Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease (MiDCR)

January 31, 2024 updated by: Nantes University Hospital
The objective of the study is to highlight a modification of the composition of the intestinal microbiota associated with the diagnosis of Alzheimer's disease and its most unfavorable form, Rapid Cognitive Decline (DCR). This identification could lead to diagnostic strategies based on the analysis of the intestinal microbiome, and preventive and curative treatments, based on the modulation of intestinal microbiota

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • CHU de Angers
      • Nantes, France, 44000
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

For Alzheimer groups without DCR and Alzheimer with DCR:

  • patients between 70 and 90 years old
  • with mild to moderate Alzheimer's disease (MMSE> 15/30),
  • followed in the CMRR of the University Hospital of Nantes or Angers
  • having given their informed consent

For the control group (non-Alzheimer's)

  • more patients between 70 and 90 years
  • consultant for a subjective memory complaint isolated at the CMRR of Nantes or Angers University Hospital,
  • having given their informed consent

Exclusion Criteria:

  • Major patients under tutorship, curatorship or safeguard of justice
  • Cognitive disorders possibly related to a metabolic or psychiatric cause
  • History of prescription of antibiotic treatment in the last month
  • History of acute gastrointestinal illness in the last month
  • History of hospitalization for an acute medical pathology or for a surgical procedure in the last month

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control
Procedure: Fecal sample collection
Fecal sample collection
Experimental: Alzheimer with rapid DCR
Procedure: Fecal sample collection
Fecal sample collection
Experimental: Alzheimer without rapid DCR
Procedure: Fecal sample collection
Fecal sample collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
analysis of the taxonomic and functional composition of the microbiome
Time Frame: 1 year
("shotgun sequencing"), in patients with DCR (loss of at least 3 points in the MMSE at 1 year.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
to determine if there is a specific modification of the composition of the intestinal microbiota of patients with Alzheimer's disease, compared to control group.
Time Frame: Day 0
Day 0
create a prognostic score of DCR based on clinical data, including the responses to the MMSE, BREF and MNA questionnaires, and taking into account the microbiota analysis
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2017

Primary Completion (Actual)

June 12, 2023

Study Completion (Actual)

June 12, 2023

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

March 27, 2018

First Posted (Actual)

April 4, 2018

Study Record Updates

Last Update Posted (Actual)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC17_0162
  • 2017-A02246-47 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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