Identifying Parkinson's disease biomarkers in gut nerve cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the relationship between gut nerve cells and Parkinson's disease by examining biomarkers in the microbiome and gut tissue obtained during routine colonoscopy. Participants aged 45 and over will provide samples that may reveal early indicators of Parkinson's disease, potentially leading to earlier diagnosis. The study leverages the accessibility of the enteric nervous system through minimally invasive biopsy, allowing researchers to investigate the connection between gut health and neurological conditions. The findings could enhance our understanding of Parkinson's disease and its onset.

Why it matters

Who can join: the full rules

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

Where it's running

• Weill Cornell Medicine
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Jacqueline Burre, PhD — Weill Medical College of Cornell University
• Study coordinator: Virginia Gao, MD PhD
• Email: vig9070@med.cornell.edu
• Phone: 929-989-7898

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.