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

Inclusion Criteria5

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 Criteria10

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

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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.