Neurocognitive DisorderNCT03275363
The University of Hong Kong Neurocognitive Disorder Cohort
An observational study of Neurocognitive Disorder and Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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 more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Disorder, Mild Cognitive Impairment, Alzheimer Dementia
- What is being tested?
- Neurocognitive battery, MRI and Blood tests
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2014to 4 Jan 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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).
Who may be able to join
- Older adults with or without neurocognitive disoder. HKU NCD Cohort focuses primarily on people with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Medicine, Queen Mary Hospital, The University of Hong Kong
Hong Kong
Joseph SK Kwan, MD, +85222554769, jskkwan@hku.hk
Charlene Cheng, BA, +85222554769, cychar@hku.hk
About this study
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.
- Conditions
- Neurocognitive Disorder, Mild Cognitive Impairment, Alzheimer Dementia, Vascular Dementia, Age-related Cognitive Decline
- Being tested
- Neurocognitive battery, MRI, Blood tests, EEG with event-related potential (ERP), Amyloid PET CT
- Keywords
- Subjective cognitive decline, Mild Cognitive Impairment, Dementia, Cerebral aging
- Medical subject headings
- Neurocognitive Disorders, Cognitive Dysfunction, Alzheimer Disease, Dementia, Vascular, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurocognitive batteryDiagnostic test
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.
MRIDiagnostic test
MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients
Blood testsBiological
Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis
EEG with event-related potential (ERP)Diagnostic test
128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients
Amyloid PET CTDiagnostic test
F18 Flutametamol PET CT for selected patients
| Study group | Role | What they receive |
|---|---|---|
| Cognitively normal controls (CNC) | No subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Neurocognitive battery; Diagnostic Test: MRI; Biological: Blood tests; Diagnostic Test: Amyloid PET CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive decline
Change in total HK-MoCA score between baseline and follow-up
Measured: 1 year
Secondary outcomes (4)
Functional decline
Change in Lawton's IADL score between baseline and follow-up
Measured: 1 year
Neuropsychiatric decline
Change in Neuropsychiatric Index (NPI) between baseline and follow-up
Measured: 1 year
Quality of life decline
Change in QoL-AD score between baseline and follow-up
Measured: 1 year
Change in cognitive impairment status
Progression to mild cognitive impairment (MCI) or dementia status
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Sep 2014
- Primary completion1 Jan 2022 (estimated)
- Study completion4 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisorderStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Dementias Platform UK
- Responsible party
- Principal investigator, Dr Joseph SK Kwan, The University of Hong Kong
- Investigators
- Joseph SK Kwan, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275363
- Sponsor's protocol ID
- HKUNCDC
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Share with Dementias Platform UK (www.dementiasplatform.uk)
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University of Hong Kong Neurocognitive Disorder Cohort
- ClinicalTrials.gov ID
- NCT03275363
- Acronym / sponsor ID
- HKUNCDC
- Conditions
- Neurocognitive Disorder, Mild Cognitive Impairment, Alzheimer Dementia, Vascular Dementia, Age-related Cognitive Decline
- Keywords
- Subjective cognitive decline, Mild Cognitive Impairment, Dementia, Cerebral aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Dementias Platform UK
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 4 Jan 2022 (estimated)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cognitively normal controls (CNC) | – | Diagnostic Test: Neurocognitive battery, Diagnostic Test: MRI, Biological: Blood tests, Diagnostic Test: EEG with event-related potential (ERP)No subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described |
| Subjective cognitive decline (SCD) | – | Diagnostic Test: Neurocognitive battery, Diagnostic Test: MRI, Biological: Blood tests, Diagnostic Test: EEG with event-related potential (ERP), Diagnostic Test: Amyloid PET CTSubjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described |
| Mild cognitive impairment (MCI) | – | Diagnostic Test: Neurocognitive battery, Diagnostic Test: MRI, Biological: Blood tests, Diagnostic Test: EEG with event-related potential (ERP), Diagnostic Test: Amyloid PET CTSubjective memory complaints Low HK-MoCA Normal instrumental ADL All interventions as described |
| Alzheimer's dementia | – | Diagnostic Test: Neurocognitive battery, Diagnostic Test: MRI, Biological: Blood tests, Diagnostic Test: Amyloid PET CTSubjective memory complaints Low HK-MoCA Poor instrumental ADL Probable Alzheimer's disease All interventions as described except EEG with ERP |
| Vascular dementia | – | Diagnostic Test: Neurocognitive battery, Diagnostic Test: MRI, Biological: Blood tests, Diagnostic Test: Amyloid PET CTSubjective memory complaints Low HK-MoCA Poor instrumental ADL Related to stroke / cerebrovascular disease All interventions as described except EEG with ERP |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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).
Key inclusion criteria (1 listed)
- Older adults with or without neurocognitive disoder. HKU NCD Cohort focuses primarily on people with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurocognitive batteryCognitive 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 test | Alzheimer's dementia, Cognitively normal controls (CNC), Mild cognitive impairment (MCI), Subjective cognitive decline (SCD), Vascular dementia |
| MRIMRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients | Diagnostic test | Alzheimer's dementia, Cognitively normal controls (CNC), Mild cognitive impairment (MCI), Subjective cognitive decline (SCD), Vascular dementia |
| Blood testsStored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis | Biological | Alzheimer's dementia, Cognitively normal controls (CNC), Mild cognitive impairment (MCI), Subjective cognitive decline (SCD), Vascular dementia |
| EEG with event-related potential (ERP)128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients | Diagnostic test | Cognitively normal controls (CNC), Mild cognitive impairment (MCI), Subjective cognitive decline (SCD) |
| Amyloid PET CTF18 Flutametamol PET CT for selected patients | Diagnostic test | Alzheimer's dementia, Mild cognitive impairment (MCI), Subjective cognitive decline (SCD), Vascular dementia |
Primary outcome
Cognitive decline
Time frame: 1 year
Change in total HK-MoCA score between baseline and follow-up
4 secondary outcomes
Functional decline
Time frame: 1 year
Neuropsychiatric decline
Time frame: 1 year
Quality of life decline
Time frame: 1 year
Change in cognitive impairment status
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Individual participant dataSharing planned: Yes. Share with Dementias Platform UK (www.dementiasplatform.uk)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph SK Kwan, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorder and Mild Cognitive Impairment, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Sep 2017. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joseph SK Kwan, MD (+85222554769, jskkwan@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive decline (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2017.