Parkinson's Disease Biomarkers in Nerve Cells in the Gut
Recruiting · NCT05347407 · Observational (researchers observe without assigning treatment) · Lead sponsor: Weill Medical College of Cornell University
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Weill Cornell Medicine - New York, New York, United States