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

NCT06746909 | Recruiting

• 2 other identifiers: GR-2019-12370776"Age-It", PE00000015
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

MCI; SCD; Healthy

Outcome Measures

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.

  7 months

Secondary Outcomes (1)

• Sample stratification

  7, 14 and 28 months

Study Arms (6)

MCI training

ACTIVE COMPARATOR

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.

Other: Multidomain cognitive training and physical training

MCI no-training

NO INTERVENTION

Follow up of natural history of subjects after 7 months

healthy subjects

NO INTERVENTION

Follow up of natural history of subjects after 7 months

SCD

NO INTERVENTION

Follow up of natural history of subjects after 28 months

SCD training

ACTIVE COMPARATOR

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.

Other: Multidomain cognitive training and physical training

SCD no-training

NO INTERVENTION

Follow up of natural history of subjects after 7 months

Interventions

Multidomain cognitive training and physical training OTHER

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.

MCI training; SCD training

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• Humanitas Research Hospital IRCCS, Rozzano-Milan: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• Istituto di Neuroscienze Consiglio Nazionale delle Ricerche: collaborator

Study Sites (1)

Azienda Ospedaliera Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

Central Study Contacts

Paolo Bosco Bosco, PhD

CONTACT

+39 050886180; paolo.bosco@fsm.unipi.it

Michela Tosetti, MSc

CONTACT

michela.tosetti@fsm.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: February 1, 2022
• Primary Completion: May 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-11

Locations

IT (1)