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

Not Applicable

Terminated

• Conditions: Alzheimer Disease; Intestinal Microbiota
• Interventions: Procedure: Fecal sample collection

• Registration Number: NCT03487380
• Lead Sponsor: Nantes University Hospital

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-04
• Study First Submitted: 2018-03-27
• Study First Submitted QC: 2018-03-27
• Study First Posted: 2018-04-04
• Primary Completion: 2023-06-12
• Study Completion: 2023-06-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 86

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alzheimer with rapid DCR	Fecal sample collection	-
Alzheimer without rapid DCR	Fecal sample collection	-
Control	Fecal sample collection	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.	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	1 year

Trial Locations

Locations (2)

CHU de Angers; 🇫🇷 Angers, France

CHU de Nantes; 🇫🇷 Nantes, France