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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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 89
Healthy Volunteers: t
View:

• 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).

Locations
Other Locations
Italy
Azienda Ospedaliera Universitaria Pisana
RECRUITING
Pisa
Contact Information
Primary
Paolo Bosco Bosco, PhD
paolo.bosco@fsm.unipi.it
+39 050886180
Backup
Michela Tosetti, MSc
michela.tosetti@fsm.unipi.it
Time Frame
Start Date: 2022-02-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 115
Treatments
Active_comparator: MCI training
After baseline assessment the MCI-training group will receive a 7 months-long multidomain training, including cognitive, physical exercise and music therapy; Enrolled subjects will be assigned to mixed-gender classes of maximum 10 subjects each and given 2 sessions of 60 minutes supervised cognitive training per day, 3 times a week, and one of 60 minutes supervised aerobic physical activity per day, 3 times a week for 7 months.
No_intervention: MCI no-training
Follow up of natural history of subjects after 7 months
No_intervention: healthy subjects
Follow up of natural history of subjects after 7 months
No_intervention: SCD
Follow up of natural history of subjects after 28 months
Active_comparator: SCD training
After baseline assessment the MCI-training group will receive a 7 months-long multidomain training, including cognitive, physical exercise and music therapy; Enrolled subjects will be assigned to mixed-gender classes of maximum 10 subjects each and given 2 sessions of 60 minutes supervised cognitive training per day, 3 times a week, and one of 60 minutes supervised aerobic physical activity per day, 3 times a week for 7 months.
No_intervention: SCD no-training
Follow up of natural history of subjects after 7 months
Related Therapeutic Areas
Sponsors
Collaborators: Humanitas Research Hospital IRCCS, Rozzano-Milan, Istituto di Neuroscienze Consiglio Nazionale delle Ricerche, Azienda Ospedaliero, Universitaria Pisana
Leads: IRCCS Fondazione Stella Maris

This content was sourced from clinicaltrials.gov