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Exploration of the Enteric Nervous System in Alzheimer Disease (SYNEMA)

Primary Purpose

Alzheimer Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
biopsies of colon
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring Enteric nervous system, Alzheimer disease, biomarker, colonic biopsies, neurodegenerative disease

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • For the 3 groups of patients : colonoscopy planned by a gastroenterologist in the context ot the usual medical follow-up of the patient

For patients with Alzheimer's disease :

  • Patient with early to moderate Alzheimer disease (continuum of patients with mild cognitive impairment due to Alzheimer's disease and patients diagnosed with probable Alzheimer's disease) according to the National Institute of Aging-Alzheimer's Association (NIA AA) criteria
  • Mini-Mental State Examination (MMSE) score ≥18;
  • Has one informant or care partner;
  • No parkinsonian syndrome
  • No sign of lewy Body dementia

For patients with Parkinson's disease:

  • patients with Parkinson Disease according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
  • No dementia sign or cognitive deficit associated to Alzheimer's disease

For patients without neurodegenerative disease:

  • No history or current neurological/degenerative condition (e.g, lewy body dementia, Parkinson's disease, Parkinsonian syndrome, Alzheimer's disease,…)
  • No memory complaint with a Mac Nair score ≤15
  • MMSE score ≥28 ;
  • Patient at risk of colic cancer with a colonoscopy scheduled

Exclusion Criteria:

For the 3 groups of patients : :

  • History of colonic disorder ((e.g inflammatory condition, adenocarcinoma)
  • contra-indications to colonoscopy

For patients with Alzheimer's disease and for patients with Parkinson's disease:

- Any neurological/neurodegenerative condition different from the group to which it belongs (e.g other than Alzheimer's disease for Alzheimer's disease group or other than Parkinson's disease for Parkinson's disease group….)

For patients without neurodegenerative disease:

  • Any neurological/neurodegenerative condition (e.g lewy body dementia, Parkinsonian syndrome, Parkinson's disease, Alzheimer's disease..)..
  • functional colopathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    Patients with Alzheimer's disease

    Patients with Parkinson's disease

    Patients without neurodegenerative disease

    Arm Description

    During the course of the colonoscopy that the patients should have in the context of their usual medical care, additional biopsies of colon will be removed to perform in vitro analysis for this study.

    During the course of the colonoscopy that the patients should have in the context of their usual medical care, additional biopsies of colon will be removed to perform in vitro analysis for this study.

    During the course of the colonoscopy that the patients should have in the context of their usual medical care, additional biopsies of colon will be removed to perform in vitro analysis for this study.

    Outcomes

    Primary Outcome Measures

    Differences in extracellular deposits of beta-amyloid peptide in the enteric nervous system between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease.
    In vitro analysis of the presence of beta-amyloid peptide in biopsies of colon from patients with Alzheimer's disease ans as controls from patients with Parkinson's disease and from patients without neurodegenerative disease

    Secondary Outcome Measures

    Differences in tau protein in the enteric nervous system between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease.
    In vitro analysis of the presence of tau protein in biopsies of colon from patients with Alzheimer's disease ans as controls from patients with Parkinson's disease and from patients without neurodegenerative disease
    Differences in neuronal loss in enteric submucosal tissue between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease
    In vitro analysis of the presence of neuronal loss in biopsies of colon from patients with Alzheimer's disease ans as controls from patients with Parkinson's disease and from patients without neurodegenerative disease
    Differences in neuronal Glia cells in the enteric nervous system between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease.
    In vitro analysis of the presence neuronal glia cells in biopsies of colon from patients with Alzheimer's disease ans as controls from patients with Parkinson's disease and from patients without neurodegenerative disease

    Full Information

    First Posted
    February 28, 2018
    Last Updated
    March 30, 2020
    Sponsor
    Nantes University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03472183
    Brief Title
    Exploration of the Enteric Nervous System in Alzheimer Disease
    Acronym
    SYNEMA
    Official Title
    Exploration of the Enteric Nervous System in Alzheimer Disease : a Monocentric Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    no patients included
    Study Start Date
    April 26, 2018 (Actual)
    Primary Completion Date
    September 18, 2019 (Actual)
    Study Completion Date
    September 18, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nantes University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The close homology between the central and enteric nervous system suggests that a disease process affecting the central nervous system could also involve its enteric counterpart. This has already been demonstrated for patients with Parkinson's disease but needs to be proven for Alzheimer's disease. Studies on enteric nervous system during Alzheimer's disease are indeed in low number and don't have led to definite conclusion. The investigators thus propose to realize a complete analysis of the enteric nervous systems in Alzheimer's disease by studying the presence of "tau' protein, of beta-amyloid peptide,... not only by immunohistochemical but also by a biochemical approach. This study will be realized from colonic samples.
    Detailed Description
    The close homology between the central and enteric nervous system suggests that a disease process affecting the central nervous system could also involve its enteric counterpart. The investigators have recently shown in that the enteric neurons can be readily analyzed using routine colonic biopsies. The investigators propose that the enteric nervous system could represent a unique window to assess the neuropathology in living patients with a neurodegenerative disorder. The investigators have already used this approach to show that Parkinson's disease pathology was recapitulated in a single colonic biopsy. By contrast to Parkinson's disease, the detection of Alzheimer's disease pathology in the enteric neurons has so far failed. This may be due to the low number of human tissue samples in addition to the low sensitivity of the immunohistochemical methods that were used. The aim of the current research project will be therefore to reevaluate Alzheimer's disease pathology in a large number of human colonic samples using both a morphological and biochemical approach. The Hypothesis is that the enteric nervous system could represent a unique window to assess the neuropathology in living patients with Alzheimer's disease. This might open the way to the development of novel Alzheimer's disease biomarkers that will directly assess the neuropathological process.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease
    Keywords
    Enteric nervous system, Alzheimer disease, biomarker, colonic biopsies, neurodegenerative disease

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    3 types of patients will be included: 10 patients with Alzheimer's disease and as controls: 10 patients with Parkinson's disease 10 patients without neurodegenerative disease. During the course of the colonoscopy that these 30 patients should have in the context of their medical usual care, additionnal biopsies of colon will be removed to perform in vitro analysis for this study.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with Alzheimer's disease
    Arm Type
    Other
    Arm Description
    During the course of the colonoscopy that the patients should have in the context of their usual medical care, additional biopsies of colon will be removed to perform in vitro analysis for this study.
    Arm Title
    Patients with Parkinson's disease
    Arm Type
    Other
    Arm Description
    During the course of the colonoscopy that the patients should have in the context of their usual medical care, additional biopsies of colon will be removed to perform in vitro analysis for this study.
    Arm Title
    Patients without neurodegenerative disease
    Arm Type
    Other
    Arm Description
    During the course of the colonoscopy that the patients should have in the context of their usual medical care, additional biopsies of colon will be removed to perform in vitro analysis for this study.
    Intervention Type
    Other
    Intervention Name(s)
    biopsies of colon
    Intervention Description
    Removal of additional biopsies of colon during the course of a colonoscopy planned for usual medical follow-up of patient
    Primary Outcome Measure Information:
    Title
    Differences in extracellular deposits of beta-amyloid peptide in the enteric nervous system between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease.
    Description
    In vitro analysis of the presence of beta-amyloid peptide in biopsies of colon from patients with Alzheimer's disease ans as controls from patients with Parkinson's disease and from patients without neurodegenerative disease
    Time Frame
    colonoscopy performed within 3 months after inclusion in the study
    Secondary Outcome Measure Information:
    Title
    Differences in tau protein in the enteric nervous system between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease.
    Description
    In vitro analysis of the presence of tau protein in biopsies of colon from patients with Alzheimer's disease ans as controls from patients with Parkinson's disease and from patients without neurodegenerative disease
    Time Frame
    within 3 months after inclusion
    Title
    Differences in neuronal loss in enteric submucosal tissue between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease
    Description
    In vitro analysis of the presence of neuronal loss in biopsies of colon from patients with Alzheimer's disease ans as controls from patients with Parkinson's disease and from patients without neurodegenerative disease
    Time Frame
    within 3 months after inclusion
    Title
    Differences in neuronal Glia cells in the enteric nervous system between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease.
    Description
    In vitro analysis of the presence neuronal glia cells in biopsies of colon from patients with Alzheimer's disease ans as controls from patients with Parkinson's disease and from patients without neurodegenerative disease
    Time Frame
    within 3 months after inclusion

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: For the 3 groups of patients : colonoscopy planned by a gastroenterologist in the context ot the usual medical follow-up of the patient For patients with Alzheimer's disease : Patient with early to moderate Alzheimer disease (continuum of patients with mild cognitive impairment due to Alzheimer's disease and patients diagnosed with probable Alzheimer's disease) according to the National Institute of Aging-Alzheimer's Association (NIA AA) criteria Mini-Mental State Examination (MMSE) score ≥18; Has one informant or care partner; No parkinsonian syndrome No sign of lewy Body dementia For patients with Parkinson's disease: patients with Parkinson Disease according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria No dementia sign or cognitive deficit associated to Alzheimer's disease For patients without neurodegenerative disease: No history or current neurological/degenerative condition (e.g, lewy body dementia, Parkinson's disease, Parkinsonian syndrome, Alzheimer's disease,…) No memory complaint with a Mac Nair score ≤15 MMSE score ≥28 ; Patient at risk of colic cancer with a colonoscopy scheduled Exclusion Criteria: For the 3 groups of patients : : History of colonic disorder ((e.g inflammatory condition, adenocarcinoma) contra-indications to colonoscopy For patients with Alzheimer's disease and for patients with Parkinson's disease: - Any neurological/neurodegenerative condition different from the group to which it belongs (e.g other than Alzheimer's disease for Alzheimer's disease group or other than Parkinson's disease for Parkinson's disease group….) For patients without neurodegenerative disease: Any neurological/neurodegenerative condition (e.g lewy body dementia, Parkinsonian syndrome, Parkinson's disease, Alzheimer's disease..).. functional colopathy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pascal DERKINDEREN, Pr
    Organizational Affiliation
    Nantes University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Exploration of the Enteric Nervous System in Alzheimer Disease

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