Actively Recruiting

Phase Not Applicable
Age: 65Years - 89Years
All Genders
Healthy Volunteers
ID06746909

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

Age: 65Years - 89Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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