The University of Hong Kong Neurocognitive Disorder Cohort

Mild Cognitive Impairment Clinical Trial

Official title:

The University of Hong Kong Neurocognitive Disorder Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03275363
• Other study ID #: HKUNCDC
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2017
• Last updated: September 5, 2017
• Start date: September 1, 2014
• Est. completion date: January 4, 2022

Study information

• Verified date: September 2017
• Source: The University of Hong Kong
• Contact: Joseph SK Kwan, MD
• Phone: +85222554769
• Email: jskkwan[@]hku.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 4, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Alzheimer Dementia
• Alzheimer Disease
• Cognition Disorders
• Dementia
• Dementia, Vascular
• Disease
• Mild Cognitive Impairment
• Neurocognitive Disorder
• Neurocognitive Disorders
• Vascular Dementia

Intervention

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.
• 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
• Amyloid PET CT
F18 Flutametamol PET CT for selected patients

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, Queen Mary Hospital, The University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Dementias Platform UK

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive decline	Change in total HK-MoCA score between baseline and follow-up	1 year
Secondary	Functional decline	Change in Lawton's IADL score between baseline and follow-up	1 year
Secondary	Neuropsychiatric decline	Change in Neuropsychiatric Index (NPI) between baseline and follow-up	1 year
Secondary	Quality of life decline	Change in QoL-AD score between baseline and follow-up	1 year
Secondary	Change in cognitive impairment status	Progression to mild cognitive impairment (MCI) or dementia status	1 year

External Links

•   Profile of PI