Actively Recruiting
Identification of Neuroinflammation and Neuroimaging Biomarkers Using Artificial Intelligence to Understand Dementia Risk in Older Adults and Improve Prevention A Study of Multidomain Training Effects in Mild Cognitive Impairment and Subjective Cognitive Decline
Led by IRCCS Fondazione Stella Maris · Updated on 2024-12-24
115
Participants Needed
1
Research Sites
230 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
This research aims to identify neuroinflammation and neuroimaging biomarkers in older adults aged 65 to 89 years at risk of dementia, including those with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD). By applying advanced data-driven artificial intelligence clustering techniques to brain imaging and inflammatory data, the study seeks to better understand the heterogeneity of cognitive decline and to develop personalized early interventions for subjects with high risk of progression to dementia. Participants include 35 MCI individuals in a training group, 35 MCI individuals in a placebo group, and 75 SCD subjects. The intervention involves a 7-month multidomain training program combining cognitive exercises, physical aerobic training, and music therapy. Cognitive training consists of 8 cycles of 18 sessions, focusing on multiple cognitive functions and increasing in complexity. Physical training includes aerobic exercise on a cycle ergometer with gradually increasing duration, followed by strength and flexibility exercises. Some participants will receive training while others will be observed in their natural history. Throughout the study, cognitive assessments will be conducted at multiple time points up to 28 months depending on the group. Brain MRI scans assessing structure and cerebral blood flow (CBF) will be performed at baseline and follow-up visits. Blood samples will be collected to analyze immune cell populations and inflammatory markers. Outcomes measured include cognitive performance, brain imaging changes, and inflammatory markers. The study also includes data analysis using clustering methods to identify subgroups and patterns related to cognitive decline and risk of dementia.
CONDITIONS
Official 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 with at least 5 years of schooling
- Diagnosis of Mild Cognitive Impairment (MCI)
- Diagnosis of Subjective Cognitive Decline (SCD)
You will not qualify if you...
- Presence of neurological diseases or dementia
- Presence of psychiatric disorders
- Health or orthopedic problems that limit participation in aerobic physical training or MRI scans
AI-Screening
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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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