Investigating the connection between gut health and brain function in aging and neurodegenerative diseases
Role of the Gut-microbiota on Ageing and Neurodegeneration: a Clinical and Brain Imaging Study
This study is trying to see how changes in gut health might affect brain function in older adults and those with diseases like Alzheimer's and Parkinson's.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | IRCCS San Camillo, Venezia, Italy Academic / other |
| Locations | 3 sites (Venice-Lido, Venice and 2 other locations) |
| Trial ID | NCT05934188 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 20-50 or 60-90, as well as patients with prodromal Alzheimer's Disease, Parkinson's Disease, or relapsing-remitting Multiple Sclerosis.
Not a fit: Patients with significant neurological disorders other than the specified conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of early biomarkers for neurodegenerative diseases, potentially improving diagnosis and treatment strategies.
How similar studies have performed: While the gut-brain axis is a growing area of interest, this specific approach to characterizing microbiota in relation to neurodegenerative diseases is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Venice-Lido, Venice and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.