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

ConditionsMCISCDHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-89
SponsorIRCCS Fondazione Stella Maris

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

neurological pathologies; dementia;

psychiatric disorders;

pathologies or orthopedic problems limiting participation to the aerobic physical training program and to the MR imaging.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidomain cognitive training and physical training

    Other intervention

    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.

Treatment groups

115 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: MCI trainingActive comparator 1 intervention
Group B: MCI no-trainingNo intervention 0 interventions
Group C: healthy subjectsNo intervention 0 interventions
Group D: SCDNo intervention 0 interventions
Group E: SCD trainingActive comparator 1 intervention
Group F: SCD no-trainingNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Short term training effects

The MCI-training and MCI-no training, the SCD-training and SCD-no training groups will be compared at T7 in terms of cognitive performances, CBF, gray matter atrophy (both CBF and GM atrophy will be evaluated on different regions of interest) and inflammatory markers.

Time frame
7 months

Secondary outcomes

1

Sample stratification

clustering technique will be applied in order to identify homogeneous subgroups of anatomical, CBF, neuroinflammation patterns on both MCI and SCD cohort. The exploratory hypothesis is that different clusters at baseline may have different clinical outcomes at T7, T14 and T28. The outcome can also be modulated by the multi-domain intervention.

Time frame
7, 14 and 28 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Fondazione Stella Maris

Lead sponsor

Humanitas Research Hospital IRCCS, Rozzano-Milan

Collaborator

Azienda Ospedaliero, Universitaria Pisana

Collaborator

Istituto di Neuroscienze Consiglio Nazionale delle Ricerche

Collaborator