About this trial
Population aging is reshaping societal dynamics and presents significant global challenges. By 2050, it is projected that 1.6 billion people worldwide will be over the age of 65. Given that aging is the primary risk factor for many common chronic diseases, reducing the burden of age-related illnesses and promoting healthy aging have become critical public health priorities. Notably, Hong Kong has one of the largest proportions of elderly and the highest life expectancy in the world. Dementia, particularly Alzheimer's disease (AD), is a multifaceted condition influenced by both biological and behavioral factors. There is a paucity of robust, community-based prospective data in ethnic Chinese populations that integrate clinical and cognitive measures with objective biomarkers and neuroimaging, especially at earlier stages such as mild cognitive impairment (MCI) and early AD. This community-based project aims to establish a cohort of elderly in Hong Kong, with longitudinal follow-up for 2-3 years. A key strength of this research is the incorporation of a panel of blood biomarkers, which will provide a less invasive and more affordable screening tool to identify Alzheimer's disease at a much earlier stage in the community. Additionally, through benchmark with MRI and PET imaging gold standard, these biomarkers have the potential to predict the conversion risk 1) from clinically normal to mild cognitive impairment and Alzheimer's disease (AD dementia); 2) from clinically MCI to Alzheimer's disease (MCI-AD dementia) or remain static; and differentiate non-AD dementia from Alzheimer's disease (dementia-AD). Collectively, these data will facilitate monitoring of aging processes and cognitive decline, help to identify candidate modifiable factors associated with resilience, and generate a de-identified, Chinese-specific resource to advance healthy aging in Hong Kong.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Mentally capable of providing informed consent, with or without an informant present
Willing and able to undergo blood draw and complete study related assessments; willing to be contacted for follow-up
Disqualifiers
Lacks capacity to consent even with an informant present
Refuses or is unable to provide blood samples or complete essential assessments
Currently enrolled in another clinical trial that could interfere with this study
Known illness that prevents longitudinal follow up or uncontrolled medical illness such as neurodevelopmental disorder, neurodegenerative disease, epilepsy, central nervous system infection, neuroinflammatory diseases, brain tumor, cerebrovascular diseases, history of major psychiatric illness, history of major head injury with altered consciousness, sexually transmitted disease including HIV and syphilis, visual and auditory disability, history of alcohol dependence, substance use disorder, systemic autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis, or malignancy.
Trial population
Community elderly dwellings
Trial design
Cohort
Prospective
Treatments tested in this trial
Observational
Other interventionClinical profile, blood collection, cognitive assessment, MRI and PET imaging
Treatment groups
Trial outcomes
Primary outcomes
Blood biomarker (baseline)
Blood-based biomarkers provide a minimally invasive approach for detecting Alzheimer's disease-related pathology and for monitoring disease progression. Peripheral blood will be analyzed for a core panel that includes p tau217 and a multiplex 21 protein panel, with results generated under predefined quality control specifications.
Follow up blood biomarker
Proportion of longitudinally selected participants who complete the repeat fasting blood collection; report completion rate and reasons for non-completion.
Secondary outcomes
Change in MoCA from baseline to follow-up
Montreal Cognitive Assessment (MoCA), total score 0-30 (higher scores indicate better cognitive function; lower scores indicate worse function); mean change in MoCA total score is calculated based on the difference between MoCA scores at baseline and follow-up visits
Time to cognitive progression
Time from baseline to clinically adjudicated progression, defined as CN to MCI or dementia, or MCI to dementia, assessed over up to 36 months.
Multimodal imaging data collection
Proportion of invited imaging-subset participants who complete planned baseline MRI and amyloid/tau PET according to protocol; repeat completion rate reported at follow-up.
Sponsors and contacts
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Hong Kong University of Science and Technology
Lead sponsor
Hong Kong Center for Neurodegenerative Diseases
Collaborator
Tung Wah College
Collaborator