The University of Hong Kong Neurocognitive Disorder Cohort

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment; Vascular Dementia; Alzheimer Dementia; Neurocognitive Disorder; Age-related Cognitive Decline
• Intervention / Treatment: Diagnostic test: Neurocognitive battery; Diagnostic test: MRI; Biological: Blood tests; Diagnostic test: EEG with event-related potential (ERP); Diagnostic test: Amyloid PET CT

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Medicine, Queen Mary Hospital, The University of Hong Kong
    • Contact: Joseph SK Kwan, MD; Phone Number: +85222554769; Email: jskkwan@hku.hk
    • Contact: Charlene Cheng, BA; Phone Number: +85222554769; Email: cychar@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

5

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Dementias Platform UK
• Investigators: Principal Investigator: Joseph SK Kwan, MD, The University of Hong Kong

Publications and helpful links

Helpful Links

• Profile of PI

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 4, 2022

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 5, 2017
• First Posted (Actual): September 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2017
• Last Update Submitted That Met QC Criteria: September 5, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Dementia; Subjective cognitive decline; Cerebral aging
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Alzheimer Disease; Cognitive Dysfunction; Dementia, Vascular; Neurocognitive Disorders
• Other Study ID Numbers: HKUNCDC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Share with Dementias Platform UK (www.dementiasplatform.uk)
• IPD Sharing Time Frame: Due to be shared from 2017, indefinitely.
• IPD Sharing Access Criteria: Via Dementias Platform UK (www.dementiasplatform.uk)
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No