We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Parkinson's Disease Biomarkers in Nerve Cells in the Gut (PD-ENS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05347407
Recruitment Status : Recruiting
First Posted : April 26, 2022
Last Update Posted : June 29, 2022
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment
Parkinson Disease Procedure: Colonoscopy

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 disease and other synucleinopathies in the brain can also be seen in the nerve cells in the gut. Parkinson's disease may begin in the gut, at least in some people. Unlike the nerve cells in the brain, the nerve cells in the gut are accessible through routine colonoscopy, and so can be obtained by minimally invasive biopsy for the study in the laboratory. In addition, there are links between gut microbes, including bacteria, and the development of Parkinson's disease.

This research study is being done to discover whether the pathology in enteric nerve cells and the types of bacteria in the gut can serve as an indicator of Parkinson's disease. The goal of this research is to develop a biomarker that could help in earlier diagnosis. It also aims to improve the understanding of the link between the gut and brain in Parkinson's disease.

The American Cancer Society recommends screening colonoscopy starting from the age of 45 for the prevention of colon cancer. The study requires only one visit, and study samples will be collected as part of a colonoscopy needed for routine care.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
Actual Study Start Date : December 30, 2020
Estimated Primary Completion Date : February 6, 2023
Estimated Study Completion Date : February 23, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control
Healthy Patients
Procedure: Colonoscopy
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.

Parkinson's Disease
Patients diagnosed with Parkinson's disease
Procedure: Colonoscopy
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.

At risk for PD
Defined as REM sleep behavior disorder, known genetic risk factor, and/or first degree relatives with PD
Procedure: Colonoscopy
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.

Dementia with Lewy Bodies
Patients diagnosed with Dementia with Lewy Body Disease
Procedure: Colonoscopy
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.

Multiple System Atrophy
Patients diagnosed with Multiple System Atrophy
Procedure: Colonoscopy
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.




Primary Outcome Measures :
  1. Biochemical changes in enteric nervous system [ Time Frame: A single timepoint will be evaluated on biopsy samples taken from subjects during routine screening colonoscopy. ]
    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.


Other Outcome Measures:
  1. Exploratory Objective [ Time Frame: 12 months ]
    Exploratory objectives of the study are to examine whether changes in alpha-synuclein and other biomarkers of Parkinson's disease correlate with age and disease progression. We are interested in whether pathology in the gut precedes or mimics the pathology in the brain, and which areas of the gut are most affected by this pathology. We are also interested in whether we can detect pathological changes in alpha-synuclein and other PD biomarkers, including changes in microbiome, at an early disease stage in humans


Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects with several stages of Parkinson's disease (PD), aged 45 to 75 years old and healthy age-matched control subjects
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05347407


Contacts
Layout table for location contacts
Contact: Virginia Gao, MD PhD 3476103475 vig9070@med.cornell.edu
Contact: Jacqueline Burre, PhD 6469626155 jab2058@med.cornell.edu

Locations
Layout table for location information
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10021
Contact: Virginia Gao, MD PhD    347-610-3475    vig9070@med.cornell.edu   
Contact: Jacqueline Burre, PhD    6469626155    jab2058@med.cornell.edu   
Principal Investigator: Virginia Gao, M.D. PhD         
Principal Investigator: Jacqueline Burre, PhD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Layout table for investigator information
Principal Investigator: Jacqueline Burre, PhD Weill Medical College of Cornell University
Principal Investigator: Virginia M Gao, MD PhD Weill Medical College of Cornell University
Layout table for additonal information
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT05347407    
Other Study ID Numbers: 19-09020813
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: June 29, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Weill Medical College of Cornell University:
microbiome
Parkinson's
RBD
Alpha Synuclein
enteric nervous system
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases