The University of Hong Kong Neurocognitive Disorder Cohort

NCT ID: NCT03275363

Last Updated: 2017-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-01

Study Completion Date

2022-01-04

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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cognitively normal controls (CNC)

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

Neurocognitive battery

Intervention Type DIAGNOSTIC_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.

MRI

Intervention Type DIAGNOSTIC_TEST

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

Blood tests

Intervention Type BIOLOGICAL

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

EEG with event-related potential (ERP)

Intervention Type DIAGNOSTIC_TEST

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

Subjective cognitive decline (SCD)

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

Neurocognitive battery

Intervention Type DIAGNOSTIC_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.

MRI

Intervention Type DIAGNOSTIC_TEST

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

Blood tests

Intervention Type BIOLOGICAL

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

EEG with event-related potential (ERP)

Intervention Type DIAGNOSTIC_TEST

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

Amyloid PET CT

Intervention Type DIAGNOSTIC_TEST

F18 Flutametamol PET CT for selected patients

Mild cognitive impairment (MCI)

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

Neurocognitive battery

Intervention Type DIAGNOSTIC_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.

MRI

Intervention Type DIAGNOSTIC_TEST

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

Blood tests

Intervention Type BIOLOGICAL

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

EEG with event-related potential (ERP)

Intervention Type DIAGNOSTIC_TEST

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

Amyloid PET CT

Intervention Type DIAGNOSTIC_TEST

F18 Flutametamol PET CT for selected patients

Alzheimer's dementia

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

Neurocognitive battery

Intervention Type DIAGNOSTIC_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.

MRI

Intervention Type DIAGNOSTIC_TEST

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

Blood tests

Intervention Type BIOLOGICAL

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

Amyloid PET CT

Intervention Type DIAGNOSTIC_TEST

F18 Flutametamol PET CT for selected patients

Vascular dementia

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

Neurocognitive battery

Intervention Type DIAGNOSTIC_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.

MRI

Intervention Type DIAGNOSTIC_TEST

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

Blood tests

Intervention Type BIOLOGICAL

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

Amyloid PET CT

Intervention Type DIAGNOSTIC_TEST

F18 Flutametamol PET CT for selected patients

Interventions

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Neurocognitive 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.

Intervention Type DIAGNOSTIC_TEST

MRI

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

Intervention Type DIAGNOSTIC_TEST

Blood tests

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

Intervention Type BIOLOGICAL

EEG with event-related potential (ERP)

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

Intervention Type DIAGNOSTIC_TEST

Amyloid PET CT

F18 Flutametamol PET CT for selected patients

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dementias Platform UK

UNKNOWN

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr Joseph SK Kwan

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joseph SK Kwan, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

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Department of Medicine, Queen Mary Hospital, The University of Hong Kong

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Joseph SK Kwan, MD

Role: CONTACT

+85222554769

Charlene Cheng, BA

Role: CONTACT

+85222554769

Facility Contacts

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Joseph SK Kwan, MD

Role: primary

+85222554769

Charlene Cheng, BA

Role: backup

+85222554769

Related Links

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Other Identifiers

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HKUNCDC

Identifier Type: -

Identifier Source: org_study_id

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