<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03275363</url>
  </required_header>
  <id_info>
    <org_study_id>HKUNCDC</org_study_id>
    <nct_id>NCT03275363</nct_id>
  </id_info>
  <brief_title>The University of Hong Kong Neurocognitive Disorder Cohort</brief_title>
  <official_title>The University of Hong Kong Neurocognitive Disorder Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dementias Platform UK</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The HKU Neurocognitive Disorder (NCD) Cohort is a hospital-based, prospective, observational&#xD;
      study of older HK Chinese adults with cognitive impairment, with a special focus on studying&#xD;
      patients with subjective cognitive decline and mild cognitive impairment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HKU Neurocognitive Disorder (NCD) Cohort is a hospital-based, prospective, observational&#xD;
      study of older HK Chinese adults with cognitive impairment, with a special focus on studying&#xD;
      patients with subjective cognitive decline and mild cognitive impairment, and in particular&#xD;
      the biomarkers that predict cognitive and functional decline.&#xD;
&#xD;
      Comprehensive profiling of each subject is performed through a multi-domain assessment&#xD;
      protocol including detailed demographics, lifestyle factors, neuropsychological battery,&#xD;
      mood, MRI, genetics, blood biomarkers, and other patient-centred parameters including level&#xD;
      of disability, quality of life and societal engagement. Ongoing annual follow up captures the&#xD;
      essential clinical events and changes in neurocognitive function (conversion to MCI or&#xD;
      dementia), mood, level of disability and quality of life; as well as repeat blood tests.&#xD;
&#xD;
      The HKU NCD Cohort is the first-ever Asian dementia cohort to be formally included into the&#xD;
      Dementia Platforms UK, achieving an international collaborative status with other UK-based&#xD;
      cohorts. The study neuropsychological battery is aligned with the NACC UDS3 battery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Anticipated">January 4, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>Cognitive decline</measure>
    <time_frame>1 year</time_frame>
    <description>Change in total HK-MoCA score between baseline and follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional decline</measure>
    <time_frame>1 year</time_frame>
    <description>Change in Lawton's IADL score between baseline and follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychiatric decline</measure>
    <time_frame>1 year</time_frame>
    <description>Change in Neuropsychiatric Index (NPI) between baseline and follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life decline</measure>
    <time_frame>1 year</time_frame>
    <description>Change in QoL-AD score between baseline and follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive impairment status</measure>
    <time_frame>1 year</time_frame>
    <description>Progression to mild cognitive impairment (MCI) or dementia status</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Neurocognitive Disorder</condition>
  <condition>Mild Cognitive Impairment</condition>
  <condition>Alzheimer Dementia</condition>
  <condition>Vascular Dementia</condition>
  <condition>Age-related Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>Cognitively normal controls (CNC)</arm_group_label>
    <description>No subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjective cognitive decline (SCD)</arm_group_label>
    <description>Subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <description>Subjective memory complaints Low HK-MoCA Normal instrumental ADL All interventions as described</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alzheimer's dementia</arm_group_label>
    <description>Subjective memory complaints Low HK-MoCA Poor instrumental ADL Probable Alzheimer's disease All interventions as described except EEG with ERP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vascular dementia</arm_group_label>
    <description>Subjective memory complaints Low HK-MoCA Poor instrumental ADL Related to stroke / cerebrovascular disease All interventions as described except EEG with ERP</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Neurocognitive battery</intervention_name>
    <description>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).&#xD;
NACC: Story recall, Benson's complex figure copy, colour trail test (black &amp; white), verbal fluency, digit forward and backward span.</description>
    <arm_group_label>Alzheimer's dementia</arm_group_label>
    <arm_group_label>Cognitively normal controls (CNC)</arm_group_label>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <arm_group_label>Subjective cognitive decline (SCD)</arm_group_label>
    <arm_group_label>Vascular dementia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients</description>
    <arm_group_label>Alzheimer's dementia</arm_group_label>
    <arm_group_label>Cognitively normal controls (CNC)</arm_group_label>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <arm_group_label>Subjective cognitive decline (SCD)</arm_group_label>
    <arm_group_label>Vascular dementia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood tests</intervention_name>
    <description>Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis</description>
    <arm_group_label>Alzheimer's dementia</arm_group_label>
    <arm_group_label>Cognitively normal controls (CNC)</arm_group_label>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <arm_group_label>Subjective cognitive decline (SCD)</arm_group_label>
    <arm_group_label>Vascular dementia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>EEG with event-related potential (ERP)</intervention_name>
    <description>128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients</description>
    <arm_group_label>Cognitively normal controls (CNC)</arm_group_label>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <arm_group_label>Subjective cognitive decline (SCD)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Amyloid PET CT</intervention_name>
    <description>F18 Flutametamol PET CT for selected patients</description>
    <arm_group_label>Alzheimer's dementia</arm_group_label>
    <arm_group_label>Mild cognitive impairment (MCI)</arm_group_label>
    <arm_group_label>Subjective cognitive decline (SCD)</arm_group_label>
    <arm_group_label>Vascular dementia</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Venous blood at baseline and at yearly follow up&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Older adults with or without neurocognitive disoder. HKU NCD Cohort focuses primarily on&#xD;
        people with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older adults with or without neurocognitive disoder. HKU NCD Cohort focuses primarily&#xD;
             on people with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe Parkinson's disease, major depressive disorder or severe psychiatric&#xD;
             conditions, significant communication difficulties (e.g. aphasia, deafness), terminal&#xD;
             cancer or likely end-of-life in the next 12 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph SK Kwan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Joseph SK Kwan, MD</last_name>
    <phone>+85222554769</phone>
    <email>jskkwan@hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Charlene Cheng, BA</last_name>
    <phone>+85222554769</phone>
    <email>cychar@hku.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Medicine, Queen Mary Hospital, The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph SK Kwan, MD</last_name>
      <phone>+85222554769</phone>
      <email>jskkwan@hku.hk</email>
    </contact>
    <contact_backup>
      <last_name>Charlene Cheng, BA</last_name>
      <phone>+85222554769</phone>
      <email>cychar@hku.hk</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <link>
    <url>http://hub.hku.hk/cris/rp/rp01868</url>
    <description>Profile of PI</description>
  </link>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr Joseph SK Kwan</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Subjective cognitive decline</keyword>
  <keyword>Mild Cognitive Impairment</keyword>
  <keyword>Dementia</keyword>
  <keyword>Cerebral aging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia, Vascular</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
    <mesh_term>Neurocognitive Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Share with Dementias Platform UK (www.dementiasplatform.uk)</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Due to be shared from 2017, indefinitely.</ipd_time_frame>
    <ipd_access_criteria>Via Dementias Platform UK (www.dementiasplatform.uk)</ipd_access_criteria>
    <ipd_url>http://www.dementiasplatform.uk</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03275363
org study id: HKUNCDC
nct id: NCT03275363
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Cognitive decline
time frame: 1 year
description: Change in total HK-MoCA score between baseline and follow-up
measure: Functional decline
time frame: 1 year
description: Change in Lawton's IADL score between baseline and follow-up
measure: Neuropsychiatric decline
time frame: 1 year
description: Change in Neuropsychiatric Index (NPI) between baseline and follow-up
measure: Quality of life decline
time frame: 1 year
description: Change in QoL-AD score between baseline and follow-up
measure: Change in cognitive impairment status
time frame: 1 year
description: Progression to mild cognitive impairment (MCI) or dementia status
arm group label: Cognitively normal controls (CNC)
description: No subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described
arm group label: Subjective cognitive decline (SCD)
description: Subjective memory complaints Normal HK-MoCA Normal instrumental ADL All interventions as described
arm group label: Mild cognitive impairment (MCI)
description: Subjective memory complaints Low HK-MoCA Normal instrumental ADL All interventions as described
arm group label: Alzheimer's dementia
description: Subjective memory complaints Low HK-MoCA Poor instrumental ADL Probable Alzheimer's disease All interventions as described except EEG with ERP
arm group label: Vascular dementia
description: Subjective memory complaints Low HK-MoCA Poor instrumental ADL Related to stroke / cerebrovascular disease All interventions as described except EEG with ERP
intervention type: Diagnostic Test
intervention name: Neurocognitive battery
description: 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.
arm group label: Alzheimer's dementia
arm group label: Cognitively normal controls (CNC)
arm group label: Mild cognitive impairment (MCI)
arm group label: Subjective cognitive decline (SCD)
arm group label: Vascular dementia
intervention type: Diagnostic Test
intervention name: MRI
description: MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients
arm group label: Alzheimer's dementia
arm group label: Cognitively normal controls (CNC)
arm group label: Mild cognitive impairment (MCI)
arm group label: Subjective cognitive decline (SCD)
arm group label: Vascular dementia
intervention type: Biological
intervention name: Blood tests
description: Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis
arm group label: Alzheimer's dementia
arm group label: Cognitively normal controls (CNC)
arm group label: Mild cognitive impairment (MCI)
arm group label: Subjective cognitive decline (SCD)
arm group label: Vascular dementia
intervention type: Diagnostic Test
intervention name: EEG with event-related potential (ERP)
description: 128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients
arm group label: Cognitively normal controls (CNC)
arm group label: Mild cognitive impairment (MCI)
arm group label: Subjective cognitive decline (SCD)
intervention type: Diagnostic Test
intervention name: Amyloid PET CT
description: F18 Flutametamol PET CT for selected patients
arm group label: Alzheimer's dementia
arm group label: Mild cognitive impairment (MCI)
arm group label: Subjective cognitive decline (SCD)
arm group label: Vascular dementia
Venous blood at baseline and at yearly follow up
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Joseph SK Kwan, MD
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Joseph SK Kwan, MD
phone: +85222554769
email: jskkwan@hku.hk
last name: Charlene Cheng, BA
phone: +85222554769
email: cychar@hku.hk
facility: 
status: Recruiting
contact: 
contact backup: 
country: Hong Kong
url: http://hub.hku.hk/cris/rp/rp01868
description: Profile of PI
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr Joseph SK Kwan
investigator title: Clinical Associate Professor
mesh term: Dementia
mesh term: Alzheimer Disease
mesh term: Dementia, Vascular
mesh term: Cognitive Dysfunction
mesh term: Neurocognitive Disorders
sharing ipd: Yes
ipd description: Share with Dementias Platform UK (www.dementiasplatform.uk)
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Due to be shared from 2017, indefinitely.
ipd access criteria: Via Dementias Platform UK (www.dementiasplatform.uk)
ipd url: http://www.dementiasplatform.uk