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History of Changes for Study: NCT05347407
Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous (PD-ENS)
Latest version (submitted June 24, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 20, 2022 None (earliest Version on record)
2 June 24, 2022 Contacts/Locations, Study Description, Study Status and Study Identification
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Study NCT05347407
Submitted Date:  April 20, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 19-09020813
Brief Title: Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous (PD-ENS)
Official Title: Biochemical Characterization of Parkinson's Disease-related Proteins in the Enteric Nervous System as a Proxy for Pathological Changes in the Brain
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2022
Overall Status: Recruiting
Study Start: December 30, 2020
Primary Completion: February 6, 2023 [Anticipated]
Study Completion: February 23, 2023 [Anticipated]
First Submitted: April 20, 2022
First Submitted that
Met QC Criteria:
April 20, 2022
First Posted: April 26, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
April 20, 2022
Last Update Posted: April 26, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Weill Medical College of Cornell University
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: The time between Parkinson's disease onset and diagnosis can be many months or years. Interestingly, pathological hallmarks of Parkinson's in the brain can also be seen in the neurons in the gut. It is now believed that Parkinson's disease may begin in the gut, at least in some people. Unlike the neurons in the brain, the neurons in the gut are accessible through routine colonoscopy, and so can be obtained by biopsy to study in the laboratory. In addition, there are links between gut microbes, including bacteria, and the diagnosis of Parkinson's disease. This research study is therefore being done to discover whether the pathology and types of bacteria in the gut can serve as an indicator of Parkinson's disease.
Detailed Description: Parkinson's disease affects 1 in 100 people over the age of 65, but the time between Parkinson's disease onset and diagnosis can be many months or years. Interestingly, pathological hallmarks of Parkinson's in the brain can also be seen in the neurons in the gut and symptoms like constipation often precede the onset of tremor and incoordination by many years. It is now believed that Parkinson's disease may begin in the gut, at least in some people. Unlike the neurons in the brain, the neurons in the gut are accessible through routine colonoscopy, and so can be obtained by biopsy to study in the laboratory. In addition, there are links between gut microbes, including bacteria, and the diagnosis of Parkinson's disease. This research study is therefore being done to discover whether the pathology and types of bacteria in the gut can serve as an indicator of Parkinson's disease in subjects aged 45-75 that could eventually help in earlier diagnosis. It will also strengthen the investigators understanding of the link between the gut and brain in Parkinson's disease.
Open or close this module Conditions
Conditions: Parkinson Disease
Keywords: microbiome
Parkinson's
RBD
Alpha Synuclein
enteric nervous system
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention: Samples Without DNA
Biospecimen 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.
Enrollment: 60 [Anticipated]
Number of Groups/Cohorts 5
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: Subjects with several stages of Parkinson's disease (PD), aged 45 to 75 years old and healthy age-matched control subjects
Sampling Method: Probability Sample
Minimum Age: 45 Years
Maximum Age: 75 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
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
Open or close this module Contacts/Locations
Central Contact Person: Virginia Gao, MD PhD
Telephone: 3476103475
Email: vig9070@nyp.org
Central Contact Backup: Jacqueline Burre, PhD
Telephone: 6469626155
Email: jab2058@med.cornell.edu
Study Officials: Jacqueline Burre, PhD
Principal Investigator
Weill Medical College of Cornell University
Andrea Lee, MD
Principal Investigator
Weill Medical College of Cornell University
Locations: United States, New York
Weill Cornell Medicine
[Recruiting]
New York, New York, United States, 10021
Contact:Contact: Virginia Gao, MD 347-610-3475 vig9070@nyp.org
Contact:Contact: Jacqueline Burre, PhD 6469626155 jab2058@med.cornell.edu
Contact:Principal Investigator: Andrea Lee, M.D.
Contact:Principal Investigator: Jacqueline Burre
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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