Identifying Parkinson's disease biomarkers in gut nerve cells
Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
This study is trying to see if samples from gut nerve cells can help spot early signs of Parkinson's disease in people aged 45 and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 75 Years |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05347407 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between gut nerve cells and Parkinson's disease by examining biomarkers in the microbiome and gut tissue obtained during routine colonoscopy. Participants aged 45 and over will provide samples that may reveal early indicators of Parkinson's disease, potentially leading to earlier diagnosis. The study leverages the accessibility of the enteric nervous system through minimally invasive biopsy, allowing researchers to investigate the connection between gut health and neurological conditions. The findings could enhance our understanding of Parkinson's disease and its onset.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-75 who are at risk for developing Parkinson's disease or have related disorders.
Not a fit: Patients with other neurodegenerative diseases or significant medical conditions limiting life expectancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis of Parkinson's disease through the identification of gut biomarkers.
How similar studies have performed: While the approach of examining gut biomarkers in relation to Parkinson's disease is innovative, similar studies have shown promise in linking gut health to neurological conditions.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jacqueline Burre, PhD — Weill Medical College of Cornell University
- Study coordinator: Virginia Gao, MD PhD
- Email: vig9070@med.cornell.edu
- Phone: 3476103475
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.