Loading clinical trials...

UNKNOWNNA

Blood Microbiota Signature of Alzheimer's Disease

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

NCT04841135•University Hospital, Montpellier

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 85 years

Sex

ALL

Healthy Volunteers

Yes

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
•AD group:
•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:
+6 more criteria

Exclusion Criteria

•General criteria for AD and control groups:
•Absence of a family caregiver to complete the neuropsychological scales and questionnaires ;
•Patient living in a medical institution;
•Illiteracy or inability to complete the psycho-behavioral tests;
•Major physical or neurosensory problems likely to interfere with the tests;
•Contra-indication or refusal to perform the biological tests;
•Refusal to carry out neuropsychological tests.
•Refusal of stool collection
•Digestive neoplasia in progress or \< 5 years old
•Digestive surgery with intestinal resection ;
+16 more criteria

Locations (1)

Montpellier university hospital

Montpellier, France

Key Dates

Start Date

June 3, 2021

Primary Completion Date

April 1, 2024

Completion Date

January 1, 2026

Last Updated

April 20, 2023

Enrollment

120

ESTIMATED participants

Conditions

Alzheimer DiseaseElderly With Normal Cognition

Interventions

Multiomics quantification

OTHER

Polysomnography

OTHER

Contacts

Karim BENNYS, MD, PhD

CONTACT

+33 4 67 33 72 32 k-bennys@chu-montpellier.fr

Sylvie CLAEYSEN

CONTACT

+33 4 34 35 92 15 sylvie.claeysen@igf.cnrs.fr

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

NCT07178210

Alzheimer DiseaseLymphatic Obstruction

View study

RECRUITINGEARLY_PHASE1

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

NCT04123314

Depressive SymptomsDepression+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Blood Microbiota Signature of Alzheimer's Disease

Inclusion Criteria

Exclusion Criteria

Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease

Psilocybin for Depression in People With Mild Cognitive Impairment or Early Alzheimer's Disease

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

A Trial to Evaluate the Safety and Efficacy of Benfotiamine in Patients With Early Alzheimer's Disease (BenfoTeam)

Longitudinal Early-onset Alzheimer's Disease Study Protocol

A Study of AMDX-2011P in Participants With Alzheimer's Disease