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

Primary Purpose

Alzheimer Disease, Intestinal Microbiota

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Fecal sample collection
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Angers
  • CHU de NantesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Alzheimer with rapid DCR

Alzheimer without rapid DCR

Control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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

Full Information

First Posted
March 27, 2018
Last Updated
April 29, 2019
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03487380
Brief Title
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
Acronym
MiDCR
Official Title
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Intestinal Microbiota

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will compare three groups of 100 patients, corresponding to 200 patients with Alzheimer disease (whom 100 patients in the rapid cognitive decline group and 100 patients without rapid cognitive decline) and 100 patients in the control group.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer with rapid DCR
Arm Type
Experimental
Arm Title
Alzheimer without rapid DCR
Arm Type
Experimental
Arm Title
Control
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Fecal sample collection
Intervention Description
Fecal sample collection
Primary Outcome Measure Information:
Title
analysis of the taxonomic and functional composition of the microbiome
Description
("shotgun sequencing"), in patients with DCR (loss of at least 3 points in the MMSE at 1 year.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laure de Decker, Pr
Phone
02 40 16 50 46
Email
laure.dedecker@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Chapelet, Dr
Email
guillaume.chapelet@chu-nantes.fr
Facility Information:
Facility Name
CHU de Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cedric Annweiler, Dr
Email
Annweiler@chu-angers.fr
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laure De Decker, Pr
Email
laure.dedecker@chu-nantes.fr

12. IPD Sharing Statement

Learn more about this trial

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

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