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Not yet recruitingNCT07917182ClinicalTrials.gov record

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

Alzheimer s Disease · Mild Cognitive Impairment (MCI)

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Observational
Phase
Not applicable / not listed
Age range
40 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Accepted
Participants
1600 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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:

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.

Study population

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not reported
Masking
Not reported
Cognitive Unimpaired

Not reported in this registry record.

MCI

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

Dementia

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

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Hong Kong Montreal Cognitive Assessment (HK-MoCA)

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

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

Clinical Dementia Rating

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

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).

Hong Kong List Learning Test

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

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

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

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

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

Secondary measures

The pathological findings and changes in SUVR on PET imaging

Time frame: baseline and 3 year follow up

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

The pathological findings and changes on MRI

Time frame: baseline and 3 year follow up

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)

The pathological findings and changes in Centiloid Scale on PET imaging

Time frame: baseline and 3 year follow up

An amyloid PET (Positron Emission Tomography) scan measures beta-amyloid plaques in the brain which lead to Alzheimer's disease (AD) pathogenesis. Another key quantitative measurement is Centiloid Scale (CL) . The higher the value of CL reflect greater amyloid accumulation in the brain.

Other measures

Blood biomarkers

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

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

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

The Chinese University of Hong KongHong Kong, ChinaStatus unknown

Study team and timeline

Lead sponsor
Chinese University of Hong Kong
Study start
Nov 30, 2026 Estimated
Primary completion
Dec 31, 2031 Estimated
Study completion
Jun 30, 2032 Estimated
First posted
Nov 4, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Pauline Kwan, Master's DegreeCONTACTpaulinekwan@cuhk.edu.hk+852 26352160
Official study title

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

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026