Exploring the Gut-Brain Axis in Ageing and Neurodegeneration
Recruiting · NCT05934188 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS San Camillo, Venezia, Italy
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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 is running
3 locations listed.
- IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli - Brescia, Italy
- Università Ca' Foscari Venezia - Venice, Italy
- IRCCS San Camillo - Venice-Lido, Venice, Italy