A Global Approach to Tackle Cognitive Decline

Dementia Clinical Trial

Official title:

A Global Approach to Tackle Cognitive Decline

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05479318
• Other study ID #: 2022.119
• Status: Active, not recruiting
• Start date: September 1, 2022
• Est. completion date: October 1, 2025

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1502
• Est. completion date: October 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Dementia

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin	N.t.

Sponsors (7)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Max Planck Institute for Human Development, National University of Singapore, The University of New South Wales, Umeå University, University College, London, University of Oxford

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Record of any vascular risk factors	medical history of hypertension, diabetes mellitus, hyperlipidemia, smoking and drinking, record unit as yes or no	Baseline
Primary	Record of triglyceride level	triglyceride level, as one of vascular risk factors, unit as mmol/L	Baseline
Primary	Record of high-density-lipoprotein level,	high-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L	Baseline
Primary	Record of low-density-lipoprotein level,	low-density-lipoprotein level, as one of the vascular risk factors, unit as mmol/L	Baseline
Primary	Record of total cholesterol level,	total cholesterol level, as one of the vascular risk factors, unit as mmol/L	Baseline
Primary	Record of glycated hemoglobin	glycated hemoglobin, as one of the vascular risk factors, unit as percentage	Baseline
Primary	Record of fasting blood glucose	fasting blood glucose from blood results, as one of vascular risk factors, unit as mmol/L	Baseline
Primary	Record of blood pressure	Blood pressure, as one of vascular risk factors, unit as mmHg	Baseline
Primary	Record of pulse	Pulse rate, as one of vascular risk factors, unit as bpm	Baseline
Primary	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
Primary	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
Primary	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