Exploring the Gut-Brain Axis in Ageing and Neurodegeneration (NCT05934188) | Clinical Trial Compass
RecruitingNot Applicable
Exploring the Gut-Brain Axis in Ageing and Neurodegeneration
Italy200 participantsStarted 2023-05-01
Plain-language summary
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 participate
Age range
20 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.