NCT05479318

Brief Summary

The number of people suffering from dementia in Asia (22.9 million) is more than twice the numbers in Europe (10.5 million) or the Americas (9.4 million), as recorded in the global impact of dementia in the World Alzheimer Report 2015.1 This dementia tsunami will continue to rise and the estimated number is 67 million in 2050 in Asia alone, which will be 2 to 3 times higher than the estimates for Europe (19 million) or the Americas (30 million). Devising and implementing preventive strategies against dementia is of paramount importance. The proposed project will be able to establish the associations between VRFs and cognition across cohorts with cultural, ethnical, and demographical variations. This study will generate data for evidence-based knowledge for globally implementable and effective preventive strategies for cognitive impairment and dementia.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,502

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2.7 years

First QC Date

May 18, 2022

Last Update Submit

February 13, 2024

Conditions

Outcome Measures

Primary Outcomes (12)

  • Record of any vascular risk factors

    medical history of hypertension, diabetes mellitus, hyperlipidemia, smoking and drinking, record unit as yes or no

    Baseline

  • Record of triglyceride level

    triglyceride level, as one of vascular risk factors, unit as mmol/L

    Baseline

  • Record of high-density-lipoprotein level,

    high-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L

    Baseline

  • Record of low-density-lipoprotein level,

    low-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L

    Baseline

  • Record of total cholesterol level,

    total cholesterol level, as one of the vascular risk factors, unit as mmol/L

    Baseline

  • Record of glycated hemoglobin

    glycated hemoglobin, as one of the vascular risk factors, unit as percentage

    Baseline

  • Record of fasting blood glucose

    fasting blood glucose from blood results, as one of vascular risk factors, unit as mmol/L

    Baseline

  • Record of blood pressure

    Blood pressure, as one of vascular risk factors, unit as mmHg

    Baseline

  • Record of pulse

    Pulse rate, as one of vascular risk factors, unit as bpm

    Baseline

  • Change of Mini-Mental State Examination

    Mini-Mental State Examination is used for measuring general cognition including the domains of attention and processing speed, executive function, memory, visuospatial function, and animal fluency.

    Baseline and 3rd year follow up

  • Change of Montreal Cognitive Assessment

    Montreal Cognitive Assessment is used for measuring general cognition including the domains of attention and processing speed, executive function, memory, visuospatial function, and animal fluency.

    Baseline, 1 yr, 2yr and 3rd year follow ups

  • Changes of brain white matter abnormalities

    brain white matter abnormalities can be observed through the FLAIR sequence of brain MRI images

    Baseline and 1 yr, 2yr and 3rd year follow ups

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be retrospectively selected from 7 cohorts from Hong Kong, Australia, Singapore and Europe areas.

You may qualify if:

  • Elderly community-dwelling individuals aged over 60 years old;
  • those with at least 2 time points of detailed cognitive measurements, with 2-3 years of assessment interval;
  • with at least 1 timepoint of MRI (T1, FLAIR, and DTI).

You may not qualify if:

  • subjects with stroke, dementia, and other neurological diseases at baseline;
  • those without longitudinal cognitive data;
  • those without MRI data available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, N.T., 00000, Hong Kong

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Bonnie Yin Ka Lam

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

May 18, 2022

First Posted

July 29, 2022

Study Start

September 1, 2022

Primary Completion

May 1, 2025

Study Completion

October 1, 2025

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations