Identifying blood microbiota differences in 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

This study is trying to see if the tiny germs in the blood of people with Alzheimer's disease are different from those in healthy people to help find new ways to understand and treat the condition.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 50 Years to 85 Years
• Sex: All
• Sponsor: University Hospital, Montpellier (Academic / other)
• Locations: 1 site (Montpellier)
• Trial ID: NCT04841135 on ClinicalTrials.gov

What this trial studies

This pilot study aims to compare the blood microbial signatures of Alzheimer's disease (AD) patients with those of healthy control subjects aged 50 to 85 years. Utilizing metagenomics and proteomics, the study will analyze the composition of microbiota in blood and stool samples, as well as the metabolomic profiles in plasma, stool, and urine. The goal is to validate differences in these signatures to propose innovative strategies for understanding and potentially treating Alzheimer's disease.

Who should consider this trial

Good fit: Ideal candidates include men and women aged 50-85 with a confirmed diagnosis of mild to moderate Alzheimer's disease.

Not a fit: Patients with severe Alzheimer's disease or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new diagnostic and therapeutic strategies for Alzheimer's disease based on blood microbiota profiles.

How similar studies have performed: While this approach is innovative, similar studies exploring the microbiota's role in neurological conditions have shown promising results, suggesting potential for success.

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

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:

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

Where this trial is running

Montpellier

• Montpellier university hospital — Montpellier, France (Recruiting)

Study contacts

• Principal investigator: Karim BENNYS, MD, PhD — Montpellier University Hospital
• Study coordinator: Karim BENNYS, MD, PhD

Conditions Alzheimer Disease; Elderly With Normal Cognition; Alzheimer; Memory; Aging; Microbiota