Actively Recruiting

Age: 45Years - 75Years
All Genders
Healthy Volunteers
NCT05347407

Parkinson's Disease Biomarkers in Nerve Cells in the Gut

Led by Weill Medical College of Cornell University · Updated on 2025-06-22

60

Participants Needed

1

Research Sites

282 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Parkinson's Disease Biomarkers in Nerve Cells in the Gut

Who Can Participate

Age: 45Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 45-75 years old
  • Parkinson's Disease defined by modified UK Parkinson's Disease Society Brain Bank criteria, or at risk for Parkinson's including REM sleep behavior disorder or a first-degree relative with Parkinson's or related disorders
  • Related diseases including Lewy Body Dementia and Multiple System Atrophy
  • Baseline Hoehn & Yahr score between 1 and 4
  • No contraindications to routine screening colonoscopy
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Signs of neurodegenerative diseases other than synucleinopathy
  • Diagnosis of primary mitochondrial disorder, epilepsy, stroke, multiple sclerosis, Alzheimer's disease, Progressive Supranuclear Palsy, or Corticobasal syndrome
  • Serious medical conditions limiting life expectancy to less than 24 months or poorly controlled severe diseases
  • Active cancer or abnormal chest x-ray findings
  • Active or untreated gastrointestinal disease
  • Unable to stop anti-platelet or anticoagulant medications safely
  • Known substance abuse within the last 5 years
  • Contraindication to colonoscopy or anesthesia
  • Pregnancy
  • Any other condition that makes participation unsuitable as judged by the investigator

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Weill Cornell Medicine

New York, New York, United States, 10021

Actively Recruiting

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Research Team

V

Virginia Gao, MD PhD

CONTACT

J

Jacqueline Burre, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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Parkinson's Disease Biomarkers in Nerve Cells in the Gut | DecenTrialz