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Enrolling by Invitation

NCT Number: NCT06572332

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

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.

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Key information

Conditions

Neurodegenerative Diseases Aging Brain Cognition Disorders Cognitive Dysfunction Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tai Po Hospital

Hong Kong, 100000

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Estimated brain age

    Time frame: Baseline

    Using the structural and functional connectivity, individual's brain age is calculated based on the connectivity features of core brain networks.

  2. Cognitive maintenance

    Time frame: Baseline

    The 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).

  3. Plasma β-amyloid

    Time frame: Baseline

    The levels of Aβ42 and Aβ40 in the plasma samples will be quantified by enzyme-linked immunosorbent assay.

Secondary outcomes

  1. Brain-predicted age difference (brain-PAD)

    Time frame: Baseline

    The brain-PAD score is computed as the difference between estimated brain age and chronological age (brain age minus chronological age).

  2. Complex attention

    Time frame: Baseline

    Attention network test (ANT) is an individually administered computerized task designed to evaluate three attentional components.

  3. Memory and learning

    Time frame: Baseline

    Word 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.

  4. Executive function

    Time frame: Baseline

    Executive function is measured by the category verbal fluency test (CVFT).

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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