Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
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 : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date April 20, 2022
First Posted Date April 26, 2022
Last Update Posted Date March 24, 2023
Actual Study Start Date December 30, 2020
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2022)		 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 20, 2022)		 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Parkinson's Disease Biomarkers in Nerve Cells in the Gut
Official Title Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
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.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
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.
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
Condition Parkinson Disease
Intervention 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.
Study Groups/Cohorts
  • Control
    Healthy Patients
    Intervention: Procedure: Colonoscopy
  • Parkinson's Disease
    Patients diagnosed with Parkinson's disease
    Intervention: Procedure: Colonoscopy
  • At risk for PD
    Defined as REM sleep behavior disorder, known genetic risk factor, and/or first degree relatives with PD
    Intervention: Procedure: Colonoscopy
  • Dementia with Lewy Bodies
    Patients diagnosed with Dementia with Lewy Body Disease
    Intervention: Procedure: Colonoscopy
  • Multiple System Atrophy
    Patients diagnosed with Multiple System Atrophy
    Intervention: Procedure: Colonoscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 20, 2022)		 60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2023
Estimated Primary Completion Date November 1, 2023   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Virginia Gao, MD PhD 3476103475 vig9070@med.cornell.edu
Contact: Jacqueline Burre, PhD 6469626155 jab2058@med.cornell.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05347407
Other Study ID Numbers 19-09020813
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Weill Medical College of Cornell University
Original Responsible Party Same as current
Current Study Sponsor Weill Medical College of Cornell University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Jacqueline Burre, PhD Weill Medical College of Cornell University
Principal Investigator: Virginia M Gao, MD PhD Weill Medical College of Cornell University
PRS Account Weill Medical College of Cornell University
Verification Date March 2023