NCT06746909 Identification of Neuroinflammation and Neuroimaging Biomarkers Through Data Driven Artificial Intelligence Techniques for Unraveling the Heterogeneity of Aged Subjects at Risk of Dementia and to Better Inform Prevention Strategies
| NCT ID | NCT06746909 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Fondazione Stella Maris |
| Condition | MCI |
| Study Type | INTERVENTIONAL |
| Enrollment | 115 participants |
| Start Date | 2022-02-01 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 115 participants in total. It began in 2022-02-01 with a primary completion date of 2025-05-30.
⚠ 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
SCD and MCI are very heterogeneous conditions, which can be prodromal to different types of dementia. The application of data driven clustering methods on neuroimaging and inflammatory data aims at identifying the features characterizing subgroups of subjects at high risk of developing overt dementia. This approach promises to develop tailored early interventions for subjects with profiles of cognitive decline correlating with high risk of progression. To this end in this project, we propose to examine in these subjects both brain structure and cerebral blood flow (CBF) through MR T1-weighted and pCASL (pseudo-continuous arterial spin labeling) imaging and the neuroinflammatory status. The latter will be done by measuring the populations of innate and adaptive immune cells, the chemokines that are required to attract these cells to their potential sites of action in the CNS, and the cytokines by means they exert their function. The analyses performed in aged subjects with MCI and in SCD, will allow identifying common mechanisms predisposing to an increased susceptibility to progression to overt cognitive decline.
Eligibility Criteria
Inclusion Criteria: * age between 65 and 89 years; 5 years of schooling; * diagnosis of Mild Cognitive Impairment (Croisile et al., 2011) or * diagnosis of Subjective Cognitive Decline (Jessen et al., 2014). Exclusion Criteria: * neurological pathologies; dementia; * psychiatric disorders; * pathologies or orthopedic problems limiting participation to the aerobic physical training program and to the MR imaging.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06746909 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 89 Years, studying MCI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06746909 currently recruiting?
Yes, NCT06746909 is actively recruiting participants. Contact the research team at paolo.bosco@fsm.unipi.it for enrollment information.
Where is the NCT06746909 trial being conducted?
This trial is being conducted at Pisa, Italy.
Who is sponsoring the NCT06746909 clinical trial?
NCT06746909 is sponsored by IRCCS Fondazione Stella Maris. The trial plans to enroll 115 participants.