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

NCT05347407

RecruitingN/A

Sponsor: Weill Medical College of Cornell University

Conditions: Parkinson Disease

Interventions: Colonoscopy

Countries: United States

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 overview

Sex: ALL

Age: 45 Years to 75 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (1)
  • New York, New York, United States