Status:
RECRUITING
Parkinson's Disease Biomarkers in Nerve Cells in the Gut
Lead Sponsor:
Weill Medical College of Cornell University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-75 years
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 brai...
Detailed Description
Parkinson's disease affects 1 in 100 people over the age of 65, but the time between disease onset and diagnosis can be many months or years. Interestingly, the pathological hallmarks of Parkinson's d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 30 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05347407
Start Date
December 30 2020
End Date
June 1 2026
Last Update
June 22 2025
Active Locations (1)
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1
Weill Cornell Medicine
New York, New York, United States, 10021