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Search / Trial NCT05934188

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

Mri Microbiota Stool Sample Blood Sample Neuropsychological Assessment Neuroimaging Biomarkers For Brain Disorders

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.

Locations

Brescia, , Italy

Venice Lido, Venice, Italy

Venice, , Italy

Patients applied

0 patients applied

Trial Officials

Nicola Filippini

Principal Investigator

IRCCS San Camillo, Venezia, Italy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported