NCT03275363

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2022

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

7.3 years

First QC Date

September 4, 2017

Last Update Submit

September 5, 2017

Conditions

Neurocognitive DisorderMild Cognitive ImpairmentAlzheimer DementiaVascular DementiaAge-related Cognitive Decline

Keywords

Subjective cognitive declineMild Cognitive ImpairmentDementiaCerebral aging

Outcome Measures

Primary Outcomes (1)

  • Cognitive decline

    Change in total HK-MoCA score between baseline and follow-up

    1 year

Secondary Outcomes (4)

  • Functional decline

    1 year

  • Neuropsychiatric decline

    1 year

  • Quality of life decline

    1 year

  • Change in cognitive impairment status

    1 year

Study Arms (5)

Cognitively normal controls (CNC)

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

Diagnostic Test: Neurocognitive batteryDiagnostic Test: MRIBiological: Blood testsDiagnostic Test: EEG with event-related potential (ERP)

Subjective cognitive decline (SCD)

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

Diagnostic Test: Neurocognitive batteryDiagnostic Test: MRIBiological: Blood testsDiagnostic 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

Diagnostic Test: Neurocognitive batteryDiagnostic Test: MRIBiological: Blood testsDiagnostic 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

Diagnostic Test: Neurocognitive batteryDiagnostic Test: MRIBiological: Blood testsDiagnostic 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

Diagnostic Test: Neurocognitive batteryDiagnostic Test: MRIBiological: Blood testsDiagnostic Test: Amyloid PET CT

Interventions

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.

Alzheimer's dementiaCognitively normal controls (CNC)Mild cognitive impairment (MCI)Subjective cognitive decline (SCD)Vascular dementia
MRIDIAGNOSTIC_TEST

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

Alzheimer's dementiaCognitively normal controls (CNC)Mild cognitive impairment (MCI)Subjective cognitive decline (SCD)Vascular dementia
Blood testsBIOLOGICAL

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

Alzheimer's dementiaCognitively normal controls (CNC)Mild cognitive impairment (MCI)Subjective cognitive decline (SCD)Vascular dementia
EEG with event-related potential (ERP)DIAGNOSTIC_TEST

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

Cognitively normal controls (CNC)Mild cognitive impairment (MCI)Subjective cognitive decline (SCD)
Amyloid PET CTDIAGNOSTIC_TEST

F18 Flutametamol PET CT for selected patients

Alzheimer's dementiaMild cognitive impairment (MCI)Subjective cognitive decline (SCD)Vascular dementia

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Older adults with or without neurocognitive disoder. HKU NCD Cohort focuses primarily on people with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hong Kong, Hong Kong

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood at baseline and at yearly follow up

MeSH Terms

Conditions

Neurocognitive DisordersCognitive DysfunctionAlzheimer DiseaseDementia, VascularDementia

Interventions

Hematologic TestsElectroencephalographyEvoked Potentials

Condition Hierarchy (Ancestors)

Mental DisordersCognition DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesDiagnostic Techniques, NeurologicalElectrodiagnosisCortical ExcitabilityElectrophysiological PhenomenaPhysiological PhenomenaNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Joseph SK Kwan, MD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph SK Kwan, MD

CONTACT

+85222554769jskkwan@hku.hk

Charlene Cheng, BA

CONTACT

+85222554769cychar@hku.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

September 4, 2017

First Posted

September 7, 2017

Study Start

September 1, 2014

Primary Completion

January 1, 2022

Study Completion

January 4, 2022

Last Updated

September 7, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

Share with Dementias Platform UK (www.dementiasplatform.uk)

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Due to be shared from 2017, indefinitely.
Access Criteria
Via Dementias Platform UK (www.dementiasplatform.uk)
More information

Locations

HK(1)