Enteric Nervous System in Alzheimer Disease
ENTEROMA
1 other identifier
interventional
55
1 country
1
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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Oct 2016
Typical duration for not_applicable alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2016
CompletedFirst Posted
Study publicly available on registry
July 22, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedJuly 22, 2016
July 1, 2016
2.6 years
July 19, 2016
July 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of alpha-synuclein aggregates in colonic biopsies using immunohistochemistry
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.
4 months
Study Arms (4)
AD group
OTHERAD group: rectosigmoidospcopy with biopsies of colon
PD group
OTHERPD group: rectosigmoidospcopy with biopsies of colon
PSP group
OTHERPSP group: rectosigmoidospcopy with biopsies of colon
Patient eligible for colorectal cancer screening
OTHERPatient eligible for colorectal cancer screening: colonoscopy with biopsies of colon
Interventions
Rectosigmoidoscopy with colonic biopsies performed for Alzheimer patient and both control groups Parkinson and PSP
Colonoscopy with colonic biopsies performed only in patient at risk of colic cancer
Eligibility Criteria
You may qualify if:
- \- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Nantes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2016
First Posted
July 22, 2016
Study Start
October 1, 2016
Primary Completion
May 1, 2019
Study Completion
May 1, 2019
Last Updated
July 22, 2016
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share