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Status unknownNCT03275363Updated Sep 7, 2017

The University of Hong Kong Neurocognitive Disorder Cohort

An observational study in Neurocognitive Disorder, Mild Cognitive Impairment and Alzheimer Dementia, sponsored by The University of Hong Kong. Status unknown at 1 site in Hong Kong. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-07.

Sponsored by The University of Hong Kong · Observational

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
65 Years and older
Sex
All
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Study summary

The HKU Neurocognitive Disorder (NCD) Cohort is a hospital-based, prospective, observational study of older HK Chinese adults with cognitive impairment, with a special focus on studying patients with subjective cognitive decline and mild cognitive impairment.

Read the detailed description

The HKU Neurocognitive Disorder (NCD) Cohort is a hospital-based, prospective, observational study of older HK Chinese adults with cognitive impairment, with a special focus on studying patients with subjective cognitive decline and mild cognitive impairment, and in particular the biomarkers that predict cognitive and functional decline.

Comprehensive profiling of each subject is performed through a multi-domain assessment protocol including detailed demographics, lifestyle factors, neuropsychological battery, mood, MRI, genetics, blood biomarkers, and other patient-centred parameters including level of disability, quality of life and societal engagement. Ongoing annual follow up captures the essential clinical events and changes in neurocognitive function (conversion to MCI or dementia), mood, level of disability and quality of life; as well as repeat blood tests.

The HKU NCD Cohort is the first-ever Asian dementia cohort to be formally included into the Dementia Platforms UK, achieving an international collaborative status with other UK-based cohorts. The study neuropsychological battery is aligned with the NACC UDS3 battery.

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Conditions studied

  • Neurocognitive Disorder
  • Mild Cognitive Impairment
  • Alzheimer Dementia
  • Vascular Dementia
  • Age-related Cognitive Decline

Keywords

  • Subjective cognitive decline
  • Mild Cognitive Impairment
  • Dementia
  • Cerebral aging
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In context

Neurocognitive Disorders

274 studies on the registry are indexed under Neurocognitive Disorders; 90 are open to participants now.

This study's planned enrollment of 500 is above the median of 150 across 96 observational studies indexed under Neurocognitive Disorders.

Browse Neurocognitive Disorders studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,292 studies on the registry; 348 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

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Who can participate

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

Study population

Older adults with or without neurocognitive disoder. HKU NCD Cohort focuses primarily on people with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).

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

  • Older adults with or without neurocognitive disoder. HKU NCD Cohort focuses primarily on people with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).

Exclusion criteria

Exclusion Criteria:

  • Severe Parkinson's disease, major depressive disorder or severe psychiatric conditions, significant communication difficulties (e.g. aphasia, deafness), terminal cancer or likely end-of-life in the next 12 months.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cognitively normal controls (CNC)

    No subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described

    Diagnostic Test: Neurocognitive battery · Diagnostic Test: MRI · Biological: Blood tests · Diagnostic Test: EEG with event-related potential (ERP)

  • Subjective cognitive decline (SCD)

    Subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described

    Diagnostic Test: Neurocognitive battery · Diagnostic Test: MRI · Biological: Blood tests · Diagnostic Test: EEG with event-related potential (ERP) · Diagnostic Test: Amyloid PET CT

  • Mild cognitive impairment (MCI)

    Subjective memory complaints Low HK-MoCA Normal instrumental ADL All interventions as described

    Diagnostic Test: Neurocognitive battery · Diagnostic Test: MRI · Biological: Blood tests · Diagnostic Test: EEG with event-related potential (ERP) · Diagnostic Test: Amyloid PET CT

  • Alzheimer's dementia

    Subjective memory complaints Low HK-MoCA Poor instrumental ADL Probable Alzheimer's disease All interventions as described except EEG with ERP

    Diagnostic Test: Neurocognitive battery · Diagnostic Test: MRI · Biological: Blood tests · Diagnostic Test: Amyloid PET CT

  • Vascular dementia

    Subjective memory complaints Low HK-MoCA Poor instrumental ADL Related to stroke / cerebrovascular disease All interventions as described except EEG with ERP

    Diagnostic Test: Neurocognitive battery · Diagnostic Test: MRI · Biological: Blood tests · Diagnostic Test: Amyloid PET CT

Interventions

  • Diagnostic testNeurocognitive battery

    Cognitive impairment status (SCD, MCI, dementia), HK-MoCA, Clinical Dementia Rating (CDR sum of squares), Geriatric Depression Scale (GDS-15), Neuropsychiatric Index (NPI), Barthel Index, Lawton's IADL, Life-Space Assessment, Mini-Nutrition Assessment (MNA), Quality of Life for Alzheimer's Disease (QoL-AD, patient and carer parts), frailty status (FRAIL scale), handgrip strength, walking speed, exercise status, sleep quality, Charlson comorbidity index (CCI, age-adjusted). NACC: Story recall, Benson's complex figure copy, colour trail test (black \& white), verbal fluency, digit forward and backward span.

  • Diagnostic testMRI

    MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients

  • BiologicalBlood tests

    Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis

  • Diagnostic testEEG with event-related potential (ERP)

    128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients

  • Diagnostic testAmyloid PET CT

    F18 Flutametamol PET CT for selected patients

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What researchers measure

Primary outcomes

  1. Cognitive decline

    Change in total HK-MoCA score between baseline and follow-up

    Time frame: 1 year

Secondary outcomes

  1. Functional decline

    Change in Lawton's IADL score between baseline and follow-up

    Time frame: 1 year

  2. Neuropsychiatric decline

    Change in Neuropsychiatric Index (NPI) between baseline and follow-up

    Time frame: 1 year

  3. Quality of life decline

    Change in QoL-AD score between baseline and follow-up

    Time frame: 1 year

  4. Change in cognitive impairment status

    Progression to mild cognitive impairment (MCI) or dementia status

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • Department of Medicine, Queen Mary Hospital, The University of Hong Kong
    Hong Kong, Hong Kong
    Recruiting
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References and documents

Related links

Individual participant data

Plan to share: Yes — Share with Dementias Platform UK (www.dementiasplatform.uk)

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Due to be shared from 2017, indefinitely.

Access criteria: Via Dementias Platform UK (www.dementiasplatform.uk)

Data sharing details ↗ · www.dementiasplatform.uk

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2014 (actual). Primary completion is estimated for Jan 2022, 88 months after the start.

Of 52 non-industry observational studies under Neurocognitive Disorders, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 78. This study's planned 88 months is above that.

Counting every sponsor, half of 53 studies reached it within 44 months; a quarter within 20 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2017
First posted
Sep 7, 2017
StartActual
Sep 1, 2014
Primary completionEst.
Jan 1, 2022
CompletionEst.
Jan 4, 2022
Last update
Sep 7, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03275363
Collaborators
Dementias Platform UK
Responsible party
Dr Joseph SK Kwan (Clinical Associate Professor, The University of Hong Kong) — Principal investigator
First posted
Sep 7, 2017
Start date
Sep 1, 2014
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 4, 2022 (estimated)
Last update
Sep 7, 2017

Study contacts

Joseph SK Kwan, MD
Contact
jskkwan@hku.hk
+85222554769
Charlene Cheng, BA
Contact
cychar@hku.hk
+85222554769
Joseph SK Kwan, MD
principal investigator · The University of Hong Kong

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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