The University of Hong Kong Neurocognitive Disorder Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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The University of Hong Kong Neurocognitive Disorder Cohort

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

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


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cognitively normal controls (CNC)<br>No subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described | Diagnostic Test: Neurocognitive battery<br>* 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.<br>Diagnostic Test: MRI<br>* MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients<br>Biological: Blood tests<br>* Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis<br>Diagnostic Test: EEG with event-related potential (ERP)<br>* 128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients<br>|
| Subjective cognitive decline (SCD)<br>Subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described | Diagnostic Test: Neurocognitive battery<br>* 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.<br>Diagnostic Test: MRI<br>* MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients<br>Biological: Blood tests<br>* Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis<br>Diagnostic Test: EEG with event-related potential (ERP)<br>* 128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients<br>Diagnostic Test: Amyloid PET CT<br>* F18 Flutametamol PET CT for selected patients<br>|
| Mild cognitive impairment (MCI)<br>Subjective memory complaints Low HK-MoCA Normal instrumental ADL All interventions as described | Diagnostic Test: Neurocognitive battery<br>* 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.<br>Diagnostic Test: MRI<br>* MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients<br>Biological: Blood tests<br>* Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis<br>Diagnostic Test: EEG with event-related potential (ERP)<br>* 128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients<br>Diagnostic Test: Amyloid PET CT<br>* F18 Flutametamol PET CT for selected patients<br>|
| Alzheimer's dementia<br>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<br>* 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.<br>Diagnostic Test: MRI<br>* MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients<br>Biological: Blood tests<br>* Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis<br>Diagnostic Test: Amyloid PET CT<br>* F18 Flutametamol PET CT for selected patients<br>|
| Vascular dementia<br>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<br>* 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.<br>Diagnostic Test: MRI<br>* MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients<br>Biological: Blood tests<br>* Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis<br>Diagnostic Test: Amyloid PET CT<br>* F18 Flutametamol PET CT for selected patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive decline | Change in total HK-MoCA score between baseline and follow-up | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional decline | Change in Lawton's IADL score between baseline and follow-up | 1 year | 
| Neuropsychiatric decline | Change in Neuropsychiatric Index (NPI) between baseline and follow-up | 1 year | 
| Quality of life decline | Change in QoL-AD score between baseline and follow-up | 1 year | 
| Change in cognitive impairment status | Progression to mild cognitive impairment (MCI) or dementia status | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subjective cognitive decline, Mild Cognitive Impairment, Dementia, Cerebral aging