NeuroCare Community Project: A Community Based Prospective Observational Study for Early Alzheimer's Detection in HK

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-75
SponsorHong Kong University of Science and Technology

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    Clinical profile, blood collection, cognitive assessment, MRI and PET imaging

Treatment groups

2,500 Participants
are divided into 3 treatment groups
Group A: Cognitively normal (CN)1 intervention
Group B: Mild cognitive impairment (MCI)1 intervention
Group C: Dementia1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

Follow up blood biomarker

Proportion of longitudinally selected participants who complete the repeat fasting blood collection; report completion rate and reasons for non-completion.

Time frame
24 to 36 months after baseline

Secondary outcomes

1

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 frame
Baseline to approximately 24-36 months
2

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.

Time frame
Baseline to approximately 24-36 months
3

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.

Time frame
Baseline (PET/MRI within 3-6 months of baseline blood) and repeat at approximately 24-36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hong Kong University of Science and Technology

Lead sponsor

Hong Kong Center for Neurodegenerative Diseases

Collaborator

Tung Wah College

Collaborator