RecruitingNot ApplicableNCT06746909

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


Sponsor

IRCCS Fondazione Stella Maris

Enrollment

115 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 YearsMax Age: 89 Years

Inclusion Criteria3

  • 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 Criteria3

  • neurological pathologies; dementia;
  • psychiatric disorders;
  • pathologies or orthopedic problems limiting participation to the aerobic physical training program and to the MR imaging.

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Interventions

OTHERMultidomain cognitive training and physical training

The cognitive training programme will be based on 8 cycles composed by 18 sessions of exercises and activities aimed at stimulating multiple cognitive functions. Each cycle will last 3 weeks, after which the same kind of cognitive stimulation sessions will be restarted, with exercises and activities of increased complexity. Each cycle will be structured in sessions aimed at stimulating specific cognitive domains and in sessions focused on multimodal activities (music-therapy, cineforum, etc.). The physical training will include aerobic exercise on an ergometer cycle, whose duration will be increased gradually from 10 to 20 minutes followed by exercises targeted to improve muscle strength, physical function, neuromuscular control and flexibility.


Locations(1)

Azienda Ospedaliera Universitaria Pisana

Pisa, Italy

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NCT06746909


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