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WithdrawnNCT03472183SYNEMAUpdated Jun 24, 2026

Exploration of the Enteric Nervous System in Alzheimer Disease

An interventional study of biopsies of colon in Alzheimer Disease, sponsored by Nantes University Hospital. Withdrawn. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Basic science

Why this study was withdrawn
no patients included

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Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alzheimer Disease

Keywords

  • Enteric nervous system
  • Alzheimer disease
  • biomarker
  • colonic biopsies
  • neurodegenerative disease
03

In context

Alzheimer Disease

3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.

Browse Alzheimer Disease studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 839 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • (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

Exclusion Criteria:

For the 3 groups of patients : :

  • History of colonic disorder ((e.g inflammatory condition, adenocarcinoma)
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    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

  • Other
    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

  • Other
    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

Interventions

  • Otherbiopsies of colon

    Removal of additional biopsies of colon during the course of a colonoscopy planned for usual medical follow-up of patient

06

What researchers measure

Primary outcomes

  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.

    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 outcomes

  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.

    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

  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

    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

  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.

    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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2018 to primary completion in Sep 2019, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 28, 2018
First posted
Mar 21, 2018
StartActual
Apr 26, 2018
Primary completionActual
Sep 18, 2019
CompletionActual
Sep 18, 2019
Last update
Jun 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03472183
Responsible party
Sponsor
First posted
Mar 21, 2018
Start date
Apr 26, 2018
Primary completion
Sep 18, 2019
Completion
Sep 18, 2019
Last update
Jun 24, 2026

Study contacts

Pascal DERKINDEREN, Pr
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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