated gastrointestinal disease - You are taking blood thinners that cannot be safely stopped - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREColonoscopy

Patients will be provided with a kit and be asked to bring a stool sample to their colonoscopy appointment. Mucosal biopsies will be collected with standard forceps during colonoscopy. If the physician determines that the patient will need colonoscopy with biopsy as part of their routine clinical care, they will take 6-8 additional biopsies for use in the research study. If the physician determines that the patient will need colonoscopy without biopsy as part of their routine clinical care, they will take 6-8 biopsies for use in the research study only. The collection of additional biopsies will add an estimated two minutes to the whole procedure.