NCT04600726

Brief Summary

We propose to validate an interactive, immersive spatial memory test from the laboratory test. This VR-based working memory test (VRWMT) is a first-person, self-pacing game embedded within a virtual reality environment, the program is easily implemented with minimal instructions and no supervision that can be community-users friendly. It is specifically designed to assess rapid spatial working memory - a common deficit in all NCD subtypes. Its ability to detect pathological models of dementia, age-related deterioration, and hippocampal dysfunction are well established in literature

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

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

First Submitted

Initial submission to the registry

October 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

1.9 years

First QC Date

October 19, 2020

Last Update Submit

October 19, 2020

Conditions

Keywords

Cognitive function screening

Outcome Measures

Primary Outcomes (4)

  • Delayed matching-to-place (DMP)

    a prototypical working memory test implemented in a virtual reality environment of the VRWMT

    20 mins

  • The Montreal Cognitive Assessment - Hong Kong Version

    The MoCA-HK is an examiner-rated cognitive screening test that evaluates visuospatial functions, naming, attention and working memory, language, abstraction, and orientation, commonly affected in NCD including Alzheimer's disease, stroke, and vascular dementia. It is a validated tool for detecting cognitive impairment in Chinese Hong Kong population at early stages. It is a common tool in practical practice that can be under 15 minutes. MoCA scores range from 0 to 30. Subjects with a score of above 21 will be classified as "healthy controls", while 21 or below will be included in the mild NCD group in the present study.

    15 mins

  • The Chinese Multiple Errands Test

    A functional performance measure of executive function that identifies abnormalities known for its ecological validity through assessment of real-world daily living activities. The proposed study will evaluate the ability of working memory (as a component to executive function) from VRWMT to predict executive functions (globally) across the six scores obtained from the Chinese Multiple Errands Test

    20 mins

  • Biological biomarkers for older adults with NCDs and Healthy Control

    The panel of biomarkers covers five immune cytokines and two metabolic markers (including serum IL-1B,Interleukin 6, Interleukin 10, Interleukin 33, Tumor Necrosis Factor alpha, Leptin and Glycosylated haemoglobin A1c (HbA1c)

    5 mins

Study Arms (3)

older adults with known mild NCD

Older adults with known mild neuro-cognitive disorders

Other: no intervention

older adults with non-communicable diseases

older adults with non-communicable diseases such as diabetics, hypertension and chronic obstructive airway diseases

Other: no intervention

Older adults with healthy condition

Older adults who are free from neuro-cognitive disorders and non-communicable diseases

Other: no intervention

Interventions

no interventioni

Older adults with healthy conditionolder adults with known mild NCDolder adults with non-communicable diseases

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Older adults who are community dwelling

You may qualify if:

  • the ability to understand verbal and written Chinese instructions
  • the ability and willingness to provide informed consent and sign the relevant document.

You may not qualify if:

  • a history of substance abuse including alcohol, drugs, or any medication/substances indicative of chronic abuse;
  • participants with major NCD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Daugherty AM, Raz N. A virtual water maze revisited: Two-year changes in navigation performance and their neural correlates in healthy adults. Neuroimage. 2017 Feb 1;146:492-506. doi: 10.1016/j.neuroimage.2016.09.044. Epub 2016 Sep 19.

    PMID: 27659539BACKGROUND
  • Daugherty AM, Bender AR, Yuan P, Raz N. Changes in Search Path Complexity and Length During Learning of a Virtual Water Maze: Age Differences and Differential Associations with Hippocampal Subfield Volumes. Cereb Cortex. 2016 Jun;26(6):2391-401. doi: 10.1093/cercor/bhv061. Epub 2015 Apr 1.

    PMID: 25838036BACKGROUND
  • Folley BS, Astur R, Jagannathan K, Calhoun VD, Pearlson GD. Anomalous neural circuit function in schizophrenia during a virtual Morris water task. Neuroimage. 2010 Feb 15;49(4):3373-84. doi: 10.1016/j.neuroimage.2009.11.034. Epub 2009 Dec 4.

    PMID: 19948225BACKGROUND
  • Daugherty AM, Yuan P, Dahle CL, Bender AR, Yang Y, Raz N. Path Complexity in Virtual Water Maze Navigation: Differential Associations with Age, Sex, and Regional Brain Volume. Cereb Cortex. 2015 Sep;25(9):3122-31. doi: 10.1093/cercor/bhu107. Epub 2014 May 23.

Biospecimen

Retention: SAMPLES WITHOUT DNA

The panel of biomarkers covers five immune cytokines and two metabolic markers (including serum IL-1B,Interleukin 6, Interleukin 10, Interleukin 33, Tumor Necrosis Factor alpha, Leptin and Glycosylated haemoglobin A1c (HbA1c)

Central Study Contacts

Frank HY Lai, Phd

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 19, 2020

First Posted

October 23, 2020

Study Start

February 1, 2021

Primary Completion

December 30, 2022

Study Completion

December 31, 2022

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

The data that support the findings of this study are available from the corresponding author upon reasonable request.