ClinicalTrials.gg
Not yet recruitingNCT07917182Updated Nov 4, 2026

Chinese University-Alzheimer's Disease With Vascular and Other Co-pathology: Towards Actionable Neuro-Cognitive-Omic Evaluations (CU-ADVANCE)

An observational study in Alzheimer s Disease and Mild Cognitive Impairment (MCI), sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in China. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Chinese University of Hong Kong · Observational

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1,600
Ages
40 Years and older
Sex
All
01

Study summary

Population aging is transforming the epidemiological landscape of the Asia-Pacific region at an unprecedented pace. By 2050, more than one quarter of the region's population will be aged over 60, with 36.7% of countries projected to become" super-aged" societies.

Within Hong Kong specifically, the age- and gender-adjusted prevalence rates of mild and major neurocognitive disorder (NCD) among adults aged 60 years or above have been estimated at 21.8% and 9.7%, respectively. The scale of this burden intensifies considerably within institutional care environments, where roughly seven in ten long-term care (LTC) residents have been identified as having major NCD. Recent local survey data also indicate that severe cognitive impairment affects up to 49.8% of residents aged above 85 years. Given current demographic trajectories, the number of individuals living with dementia in Hong Kong is projected to triple over the next two decades. These trends underscore an urgent, time-sensitive need for scalable, accurate, and population-appropriate tools for the early detection and prognostic stratification of cognitive impairment, tools that must be actionable at the point of care and deployable at population scale.

This study aim to generate a large database of cognitive, neuroimaging, plasma biomarkers, lifestyle and psychological information of the subjects who suffered from neurocognitive disorders

02

Conditions studied

  • Alzheimer s Disease
  • Mild Cognitive Impairment (MCI)
03

In context

Cognitive Dysfunction

3,941 studies on the registry are indexed under Cognitive Dysfunction; 1,117 are open to participants now.

This study's planned enrollment of 1,600 is above the median of 150 across 995 observational studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,453 studies on the registry; 474 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects will be identified from community, existing cohorts and specialist clinics

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged ≥ 40 years old; and
  2. Participants must have a study partner (spouse, relative, or other person in regular contact, ≥ 10 hours/week)who is willing and able to accompany participant to relevant visits and provide independent report on cognitive/functional/behavioral status (e.g., cognitive evaluation); and
  3. Visual and auditory acuity sufficient (with correction/hearing aids as needed) to complete neuropsychological testing as per examiner judgment; and
  4. A primary language of Cantonese.

Exclusion criteria

Exclusion Criteria:

  1. Clinical diagnosis of a primary neurological disorder that could independently account for cognitive impairment, including but not limited to Huntington's disease, normal pressure hydrocephalus, prion disease (CJD or variants), multiple sclerosis or other demyelinating disease, epilepsy, and/or
  2. Know history of major depressive episodes, schizophrenia, bipolar disorder, and/or
  3. Know history of moderate-to-severe traumatic brain injury, brain tumor, and/or
  4. Contraindication for MRI or PET.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1,600 participants (estimated)
Target follow-up
6 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • Cognitive Unimpaired
  • MCI

    Subject with mild cognitive impairment, which identified with CDR =0.5

  • Dementia

    Subject with mild cognitive impairment, which identified with CDR =1

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What researchers measure

Primary outcomes

  1. Hong Kong Montreal Cognitive Assessment (HK-MoCA)

    The HK-MoCA is a locally validated, brief cognitive screening tool assessing multiple domains including attention, executive function, memory, language, visuospatial ability, and orientation, and is widely used to detect mild cognitive impairment in the Hong Kong Chinese population. The total score is 30. The lower the score, the higher risk of cognitive impairment

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up

  2. Clinical Dementia Rating

    The CDR is a semi-structured interview-based staging instrument that evaluates both cognitive and functional performance across six domains (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care), yielding a global score that reflects overall severity of cognitive impairment (0 = normal, 0.5 = questionable/very mild, 1 = mild, 2 = moderate, 3 = severe).

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up

  3. Hong Kong List Learning Test

    The HKLLT is a culturally adapted verbal list-learning test modeled after the California Verbal Learning Test, used to assess verbal learning and memory, with Trial 4 (T4, delayed recall) serving as a sensitive index of episodic memory decline. The lower the standard deviation of the Trial 4 recall, the higher the risk of cognitive impairment

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up

  4. Simple Mild Neurocognitive Disorder due to Alzheimer's Disease Risk Test (SMART)

    The SMART is a novel digitalised tool that incorporates both subjective and objective measures of cognitive impairment. it incorporates immediate recall, delayed recall, and verbal fluency tasks. The lower the z-score, the higher the risk of cognitive impairment

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up

Secondary outcomes

  1. The pathological findings and changes on PET imaging

    An amyloid PET (Positron Emission Tomography) scan measures beta-amyloid plaques in the brain which lead to Alzheimer's disease (AD) pathogenesis. The key quantitative measurements are Standarized uptake value ratio (SUVR) and Centiloid Scale (CL) . The higher the vlaue of SUVR and CL reflect greater amyloid accumulation in the brain.

    Time frame: baseline and 3 year follow up

  2. The pathological findings and changes on MRI

    A MRI brain scan mainly investigate and measure the structure of the brain. Volume of specific brain regions (such as the hippocampus, ventricles, or total gray/white matter) in cubic centimeters (cm³)

    Time frame: baseline and 3 year follow up

Other outcomes

  1. Blood biomarkers

    Biomarkers will include molecular and cellular assays, genomic, epigenomic, and other multi-omic assays for both cellular and acellular fractions.

    Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up

07

Study locations

1 site
08

References and documents

Publications

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Individual participant data

Plan to share: Undecided

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07917182
Responsible party
Owen Ho KO (Professor, Chinese University of Hong Kong) — Principal investigator
First posted
Nov 4, 2026
Start date
Nov 30, 2026 (estimated)
Primary completion
Dec 31, 2031 (estimated)
Completion
Jun 30, 2032 (estimated)
Last update
Nov 4, 2026

Study contacts

Pauline Kwan, Master's Degree
Contact
paulinekwan@cuhk.edu.hk
+852 26352160

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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