Actively Recruiting
Identification of Neuroinflammation and Neuroimaging Biomarkers Using AI Techniques in Older Adults at Risk of Dementia to Improve Prevention Strategies
Led by IRCCS Fondazione Stella Maris · Updated on 2024-12-24
115
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
I
IRCCS Fondazione Stella Maris
Lead Sponsor
H
Humanitas Research Hospital IRCCS, Rozzano-Milan
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the diversity of cognitive conditions known as Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI), which may lead to different types of dementia. The study uses advanced data analysis on brain imaging and inflammatory markers to identify groups of older adults at high risk of progressing to dementia. This approach hopes to develop personalized early interventions by understanding brain structure, blood flow, and immune cell activity related to cognitive decline. Participants include older adults diagnosed with MCI or SCD, along with healthy volunteers. The study divides participants into groups receiving either a 7-month multidomain training program or no training. The training involves supervised cognitive exercises, physical aerobic activity, and music therapy, scheduled as multiple weekly sessions. Brain scans using MR imaging and blood samples are collected at various times to assess brain structure, blood flow, and immune markers, with follow-ups extending up to 28 months. Throughout the study, participants undergo cognitive testing assessing memory, attention, and executive function at several time points. Brain imaging and blood tests are performed to monitor changes in brain volume, cerebral blood flow, and inflammation. The study compares outcomes between trained and untrained groups at 7, 14, and 28 months to evaluate short-term training effects and sample stratification. This comprehensive monitoring aims to identify biomarkers and patterns to better inform prevention strategies against dementia.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 65 and 89 years
- At least 5 years of schooling
- Diagnosis of Mild Cognitive Impairment (MCI) as defined by Croisile et al., 2011
- Diagnosis of Subjective Cognitive Decline (SCD) as defined by Jessen et al., 2014
You will not qualify if you...
- Presence of neurological diseases or dementia
- Presence of psychiatric disorders
- Physical or orthopedic problems that prevent participation in aerobic physical training or MR imaging
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 months
Participants in the training groups receive a 7 months-long multidomain training including cognitive sessions, physical exercise, and music therapy. Sessions are supervised and occur multiple times per week. Participants in the no-training groups are followed without intervention.
2 to 3 supervised sessions per week for 7 months
Duration - Up to 21 months after treatment
Participants are followed to assess cognitive integrity and inflammatory markers after the treatment period, with some assessments extending up to 28 months depending on group assignment.
Visits at 7, 14, and 28 months depending on participant group
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliera Universitaria Pisana
Pisa, Italy, 56126
Actively Recruiting
Research Team
P
Paolo Bosco Bosco, PhD
M
Michela Tosetti, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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