NCT07347574

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026Dec 2030

First Submitted

Initial submission to the registry

January 9, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

4.9 years

First QC Date

January 9, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

Alzheimer's diseasePET imagingMR imagingBiomarkerAmyloid

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline

  • Follow up blood biomarker

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

    24 to 36 months after baseline

Secondary Outcomes (3)

  • Change in MoCA from baseline to follow-up

    Baseline to approximately 24-36 months

  • Time to cognitive progression

    Baseline to approximately 24-36 months

  • Multimodal imaging data collection

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

Study Arms (3)

Cognitively normal (CN)

Participants with normal cognition

Other: Observational

Mild cognitive impairment (MCI)

Participants with MCI

Other: Observational

Dementia

Participants with dementia

Other: Observational

Interventions

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

Cognitively normal (CN)DementiaMild cognitive impairment (MCI)

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community elderly dwellings

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Active delirium or evidence of reversible/secondary causes of cognitive impairment (e.g., vitamin B12 deficiency, hypothyroidism) until treated/ stabilized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong University of Science and Technology

Hong Kong, China

Location

Related Publications (2)

  • Jiang Y, Zhou X, Ip FC, Chan P, Chen Y, Lai NCH, Cheung K, Lo RMN, Tong EPS, Wong BWY, Chan ALT, Mok VCT, Kwok TCY, Mok KY, Hardy J, Zetterberg H, Fu AKY, Ip NY. Large-scale plasma proteomic profiling identifies a high-performance biomarker panel for Alzheimer's disease screening and staging. Alzheimers Dement. 2022 Jan;18(1):88-102. doi: 10.1002/alz.12369. Epub 2021 May 25.

    PMID: 34032364BACKGROUND
  • Jiang Y, Uhm H, Ip FC, Ouyang L, Lo RMN, Cheng EYL, Cao X, Tan CMC, Law BCH, Ortiz-Romero P, Puig-Pijoan A, Fernandez-Lebrero A, Contador J, Mok KY, Hardy J, Kwok TCY, Mok VCT, Suarez-Calvet M, Zetterberg H, Fu AKY, Ip NY. A blood-based multi-pathway biomarker assay for early detection and staging of Alzheimer's disease across ethnic groups. Alzheimers Dement. 2024 Mar;20(3):2000-2015. doi: 10.1002/alz.13676. Epub 2024 Jan 6.

    PMID: 38183344BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDementia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Nancy Ip, PhD

    Hong Kong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Ip, PhD

CONTACT

Kin Ying Mok, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 16, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 30, 2030

Study Completion (Estimated)

December 30, 2030

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations