NCT05347407 Parkinson's Disease Biomarkers in Nerve Cells in the Gut
| NCT ID | NCT05347407 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Weill Medical College of Cornell University |
| Condition | Parkinson Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2020-12-30 |
| Primary Completion | 2028-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2020-12-30 with a primary completion date of 2028-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Jacqueline Burre, PhD
PRINCIPAL INVESTIGATOR
Weill Medical College of Cornell University
Frequently Asked Questions
Who can join the NCT05347407 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05347407 currently recruiting?
Yes, NCT05347407 is actively recruiting participants. Contact the research team at vig9070@med.cornell.edu for enrollment information.
Where is the NCT05347407 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05347407 clinical trial?
NCT05347407 is sponsored by Weill Medical College of Cornell University. The principal investigator is Jacqueline Burre, PhD at Weill Medical College of Cornell University. The trial plans to enroll 60 participants.
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