Health TrialsbyHealthPanel

Exploring the Gut-Brain Axis in Ageing and Neurodegeneration

ConditionsHealthyProdromal Alzheimer's DiseaseParkinson DiseaseMultiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-90
SponsorIRCCS San Camillo, Venezia, Italy

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

20-50 or 60-90 years old

Cognitively healthy (Mini-Mental State examination ≥ 26)

Absence of significant neurological disorders

Subjective cognitive complaint (corroborated by the informant)

Disqualifiers

Contraindications to magnetic resonance imaging (metal implant in body, known claustrophobia, pacemakers)

Severe comorbidities

Antibiotics treatments over the last 3 months

Trial population

The groups will be selected from local community sample, hospital and general practitioners (gp).

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Magnetic Resonance Imaging

    Diagnostic test

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

  • Neuropsychological protocol

    Behavioral

    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.

  • Eating habits

    Behavioral

    Information on eating habits will be derived from food questionnaires.

  • Microbiome analyses

    Diagnostic test

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

  • Inflammatory markers

    Diagnostic test

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

  • Alzheimer's Disease biomarkers

    Diagnostic test

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

Treatment groups

200 Participants
are divided into 5 treatment groups
Group A: Young Healthy Subjects (N = 40)5 interventions
Group B: Old Healthy Subjects (N = 40)5 interventions
Group C: Patients with prodromal Alzheimer's Disease (N = 40)6 interventions
Group D: Patients with Parkinson's Disease (N = 40)5 interventions
Group E: Patients with Multiple Sclerosis (N = 40)5 interventions

Trial outcomes

Primary outcomes

1

Brain structural and functional properties

Brain structural and functional properties will be derived from a multi-modal Magnetic Resonance Imaging protocol.

Time frame
Day 1
2

Microbiome profile

Microbiome profile will be derived from a stool sample obtained from participants.

Time frame
Day 1

Secondary outcomes

1

Cognitive functioning

Cognitive functions will be measured using a neuropsychological protocol.

Time frame
Day 1
2

Concentration of blood inflammatory markers

A panel of key inflammatory mediators (for example, IFNgamma, IL-6, TNFalpha, IL1beta, IL10) will be evaluated in terms RNA expression level in plasma samples obtained from participants.

Time frame
Day 1
3

Eating habits

Information on eating habits will be derived from food questionnaires.

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS San Camillo, Venezia, Italy

Lead sponsor

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Collaborator

Università Ca' Foscari Venezia

Collaborator

Source ClinicalTrials.gov
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