NCT06824285 Evaluation of Electroencephalographic Biomarkers in Physiological Aging
| NCT ID | NCT06824285 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele Roma |
| Condition | Aging |
| Study Type | OBSERVATIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-10-20 |
| Primary Completion | 2026-04-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 96 participants in total. It began in 2023-10-20 with a primary completion date of 2026-04-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aging is the inevitable biological process that results in a progressive structural and functional decline from the cellular level to whole body function. It is associated with functional changes in the resting brain activity, brain morphology, plasticity, complexity and function. Moreover, aging is the main risk factor for neurodegenerative disease. Understanding the molecular mechanisms underlying the age-related neurophysiological changes and identifying novel biomarkers of healthy brain ageing is thus instrumental for the development of efficient interventions against age-related motor/cognitive impairments. Within this context, there is now a significant literature establishing the enhanced efficacy of secreted exosomes over the stem cells from which they are derived when used as a possible treatment for neurodegenerative disorders. Exosomes are a subgroup of extracellular vesicles which regulate intercellular communication and, unlike stem cells, easily cross into the brain and can be administered in non-syngeneic species without immune rejection. Studies on brain ageing in humans has major limitation in the lack of accessibility of the central nervous system. EEG has allowed the non-invasive assessment of functional changes in the aging brain. In fact, this technique can provide a direct assessment of neural activity and information flow with a higher temporal resolution that is particularly important for investigating the dynamics of brain changes underlying cognitive processing and age-related changes, providing novel biomarkers of brain aging that could be used to unveil differences between healthy and unhealthy processes particularly in the pre-symptomatic and pre-clinical stage. To reach this aim, it is necessary to demonstrate, in experimental models, the relationship between age-dependent changes in brain activity and cellular/molecular processes occurring in aged brain. Our project will pursue this overall goal by: 1\) identifying neurophysiological biomarkers of brain aging in human subjects based on functional network and complexity analyses; 2) characterizing age-dependent changes in brain connectivity and complexity in mice and correlating them to changes in motor and cognitive performances and to molecular alterations occurring in both the brain and blood; 3) evaluating changes of the identified electrophysiological and molecular biomarkers in mice treated with stem cell derived exosomes for the rejuvenation of the aged brain. 4\) designing Artificial Intelligence (AI) predictor of brain age trajectories on individual basis to evaluate individual neural reserve and resilience. This study will identify novel electrophysiological biomarkers of healthy brain ageing and will advance knowledge on cellular/molecular signature of brain aging that could targeted for the preservation of brain health.
Eligibility Criteria
Inclusion Criteria: * healthy subjects * \> 18 years old Exclusion Criteria: * neurological disorders * head injuries, * substance abuse, * psychiatric conditions * any medications affecting the cardiovascular or central nervous systems
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06824285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06824285 currently recruiting?
Yes, NCT06824285 is actively recruiting participants. Contact the research team at lucia.gatta@sanraffaele.it for enrollment information.
Where is the NCT06824285 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT06824285 clinical trial?
NCT06824285 is sponsored by IRCCS San Raffaele Roma. The trial plans to enroll 96 participants.