NCT03472183

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Status
withdrawn

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

February 28, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 21, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

April 26, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2019

Completed
Last Updated

April 1, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

February 28, 2018

Last Update Submit

March 30, 2020

Conditions

Alzheimer Disease

Keywords

Enteric nervous systemAlzheimer diseasebiomarkercolonic biopsiesneurodegenerative disease

Outcome Measures

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

    colonoscopy performed within 3 months after inclusion in the study

Secondary Outcomes (3)

  • 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.

    within 3 months after inclusion

  • Differences in neuronal loss in enteric submucosal tissue between patients with Alzheimer's disease, patients with Parkinson's disease and patients without neurodegenerative disease

    within 3 months after inclusion

  • 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.

    within 3 months after inclusion

Study Arms (3)

Patients with Alzheimer's disease

OTHER

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

Patients with Parkinson's disease

OTHER

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

Patients without neurodegenerative disease

OTHER

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

biopsies of colonOTHER

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

Patients with Alzheimer's diseasePatients with Parkinson's diseasePatients without neurodegenerative disease

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer DiseaseNeurodegenerative Diseases

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurocognitive DisordersMental Disorders

Study Officials

  • Pascal DERKINDEREN, Pr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 21, 2018

Study Start

April 26, 2018

Primary Completion

September 18, 2019

Study Completion

September 18, 2019

Last Updated

April 1, 2020

Record last verified: 2020-03