Exploring the Gut-Brain Axis in Ageing and Neurodegeneration
Launched by IRCCS SAN CAMILLO, VENEZIA, ITALY · Jul 5, 2023
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how the gut and brain communicate, particularly as we age and in the context of certain neurodegenerative diseases like Alzheimer's, Parkinson's, and Multiple Sclerosis. Researchers believe that changes in the bacteria in our gut might influence brain health and could serve as early warning signs for these conditions. The goal is to understand how the gut bacteria vary with normal aging and how imbalances in these bacteria relate to brain changes in neurodegenerative diseases.
To participate, individuals need to be in one of several groups: healthy young adults (ages 20-50), healthy older adults (ages 60-90), or those diagnosed with early Alzheimer's, Parkinson's, or Multiple Sclerosis. Participants will undergo a series of tests, including brain scans, stool and blood sample analyses, and memory assessments. It's important to note that certain medical conditions or recent treatments may exclude individuals from participating. This research could help us better understand the connection between gut health and brain function, potentially leading to new ways to detect and manage these diseases.
Gender
ALL
Eligibility 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
About Irccs San Camillo, Venezia, Italy
IRCCS San Camillo, located in Venice, Italy, is a renowned clinical research institute dedicated to advancing medical science through innovative research and high-quality clinical trials. As a recognized Institute of Hospitalization and Care for Scientific Research (IRCCS), it specializes in various fields, including neurology, psychiatry, and rehabilitation. With a commitment to improving patient outcomes, IRCCS San Camillo collaborates with national and international research networks, fostering a multidisciplinary approach to healthcare challenges. The institute emphasizes ethical standards and patient safety, ensuring that all trials adhere to rigorous regulatory guidelines while contributing valuable insights to the medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brescia, , Italy
Venice Lido, Venice, Italy
Venice, , Italy
Patients applied
Trial Officials
Nicola Filippini
Principal Investigator
IRCCS San Camillo, Venezia, Italy
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported