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

Alzheimer Disease Clinical Trial

— MiDCR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03487380
• Other study ID #: RC17_0162
• Secondary ID: 2017-A02246-47
• Status: Terminated
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: June 12, 2023

Study information

• Verified date: January 2024
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: June 12, 2023
• Est. primary completion date: June 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Intestinal Microbiota

Intervention

Procedure:
• Fecal sample collection
Fecal sample collection

Locations

Country	Name	City	State
France	CHU de Angers	Angers
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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
Secondary	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