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

NCT06572332 | Enrolling By Invitation

• 1 other identifier: 2023.171
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodegenerative Diseases; Aging; Brain; Cognitive Dysfunction

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Estimated brain age

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

  Baseline

• 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).

  Baseline

• Plasma β-amyloid

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

  Baseline

Secondary Outcomes (4)

• Brain-predicted age difference (brain-PAD)

  Baseline

• Complex attention

  Baseline

• Memory and learning

  Baseline

• Executive function

  Baseline

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ageing adults and adults with sleep disturbances.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Tai Po Hospital

Hong Kong, 100000, Hong Kong

Location

MeSH Terms

Conditions

Neurodegenerative Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hanna Lu, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 25, 2024
• First Posted: August 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Locations

HK (1)