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Neurodegenerative DiseasesNCT06572332

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

An observational study of Neurodegenerative Diseases and Aging, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Neurodegenerative Diseases, Aging, Brain
How many people
300 participants
Where
1 siteHong Kong
Study dates
1 Jan 2025to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Ageing adults and adults with sleep disturbances.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hong Kong1 site

  • Tai Po Hospital

    Hong Kong, 100000

Other trials in Hong Kong

About this study

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

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.

Read the 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

Keywords
MRI, Brain age, Deep learning, Healthy longevity, Resilence, Cognitive maintenance, Simulation, Imaging phenotypes
Medical subject headings
Neurodegenerative Diseases, Cognitive Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimated brain age

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

    Measured: Baseline

  2. Cognitive maintenance

    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).

    Measured: Baseline

  3. Plasma β-amyloid

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

    Measured: Baseline

Secondary outcomes (4)

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

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

    Measured: Baseline

  2. Complex attention

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

    Measured: Baseline

  3. Memory and learning

    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.

    Measured: Baseline

  4. Executive function

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2024
  2. Study start1 Jan 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06572332
Sponsor's protocol ID
2023.171
Status last verified
Jan 2025
First submitted
25 Aug 2024
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neurodegenerative Diseases and Aging, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated brain age (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06572332.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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