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RecruitingNCT04841135MICMALZUpdated Apr 20, 2023

Blood Microbiota Signature of Alzheimer's Disease

An interventional study of Multiomics quantification and Polysomnography in Alzheimer Disease and Elderly With Normal Cognition, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to participants aged 50 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-20.

Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 6 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
50 Years to 85 Years
Sex
All
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Study 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

Read the 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.

02

Conditions studied

  • Alzheimer Disease
  • Elderly With Normal Cognition

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Keywords

  • Alzheimer
  • Memory
  • Aging
  • Microbiota
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 120 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts 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:

  • 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.

Neurotypical group criteria:

  • Male and/or female ;
  • Age between 18-35 years or between 50-85 years;
  • Having given their free, informed, written and signed consent by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
  • Patients without cognitive complaints seen in memory consultation but for whom the assessment is normal or young subjects recruited by advertisement. These participants will have an ex-post determination of plasma Aß and tau biomarkers.

Exclusion 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 ;
  • Presence of inflammatory bowel disease or other familial gastrointestinal pathology ;
  • Chronic use of laxatives;
  • Antibiotics taken within one month prior to inclusion;
  • Short-term life-threatening conditions (active cancer, unstable heart failure, severe liver, kidney and respiratory failure);
  • Chronic psychosis or psychotic episodes;
  • Alcohol or drug addiction;
  • Epilepsy and other non-degenerative diseases of the central nervous system
  • Vitamin B12 deficiency and unsupplemented folic acid ;
  • Untreated hypothyroidism;
  • Patient deprived of liberty, by judicial or administrative decision;
  • Major protected by law;
  • Patient in a period of relative exclusion from another protocol;
  • Refusal to participate in the protocol.

AD group :

  • Insufficient clinical and paraclinical information for the diagnosis of AD;
  • Genetic form of AD (known genetic mutation);

Control and neurotypical groups: No specific non-inclusion criteria

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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    Alzheimer disease group

    Other: Multiomics quantification · Other: Polysomnography

  • Other
    Control

    Other: Multiomics quantification · Other: Polysomnography

  • Other
    Neurotypicals

    Other: Multiomics quantification

Interventions

  • OtherMultiomics quantification

    One time blood, stool and urine samples will be taken.

  • OtherPolysomnography

    Facultative polysomnography

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What researchers measure

Primary outcomes

  1. Concentration of bacterial 16S rDNA in stools

    Concentration of bacterial 16S rDNA in stools

    Time frame: 22 months

Secondary outcomes

  1. Concentration of bacterial 16s DNA in blood

    Concentration of bacterial 16s DNA in blood

    Time frame: 22 months

  2. Multiomics microbiota signature in AD

    Multiomics microbiota signature in AD

    Time frame: 22 months

07

Study locations

1 of 1 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04841135
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Apr 12, 2021
Start date
Jun 3, 2021
Primary completion
Apr 2024 (estimated)
Completion
Jan 2026 (estimated)
Last update
Apr 20, 2023

Study contacts

Karim BENNYS, MD, PhD
Contact
k-bennys@chu-montpellier.fr
+33 4 67 33 72 32
Sylvie CLAEYSEN
Contact
sylvie.claeysen@igf.cnrs.fr
+33 4 34 35 92 15
Karim BENNYS, MD, PhD
principal investigator · Montpellier University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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