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Enteric Nervous System in Alzheimer Disease (ENTEROMA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02841605
Recruitment Status : Unknown
Verified July 2016 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief Summary:

The close homology between the central and enteric nervous systems 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. This led us to 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 (AD) 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 AD pathology in a large number of human colonic samples using both a morphological and biochemical approach .

The enteric nervous system could represent a unique window to assess the neuropathology in living patients with AD. This might open the way to the development of novel AD biomarkers that will directly assess the neuropathological process.

Main Aim : To Analyze the presence of beta-amyloid pathology in the enteric nervous system (ENS) in AD patients

Secondary Aim(s):

  1. To analyze and describe the presence of tau in the enteric nervous system (ENS) in AD patients
  2. To assess neuronal loss in submucosal tissue in AD patients.
  3. To examine Glia cells in the enteric nervous system in AD patients..

Condition or disease Intervention/treatment Phase
Alzheimer Disease Procedure: Rectosigmoidoscopy with colonic biopsies Procedure: Colonoscopy with colonic biopsies Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Enteric Nervous System in Alzheimer Disease
Study Start Date : October 2016
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
AD group
AD group: rectosigmoidospcopy with biopsies of colon
 Procedure: Rectosigmoidoscopy with colonic biopsies
Rectosigmoidoscopy with colonic biopsies performed for Alzheimer patient and both control groups Parkinson and PSP
PD group
PD group: rectosigmoidospcopy with biopsies of colon
 Procedure: Rectosigmoidoscopy with colonic biopsies
Rectosigmoidoscopy with colonic biopsies performed for Alzheimer patient and both control groups Parkinson and PSP
PSP group
PSP group: rectosigmoidospcopy with biopsies of colon
 Procedure: Rectosigmoidoscopy with colonic biopsies
Rectosigmoidoscopy with colonic biopsies performed for Alzheimer patient and both control groups Parkinson and PSP
Patient eligible for colorectal cancer screening
Patient eligible for colorectal cancer screening: colonoscopy with biopsies of colon
 Procedure: Colonoscopy with colonic biopsies
Colonoscopy with colonic biopsies performed only in patient at risk of colic cancer


Outcome Measures
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Primary Outcome Measures :
  1. Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry [ Time Frame: 4 months ]
    Alpha synuclein will be analysed by means of immunohistochemistry in colonic biopsy of patients with Alzheimer disease contrasted to patients with Parkinson disease, progressive supranuclear palsy and to patients eligible for colorectal cancer screening, as a possible biomarker of AD mirroring the cerebral anomaly.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- AD group : Patient with early to moderate Alzheimer disease (continuum of patients with MCI due to AD and patients diagnosed with probable AD) according to NIA NAA criteria MMSE score ≥18; Has one informant or care partner; No parkinsonian syndrome No sign of lewy Body dementia

- PD group (control group 1) : Patients with Parkinson Disease according UKPDSBB criteria, No dementia sign or cognitive deficit associated to AD

- PSP group (control group 2): Patients with possible or probable Progressive supranuclear palsy group PSP according to NINDS criteria Has one informant or care partner;

- Patient eligible for colorectal cancer screening (control group 3) : No history or current neurological/degenerative condition (e.g, lewy body dementia, PD, Parkinsonian syndrome, AD…) 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 all groups: History of colonic disorder (e.g inflammatory condition, adenocarcinoma) History of bleeding disorder Traitement anticoagulant ou antiagrégant en cours Treatment with anticoagulant or Platelet aggregation inhibiting drugs

- Patient with AD, PSP, PD: Any neurological/neurodegenerative condition different from the group to which it belongs (e.g other than AD for AD group or other than PD for PD group….)

- Patient eligible for colorectal cancer screening Any neurological/neurodegenerative condition (e.g lewy body dementia, Parkinsonian syndrome, PD, AD..)..

Functional colopathy or Irritable Bowel Syndrome

Contacts and Locations
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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): NCT02841605


Contacts
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Contact: Pascal Derkinderen, Professor (33) 2 40 16 52 02 Pascal.derkinderen@chu-nantes.fr
Contact: Laetitia Barbin (33) 2 40 16 59 42 laetitia.barbin@chu-nantes.fr

Locations
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France
University Hospital
Nantes, France
Contact: Pascal Derkinderen, Professor    (33) 2 40 16 52 02,    Pascal.derkinderen@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02841605    
Other Study ID Numbers: RC15_0458
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders