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Trial record 19 of 461 for:    Recruiting, Not yet recruiting, Available Studies | "Alzheimer Disease"

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

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ClinicalTrials.gov Identifier: NCT03472183
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: biopsies of colon Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Basic Science
Official Title: Exploration of the Enteric Nervous System in Alzheimer Disease : a Monocentric Pilot Study
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : April 26, 2020
Estimated Study Completion Date : August 25, 2020


Arm Intervention/treatment
Patients with Alzheimer's disease
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.
Other: biopsies of colon
Removal of additional biopsies of colon during the course of a colonoscopy planned for usual medical follow-up of patient

Patients with Parkinson's disease
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.
Other: biopsies of colon
Removal of additional biopsies of colon during the course of a colonoscopy planned for usual medical follow-up of patient

Patients without neurodegenerative disease
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.
Other: biopsies of colon
Removal of additional biopsies of colon during the course of a colonoscopy planned for usual medical follow-up of patient




Primary Outcome Measures :
  1. 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. [ Time Frame: colonoscopy performed within 3 months after inclusion in the study ]
    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 :
  1. 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. [ Time Frame: within 3 months after inclusion ]
    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

  2. Differences in neuronal loss in enteric submucosal tissue between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease [ Time Frame: within 3 months after inclusion ]
    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

  3. 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. [ Time Frame: within 3 months after inclusion ]
    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



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03472183


Contacts
Contact: Pascal DERKINDEREN, Pr +33 2 40 16 52 02 pascal.derkinderen@chu-nantes.fr

Locations
France
Nantes university Hospital Recruiting
Nantes, France, 44093
Contact: Pascal DERKINDEREN, Professor    +33 2 40 16 52 02    pascal.derkinderen@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Pascal DERKINDEREN, Pr Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03472183     History of Changes
Other Study ID Numbers: RC17_0252
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
Enteric nervous system
Alzheimer disease
biomarker
colonic biopsies
neurodegenerative disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders