Parkinson's Disease Biomarkers in Nerve Cells in the Gut
PD-ENS
Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
2 other identifiers
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 30, 2020
CompletedFirst Submitted
Initial submission to the registry
April 20, 2022
CompletedFirst Posted
Study publicly available on registry
April 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJune 22, 2025
June 1, 2025
5.3 years
April 20, 2022
June 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemical changes in enteric nervous system
The primary objective of the study is to assess the abundance and subcellular distribution of alpha-synuclein and other Parkinson's disease-related proteins in the enteric nervous system of PD patients and healthy controls.
A single timepoint will be evaluated on biopsy samples taken from subjects during routine screening colonoscopy.
Other Outcomes (1)
Exploratory Objective
12 months
Study Arms (5)
Control
Healthy Patients
Parkinson's Disease
Patients diagnosed with Parkinson's disease
At risk for PD
Defined as REM sleep behavior disorder, known genetic risk factor, and/or first degree relatives with PD
Dementia with Lewy Bodies
Patients diagnosed with Dementia with Lewy Body Disease
Multiple System Atrophy
Patients diagnosed with Multiple System Atrophy
Interventions
Patients will be provided with a kit and be asked to bring a stool sample to their colonoscopy appointment. Mucosal biopsies will be collected with standard forceps during colonoscopy. If the physician determines that the patient will need colonoscopy with biopsy as part of their routine clinical care, they will take 6-8 additional biopsies for use in the research study. If the physician determines that the patient will need colonoscopy without biopsy as part of their routine clinical care, they will take 6-8 biopsies for use in the research study only. The collection of additional biopsies will add an estimated two minutes to the whole procedure.
Eligibility Criteria
Subjects with several stages of Parkinson's disease (PD), aged 45 to 75 years old and healthy age-matched control subjects
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Weill Cornell Medicine
New York, New York, 10021, United States
Biospecimen
Patients will be provided with a kit and be asked to bring a stool sample to their colonoscopy appointment. Mucosal biopsies will be collected with standard forceps during colonoscopy.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacqueline Burre, PhD
Weill Medical College of Cornell University
- PRINCIPAL INVESTIGATOR
Virginia M Gao, MD PhD
Weill Medical College of Cornell University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2022
First Posted
April 26, 2022
Study Start
December 30, 2020
Primary Completion
May 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
June 22, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share