A Global Approach to Tackle Cognitive Decline

February 13, 2024 updated by: Bonnie Yin Ka LAM, Chinese University of Hong Kong
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Participants will be retrospectively selected from a Hong Kong Chinese cohort, a Singaporean cohort, a British cohort, two European cohorts, and an Australian cohort.

Subjects from the above listed cohorts who fit the study criteria will be selected for this study.

Demographical information, clinical, vascular risk factors, MRI images and cognitive data will be retrieved from the cohorts.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1502

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • N.t.
      • Shatin, N.t., Hong Kong, 00000
        • Prince of Wales Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Record of any vascular risk factors
Time Frame: Baseline
medical history of hypertension, diabetes mellitus, hyperlipidemia, smoking and drinking, record unit as yes or no
Baseline
Record of triglyceride level
Time Frame: Baseline
triglyceride level, as one of vascular risk factors, unit as mmol/L
Baseline
Record of high-density-lipoprotein level,
Time Frame: Baseline
high-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L
Baseline
Record of low-density-lipoprotein level,
Time Frame: Baseline
low-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L
Baseline
Record of total cholesterol level,
Time Frame: Baseline
total cholesterol level, as one of the vascular risk factors, unit as mmol/L
Baseline
Record of glycated hemoglobin
Time Frame: Baseline
glycated hemoglobin, as one of the vascular risk factors, unit as percentage
Baseline
Record of fasting blood glucose
Time Frame: Baseline
fasting blood glucose from blood results, as one of vascular risk factors, unit as mmol/L
Baseline
Record of blood pressure
Time Frame: Baseline
Blood pressure, as one of vascular risk factors, unit as mmHg
Baseline
Record of pulse
Time Frame: Baseline
Pulse rate, as one of vascular risk factors, unit as bpm
Baseline
Change of Mini-Mental State Examination
Time Frame: Baseline and 3rd year follow up
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
Time Frame: Baseline, 1 yr, 2yr and 3rd year follow ups
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
Time Frame: Baseline and 1 yr, 2yr and 3rd year follow ups
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University College, London
University of Oxford
Umeå University
The University of New South Wales
Max Planck Institute for Human Development
National University of Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bonnie Yin Ka Lam, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022.119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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