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Enrolling by invitation NCT06572332

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

Observational Neurodegenerative Diseases Aging Brain Cognitive Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neurodegenerative Diseases, Aging, Brain, Cognitive Dysfunction. Basic parameters: 50 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Estimated brain age [Time frame: Baseline]
  • Cognitive maintenance [Time frame: Baseline]
  • Plasma β-amyloid [Time frame: Baseline]
Secondary outcome measures (4)
  • Brain-predicted age difference (brain-PAD) [Time frame: Baseline]
  • Complex attention [Time frame: Baseline]
  • Memory and learning [Time frame: Baseline]
  • Executive function [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Hong Kong · 1 center
  • Tai Po Hospital — Hong Kong

Identifiers

NCT: NCT06572332 · 2023.171

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗