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Simulation-informed Modelling and Personalized Evaluation (SIMPLE) in Ageing Populations

Simulation-informed Modelling and Personalized Evaluation (SIMPLE): A Computational Study of MRI-based Brain Age Matrices

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06572332
Enrollment
300
Registered
2024-08-27
Start date
2025-01-01
Completion date
2026-12-31
Last updated
2025-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Brain, Cognitive Dysfunction, Neurodegenerative Diseases

Keywords

MRI, Brain age, Deep learning, Healthy longevity, Resilence, Cognitive maintenance, Simulation, Imaging phenotypes

Brief summary

Multimodal magnetic resonance imaging (MRI), detecting brain structural and functional changes, has emerged as a powerful and promising technique to study individual's brain, as T1-weighted scans can detect morphometric features, diffusion tensor imaging (DTI) scans can quantify structural connectivity, and functional MRI can capture the features of functional connectivity. Notably, with the advances in quantitative methods, computational models of brain age and brain-predicted age difference (brain-PAD) detecting the ageing effects on individual's brain features are becoming increasingly popular in clinical studies, which might revolutionize the diagnostic and prognostic phonotypes of age-related brain diseases globally.

Detailed description

The score of brain-PAD has threefold explanations: a. negative score representing decelerated brain ageing (brain age\<chronological age); b. positive score representing accelerated brain ageing (brain age\>chronological age); c. score equal to zero, representing normal brain ageing (brain age=chronological age). The score of brain-PAD indicates the brain ageing pattern with the interaction of lifestyle and cognitive status at individual level. For example, based on structural MRI scans, a younger brain age or a negative score of brain-PAD was found to be associated with better cognition, which indicates the potential utilities of brain age matrices in predicting individual's cognitive maintenance and healthy longevity

Interventions

None listed

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

* Chinese old adults are the ones who are over 60 years of chronological age. * Sleep disturbance: individual's subjective sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI) with a total score \>5.

Exclusion criteria

* History of bipolar disorders or psychosis. * History of major neurological deficits, including stroke, transient ischemic attack or brain tumor. * Unable to participant magnetic resonance imaging (MRI) scanning.

Design outcomes

Primary

MeasureTime frameDescription
Estimated brain ageBaselineUsing the structural and functional connectivity, individual's brain age is calculated based on the connectivity features of core brain networks.
Cognitive maintenanceBaselineThe dynamic change of cognitive status is used to evaluate cognitive maintenance. The performance of global cognition is used to determine the cognitive status, including mild neurocognitive disorder (NCD) and major NCD. The global cognition is measured by mini-mental state examination (MMSE).
Plasma β-amyloidBaselineThe levels of Aβ42 and Aβ40 in the plasma samples will be quantified by enzyme-linked immunosorbent assay.

Secondary

MeasureTime frameDescription
Brain-predicted age difference (brain-PAD)BaselineThe brain-PAD score is computed as the difference between estimated brain age and chronological age (brain age minus chronological age).
Executive functionBaselineExecutive function is measured by the category verbal fluency test (CVFT).
Complex attentionBaselineAttention network test (ANT) is an individually administered computerized task designed to evaluate three attentional components.
Memory and learningBaselineWord list learning test consisting of fifteen semantically non-associated words that is presented consecutively over three trials of immediate recall and a 20-min delayed recall.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026