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NCT05934188Recruiting

Exploring the Gut-Brain Axis in Ageing and Neurodegeneration

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

Source: ClinicalTrials.gov · Last updated 9 Jan 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
9 Jun 2023
Start date
1 May 2023
Primary completion date
30 Apr 2027
Lead sponsor
IRCCS San Camillo, Venezia, Italy
NCT number
NCT05934188

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 1 May 2023 to the primary completion date, 30 Apr 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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

Other

  • For both healthy participants and patients:
  • Severe comorbidities
  • Antibiotics treatments over the last 3 months

Who the study is looking for

  • Healthy Young and Old Subjects:
  • 20-50 or 60-90 years old
  • Cognitively healthy (Mini-Mental State examination ≥ 26)
  • Absence of significant neurological disorders
    • Patients with prodromal Alzheimer's Disease:
  • Subjective cognitive complaint (corroborated by the informant)
  • Episodic memory deficit on neuropsychological testing
  • Clinical Dementia Rating = 0.5
  • Mini-Mental State Examination (MMSE) \> 23
  • Independently functioning in activities of daily living
    • Patients with Parkinson's Disease:
  • Recent diagnosis of Parkinson's Disease
  • Mild-moderate score at the Unified Parkinson's Disease Rating Scale (UPDRS)
  • Cognitively healthy (Mini-Mental State examination ≥ 26)
  • In case of taking medications for Parkinson's Disease: stable dosage for at least 6 months
    • Patients with Multiple Sclerosis:
  • Recent diagnosis of relapsing-remitting Multiple Sclerosis
  • Expanded Disability Status Scale score ≤ 4.0
  • Cognitively healthy (Mini-Mental State examination ≥ 26)
  • In case of taking medications for Multiple Sclerosis: stable dosage for at least 6 months.

Age in the registry: 20 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
Coordinator of this site? Confirm its status
BresciaItalyRecruiting
Università Ca' Foscari Venezia
Coordinator of this site? Confirm its status
VeniceItalyRecruiting
IRCCS San Camillo
Coordinator of this site? Confirm its status
Venice-LidoItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.