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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2023-06-12

Brief Summary

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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

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Detailed Description

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Conditions

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Alzheimer Disease Intestinal Microbiota

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Alzheimer with rapid DCR

Group Type EXPERIMENTAL

Fecal sample collection

Intervention Type PROCEDURE

Fecal sample collection

Alzheimer without rapid DCR

Group Type EXPERIMENTAL

Fecal sample collection

Intervention Type PROCEDURE

Fecal sample collection

Control

Group Type SHAM_COMPARATOR

Fecal sample collection

Intervention Type PROCEDURE

Fecal sample collection

Interventions

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Fecal sample collection

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No