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AD - Alzheimer's DiseaseNCT07347574

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

An observational study of AD - Alzheimer's Disease and Mild Cognitive Impairment, run by Hong Kong University of Science and Technology at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 75 yearsHealthy volunteers can take part
What is being tested?
Observational
How many people
2,500 participants
Where
1 siteChina
Study dates
23 Mar 2026to 30 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Community elderly dwellings

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nancy Ip, PhD contact

+852-23587304

boip@ust.hk

Kin Ying Mok, PhD contact

+852-23563164

mok@ust.hk

China1 site, 1 recruiting
  • Hong Kong University of Science and Technology

    Hong Kong

    Nancy Ip, PhD, +852-23587304, boip@ust.hk

    Kin Ying Mok, PhD, mok@ust.hk

    Recruiting

Other trials in China

About this study

Official title: NeuroCare Community Project: A Community Based Prospective Observational Study for Early Alzheimer's Detection in Hong Kong

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.

Read the detailed description

Introduction Population aging is a major global challenge with estimated 1.6 billion people will be over 65 by 2050. Aging is the main risk factor for many chronic diseases, including Alzheimer's disease (AD). Hong Kong features one of the world's largest proportions of older adults and highest life expectancy and therefore, Hong Kong will face a particular heavy burden on caring of elderly citizens with dementia. Hence, to better planning for caring the aging population within the community, there is a need for robust, community-based data integrating clinical, cognitive, biomarker, and neuroimaging metrics in ethnic Chinese populations. Research Objectives

  • Compare validity of clinical assessments, clinical diagnoses, and blood biomarker panels for identifying clinically normal, MCI, and AD using MRI scan and PET imaging as gold standard in a community-based setting.
  • Validate blood biomarker panels for predicting conversion from clinically normal to MCI-AD, AD, non-AD MCI/dementia, and MCI to AD/non-AD dementia.
  • Explore novel blood and imaging biomarkers for AD diagnosis and progression. Study Design Prospective, community-based cohort study lasting for 5-year duration and expected average 2-3 years longitudinal follow-up for participants.
  • Pre-screening of 6,000 community-dwelling elderly at community centers (5-min MoCA, no consent required).
  • Enrollment of ~2,500 participants for cross-sectional cohort with informed consent.
  • Participants selection and down select as detailed in next section. Participants will undergo clinical, cognitive, and functional assessments; demographic and clinical data collected at local centers.
  • Blood sampling by research personnel (HKUST, HKCeND, TWC) with fasting blood processed, analyzed, and stored at HKUST/HKCeND.
  • Proteomic results used to stratify participants into low, intermediate, or high risk; imaging follow-up based on stratification. Setting
  • Recruitment at district-level community centers for elderly across Hong Kong.
  • Centers act as support hubs for healthy aging and provide access to a representative sample.
  • Collaboration with Tung Wah College and Tung Wah Group of Hospitals' network. Participant Selection and Down-Selection via Multi-Stage Protocol
  • Target: Community-dwelling older adults (Han Chinese, age 60-75) identified through community centers.
  • Stage 1 - Brief cognitive screening: 6,000 screened via MoCA-5min; subgroup assignment by percentile (dementia: <2%, mild cognitive impairment (MCI): 2-16%, cognitively normal (CN): >16%).
  • Stage 2 - Cross-sectional cohort: 2,500 enrolled, informed consent, clinical and physical assessments, blood tests, clinical diagnosis (DSM-IV). Distribution of subgroups selected: dementia 14%, MCI 43%, and CN 43%.
  • Stage 3 - Proteomic sub-cohort: 750 selected for plasma proteomics (21- protein panel + pTau217) and stratified by proteomic score (negative < 21, intermediate 21-52, positive > 52).
  • Stage 4 - Imaging sub-cohort: 350 selected for advanced imaging (MRI, amyloid PET) based on clinical diagnosis and proteomic result. All assessments repeated at follow-up for longitudinal monitoring. Variables and Measurement
  • Brief Cognitive Function: MoCA-5min: Memory, attention, language, abstraction, orientation.
  • Demographics: Age, sex, ethnicity, marital status, family history, education, socio-economic status, occupation.
  • Anthropometrics: Height (stadiometer), weight (calibrated scale), BMI calculation.
  • Cardiovascular Health: BP, pulse (automated monitor).
  • Clinical Assessment Battery: MoCA (full), ADL, iADL, FRAIL, PHQ-9, MBIS.
  • Clinical Diagnosis: NIA-AA criteria, applied by registered physicians.
  • Blood Tests: 1) Chemistry: Liver, kidney, bone/muscle enzymes, lipids, glucose; 2) Haematology: CBC; 3) Proteomics: Olink, Simoa, Fujirebio, Alamar Biosciences platforms for plasma protein profiling; 4) Genomics (optional): Whole-genome sequencing, methylation arrays, RNA-seq for AD risk loci and gene expression.
  • Amyloid/Tau PET and MRI Brain Imaging: PET: Gold standard for amyloid/ tau detection; MRI for structural changes and regional volumetrics.
  • Imaging repeated at 2-3 years follow-up for longitudinal assessment.
Being tested
Observational
Keywords
Alzheimer's disease, PET imaging, MR imaging, Biomarker, Amyloid
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ObservationalOther

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

Study groups in NCT07347574
Study groupRoleWhat they receive
Cognitively normal (CN)Participants with normal cognition
Receives: Other: Observational
Mild cognitive impairment (MCI)Participants with MCI
Receives: Other: Observational
DementiaParticipants with dementia
Receives: Other: Observational

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 24 to 36 months after baseline

Secondary outcomes (3)
  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

    Measured: 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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study start23 Mar 2026
  3. Primary completion30 Dec 2030 (estimated)
  4. Study completion30 Dec 2030 (estimated)

Resources

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
Prospective
Enrolment
2,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07347574
Sponsor's protocol ID
HREP-2025-0390
Status last verified
Jan 2026
First submitted
9 Jan 2026
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34032364
  • 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.

    PubMed 38183344

Questions about this trial

What is this clinical trial studying?

An observational study of AD - Alzheimer's Disease and Mild Cognitive Impairment, run by Hong Kong University of Science and Technology at 1 site in China.

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 2 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nancy Ip, PhD (+852-23587304, boip@ust.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood biomarker (baseline) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07347574, which also lists 2 linked publications.

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 8 Jul 2026.

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