NCT04841135

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 3, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

April 20, 2023

Status Verified

April 1, 2023

Enrollment Period

2.8 years

First QC Date

April 8, 2021

Last Update Submit

April 18, 2023

Conditions

Alzheimer DiseaseElderly With Normal Cognition

Keywords

AlzheimerMemoryAgingMicrobiota

Outcome Measures

Primary Outcomes (1)

  • Concentration of bacterial 16S rDNA in stools

    Concentration of bacterial 16S rDNA in stools

    22 months

Secondary Outcomes (2)

  • Concentration of bacterial 16s DNA in blood

    22 months

  • Multiomics microbiota signature in AD

    22 months

Study Arms (3)

Alzheimer disease group

OTHER
Other: Multiomics quantificationOther: Polysomnography

Control

OTHER
Other: Multiomics quantificationOther: Polysomnography

Neurotypicals

OTHER
Other: Multiomics quantification

Interventions

Multiomics quantificationOTHER

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

Alzheimer disease groupControlNeurotypicals
PolysomnographyOTHER

Facultative polysomnography

Alzheimer disease groupControl

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • General criteria for AD and control groups:
  • Male and/or female;
  • Age between 50-85 years;
  • 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;
  • 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.

You may not qualify if:

  • 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;
  • 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;
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montpellier university hospital

Montpellier, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Karim BENNYS, MD, PhD

    Montpellier University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karim BENNYS, MD, PhD

CONTACT

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

Sylvie CLAEYSEN

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2021

First Posted

April 12, 2021

Study Start

June 3, 2021

Primary Completion

April 1, 2024

Study Completion

January 1, 2026

Last Updated

April 20, 2023

Record last verified: 2023-04

Locations

FR(1)