Analysis of the Blood Signature of the Microbiota as a Diagnostic Marker of Alzheimer's Disease in the Early Stages of the Process: Pilot Study

University Hospital, Montpellier1 site in 1 country120 target enrollmentJune 3, 2021

ConditionsAlzheimer Disease Elderly With Normal Cognition

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Alzheimer Disease
Sponsor: University Hospital, Montpellier
Enrollment: 120
Locations: 1
Primary Endpoint: Concentration of bacterial 16S rDNA in stools
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to validate a difference in blood microbial signature between Alzheimer's patients and control subjects in order to propose potential innovative strategies

Detailed Description

This is a pilot study only carried out in Montpellier, aimed at comparing AD patients with control subjects, including men / women aged between 50 and 85 years. The diagnosis of AD patients is based on international criteria. Metagenomics and proteomics will be used to determine the composition of the microbiota in whole blood and stools, but also the metabolomic profile in plasma, stool and the urines.

Registry

clinicaltrials.gov

Start Date

June 3, 2021

End Date

January 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General criteria for AD and control groups:
•Male and/or female;
•Age between 50-85 years;
•Having given their free, informed, written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
•Patient benefiting from a social security scheme
•Diagnosis of Alzheimer's disease according to the international ATN criteria of Albert et al, (1) who had a diagnostic lumbar puncture and CSF biomarker assay and brain imaging with analysis of hippocampal atrophy; topographic and pathophysiological markers must be positive to confirm the etiopathogenic diagnosis;
•Mild to moderate stage with MMSE score between 10 and 26 ;
•Symptomatic treatments specific to Alzheimer's disease (acetylcholinesterase inhibitors and memantine) and psychotropic treatments (anxiolytics, antidepressants, neuroleptics) are authorized but must be at fixed doses for more than 3 months ;
•Control group:
•Patients seen in memory consultation for concern of having AD but for whom the workup is normal. These patients will have had a diagnostic lumbar puncture during the same memory consultation.