RecruitingNCT05934188

Exploring the Gut-Brain Axis in Ageing and Neurodegeneration

Role of the Gut-microbiota on Ageing and Neurodegeneration: a Clinical and Brain Imaging Study


Sponsor

IRCCS San Camillo, Venezia, Italy

Enrollment

200 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

Neurodegenerative diseases are a major health concern due to their growing societal implications and economic costs. The identification of early markers of pathogenic mechanisms is one of the current main challenges. The gut-brain axis has become a primary target because of its transversal role across the neurodegenerative spectrum and its effect on cognition. However, despite recent progress, how changes in the gut-microbiota composition can affect the human brain is still unclear. The goal of this observational study is to characterise the gut-microbiota composition associated with alterations in brain structure and function during the ageing process and across neurodegenerative disorders. This is based on recent studies showing that changes in the human brain and in the microbiota composition, can indicate very sensitively and in a predictive way pathological development and, consequently, be used as markers of neurodegenerative diseases. The main questions it aims to answer are: * How variation in the gut-microbiota composition correlates with the normal brain ageing trajectory? * How dysregulation in the gut-microbiota correlates with pathological changes in brain regions in specific neurodegenerative disorders? * Can the impact of the gut-microbiota on the brain be modulated by blood biomarkers? The investigators will recruit 40 young healthy participants, 40 old healthy participants, 40 participants with prodromal Alzheimer's Disease, 40 participants with Parkinson's Disease and 40 participants with Multiple Sclerosis. Participants will undergo the following examinations: * Magnetic Resonance Imaging * Analysis of a stool sample * Analysis of a blood sample * Neuropsychological assessment * Questionnaires on eating habits


Eligibility

Min Age: 20 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring the connection between the gut and the brain in healthy people of different ages, as well as in people with early Alzheimer's disease or Parkinson's disease. Researchers want to understand how gut health may influence brain aging and neurodegeneration. **You may be eligible if...** - You are a healthy adult aged 20–50 or 60–90 with no significant neurological conditions, OR - You have early signs of Alzheimer's disease (mild memory complaints, functioning independently, MMSE score above 23), OR - You have a recent diagnosis of mild-to-moderate Parkinson's disease (cognitively healthy, stable medications for at least 6 months) **You may NOT be eligible if...** - You have significant cognitive problems beyond those listed above - You have uncontrolled neurological or psychiatric conditions - You do not meet the specific criteria for your group (healthy, Alzheimer's, or Parkinson's) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMagnetic Resonance Imaging

The Magnetic Resonance Imaging protocol will comprise both structural and functional sequences.

BEHAVIORALNeuropsychological protocol

Neuropsychological tests will be administered to participants to assess general cognitive state and a range of high-level cognitive functions (memory, executive, language). In addition, disease-specific tests will be administered to patients to investigate disease staging and the level of disability and autonomy.

BEHAVIORALEating habits

Information on eating habits will be derived from food questionnaires.

DIAGNOSTIC_TESTMicrobiome analyses

The Microbiome analyses will be derived from a stool sample (16S rRNA sequencing targeted metagenomic analyses).

DIAGNOSTIC_TESTInflammatory markers

Inflammatory markers will be evaluated in terms RNA expression level in plasma blood sample.

DIAGNOSTIC_TESTAlzheimer's Disease biomarkers

The Alzheimer's Disease biomarkers will be measured in the plasma of prodromal Alzheimer's Disease patients.


Locations(3)

IRCCS San Camillo

Venice-Lido, Venice, Italy

IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli

Brescia, Italy

Università Ca' Foscari Venezia

Venice, Italy

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NCT05934188


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