RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 45-75 years old - Parkinson's Disease defined by the modified UK Parkinson's Disease Society Brain Bank criteria, at risk for the development of Parkinson's disease including REM sleep behavior disorder and/or at least one first degree relative with PD or related disorder, and diseases related to Parkinson's disease including the synucleinopathies Lewy Body Dementia and Multiple System Atrophy. - Baseline Hoehn \& Yahr score 1-4 - No contraindications to undergoing screening colonoscopy - Able to give willing to sign a consent form for study participation Who Should NOT Join This Trial: - Clinical features suggestive of a neurodegenerative diagnosis other than synucleinopathy. - Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease, Progressive Supranuclear Palsy (PSP), and Corticobasal syndrome. - Significant concomitant medical disease limiting life expectancy to less than 24 months from study inclusion, or significant and serious concomitant medical disease that is poorly controlled - Signs of active malignant disease or other clinically relevant abnormality on chest x-ray - Active or untreated gastrointestinal disease - Inability to temporarily stop anti-platelet agents or other anti-coagulants without significant risk - Known substance abuse (recent history of abuse of alcohol or other drugs such as barbiturates, cannabinoids and amphetamines) within last 5 years - Contraindication to colonoscopy or associated anesthesia - Pregnancy - In the opinion of the investigator, any other condition regarded as making subject unsuitable for the study Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age 45-75 years old * Parkinson's Disease defined by the modified UK Parkinson's Disease Society Brain Bank criteria, at risk for the development of Parkinson's disease including REM sleep behavior disorder and/or at least one first degree relative with PD or related disorder, and diseases related to Parkinson's disease including the synucleinopathies Lewy Body Dementia and Multiple System Atrophy. * Baseline Hoehn \& Yahr score 1-4 * No contraindications to undergoing screening colonoscopy * Able to give informed consent for study participation Exclusion Criteria: * Clinical features suggestive of a neurodegenerative diagnosis other than synucleinopathy. * Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis or other neurodegenerative diseases such as Alzheimer's disease, Progressive Supranuclear Palsy (PSP), and Corticobasal syndrome. * Significant concomitant medical disease limiting life expectancy to less than 24 months from study inclusion, or significant and serious concomitant medical disease that is poorly controlled * Signs of active malignant disease or other clinically relevant abnormality on chest x-ray * Active or untreated gastrointestinal disease * Inability to temporarily stop anti-platelet agents or other anti-coagulants without significant risk * Known substance abuse (recent history of abuse of alcohol or other drugs such as barbiturates, cannabinoids and amphetamines) within last 5 years * Contraindication to colonoscopy or associated anesthesia * Pregnancy * In the opinion of the investigator, any other condition regarded as making subject unsuitable for the study

Treatments Being Tested

PROCEDURE

Colonoscopy

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.

Locations (1)

Weill Cornell Medicine

New York, New York, United States