Investigating the connection between gut health and brain function in aging and neurodegenerative diseases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore how changes in gut microbiota may influence brain structure and function during aging and in neurodegenerative diseases such as Alzheimer's, Parkinson's, and Multiple Sclerosis. By recruiting both healthy individuals and patients with specific conditions, the study will utilize advanced MRI techniques alongside biological assessments to identify potential biomarkers linked to cognitive decline. The research focuses on understanding the gut-brain axis and its role in neurodegeneration, with the goal of characterizing unique microbiota profiles associated with different disorders.

Why it matters

Who can join: the full rules

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

For both healthy participants and patients:

* Contraindications to magnetic resonance imaging (metal implant in body, known claustrophobia, pacemakers)
* Severe comorbidities
* Antibiotics treatments over the last 3 months

Where it's running

• IRCCS San Camillo
  Venice-Lido, Venice, Italy Recruiting
• IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli
  Brescia, Italy Recruiting
• Università Ca' Foscari Venezia
  Venice, Italy Recruiting

Study contacts

• Principal investigator: Nicola Filippini — IRCCS San Camillo, Venezia, Italy
• Study coordinator: Nicola Filippini
• Email: nicola.filippini@hsancamillo.it
• Phone: +39 041 2207304

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.