DementiaNCT05479318
A Global Approach to Tackle Cognitive Decline
An observational study of Dementia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 1,502 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2022to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be retrospectively selected from 7 cohorts from Hong Kong, Australia, Singapore and Europe areas.
Who may be able to join
- 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).
Who cannot join
- subjects with stroke, dementia, and other neurological diseases at baseline;
- those without longitudinal cognitive data;
- those without MRI data available.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dementia
- Medical subject headings
- Dementia
What is being measured
The primary outcome is the main question the study is designed to answer.
Record of any vascular risk factors
medical history of hypertension, diabetes mellitus, hyperlipidemia, smoking and drinking, record unit as yes or no
Measured: Baseline
Record of triglyceride level
triglyceride level, as one of vascular risk factors, unit as mmol/L
Measured: Baseline
Record of high-density-lipoprotein level,
high-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L
Measured: Baseline
Record of low-density-lipoprotein level,
low-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L
Measured: Baseline
Record of total cholesterol level,
total cholesterol level, as one of the vascular risk factors, unit as mmol/L
Measured: Baseline
Record of glycated hemoglobin
glycated hemoglobin, as one of the vascular risk factors, unit as percentage
Measured: Baseline
Record of fasting blood glucose
fasting blood glucose from blood results, as one of vascular risk factors, unit as mmol/L
Measured: Baseline
Record of blood pressure
Blood pressure, as one of vascular risk factors, unit as mmHg
Measured: Baseline
Record of pulse
Pulse rate, as one of vascular risk factors, unit as bpm
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline and 1 yr, 2yr and 3rd year follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Sep 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 1,502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales, University of Oxford, University College, London, Umeå University, Max Planck Institute for Human Development, National University of Singapore
- Responsible party
- Principal investigator, Bonnie Yin Ka LAM, Chinese University of Hong Kong
- Investigators
- Bonnie Yin Ka Lam, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479318
- Sponsor's protocol ID
- 2022.119
- Status last verified
- Feb 2024
- First submitted
- 18 May 2022
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Approach to Tackle Cognitive Decline
- ClinicalTrials.gov ID
- NCT05479318
- Acronym / sponsor ID
- 2022.119
- Conditions
- Dementia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,502 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- The University of New South Wales, University of Oxford, University College, London, Umeå University, Max Planck Institute for Human Development, National University of Singapore
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be retrospectively selected from 7 cohorts from Hong Kong, Australia, Singapore and Europe areas.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (3 listed)
- subjects with stroke, dementia, and other neurological diseases at baseline;
- those without longitudinal cognitive data;
- those without MRI data available.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Record of triglyceride level
Time frame: Baseline
triglyceride level, as one of vascular risk factors, unit as mmol/L
Record of high-density-lipoprotein level,
Time frame: Baseline
high-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L
Record of low-density-lipoprotein level,
Time frame: Baseline
low-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L
Record of total cholesterol level,
Time frame: Baseline
total cholesterol level, as one of the vascular risk factors, unit as mmol/L
Record of glycated hemoglobin
Time frame: Baseline
glycated hemoglobin, as one of the vascular risk factors, unit as percentage
Record of fasting blood glucose
Time frame: Baseline
fasting blood glucose from blood results, as one of vascular risk factors, unit as mmol/L
Record of blood pressure
Time frame: Baseline
Blood pressure, as one of vascular risk factors, unit as mmHg
Record of pulse
Time frame: Baseline
Pulse rate, as one of vascular risk factors, unit as bpm
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.
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bonnie Yin Ka Lam principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, 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 3 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. 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?
Results are not available in the source record.
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?
Record of any vascular risk factors (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Feb 2024.