Older Adults With Mild Neurocognitive DisordersVRNCT04600726
Application of VR-based Working Memory Screening Test
An observational study of Older Adults With Mild Neurocognitive Disorders and Older Adults With Non-communicable Diseases, run by The Hong Kong Polytechnic University.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults With Mild Neurocognitive Disorders, Older Adults With Non-communicable Diseases, Healthy Age-matched Older Adults
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 31 Dec 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Older adults who are community dwelling
Who may be able to join
- the ability to understand verbal and written Chinese instructions
- the ability and willingness to provide informed consent and sign the relevant document.
Who cannot join
- a history of substance abuse including alcohol, drugs, or any medication/substances indicative of chronic abuse;
- participants with major NCD.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Application of VR-based Working Memory Screening Test to Facilitate Early Detection of Dementia
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
Read the detailed description
The proposed research aims to study the ability of VRWMT to discriminate between older adults with known mild NCD, healthy age-matched older adults and participants with non-communicable diseases and to predict their deterioration in cognitive function over a period of 12 months. Moreover, this study is to characterize and evaluate any concurrent validity between emergence of deterioration in the VRWMT and clinical tools of functional performance in older adults. Additionally, the potential of inflammatory and metabolic dysregulation biomarkers to increase our ability to detect early NCD risk over and above the predictive validity of the VRWMT. The study findings will bring both social and clinical significance to ageing and NCD research. The combination of behavioural and biomarkers of pathological significance offers an innovative approach that potentially addresses the limitations intrinsic to either measure alone.
- Conditions
- Older Adults With Mild Neurocognitive Disorders, Older Adults With Non-communicable Diseases, Healthy Age-matched Older Adults
- Being tested
- no intervention
- Keywords
- Cognitive function screening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no interventioni
| Study group | Role | What they receive |
|---|---|---|
| older adults with known mild NCD | Older adults with known mild neuro-cognitive disorders Receives: Other: no intervention | |
| older adults with non-communicable diseases | older adults with non-communicable diseases such as diabetics, hypertension and chronic obstructive airway diseases Receives: Other: no intervention | |
| Older adults with healthy condition | Older adults who are free from neuro-cognitive disorders and non-communicable diseases Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed matching-to-place (DMP)
a prototypical working memory test implemented in a virtual reality environment of the VRWMT
Measured: 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.
Measured: 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
Measured: 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)
Measured: 5 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Feb 2021 (estimated)
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Older Adults With Mild Neurocognitive DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Neuroscience, Psychology and Behavior. The University of Leicester, School of Psychology, The University of Nottingham, The Alice Ho Miu Ning Nethersole Hospital
- Responsible party
- Principal investigator, Dr Frank LAI, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600726
- Sponsor's protocol ID
- VR_Clinical Trial
- Acronym
- VR
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Publications
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.
PubMed 27659539Daugherty 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.
PubMed 25838036Folley 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.
PubMed 19948225Daugherty 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.
PubMed 24860019
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of VR-based Working Memory Screening Test to Facilitate Early Detection of Dementia
- ClinicalTrials.gov ID
- NCT04600726
- Acronym / sponsor ID
- VR / VR_Clinical Trial
- Conditions
- Older Adults With Mild Neurocognitive Disorders, Older Adults With Non-communicable Diseases, Healthy Age-matched Older Adults
- Keywords
- Cognitive function screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Department of Neuroscience, Psychology and Behavior. The University of Leicester, School of Psychology, The University of Nottingham, The Alice Ho Miu Ning Nethersole Hospital
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The proposed research aims to study the ability of VRWMT to discriminate between older adults with known mild NCD, healthy age-matched older adults and participants with non-communicable diseases and to predict their deterioration in cognitive function over a period of 12 months. Moreover, this study is to characterize and evaluate any concurrent validity between emergence of deterioration in the VRWMT and clinical tools of functional performance in older adults. Additionally, the potential of inflammatory and metabolic dysregulation biomarkers to increase our ability to detect early NCD risk over and above the predictive validity of the VRWMT. The study findings will bring both social and clinical significance to ageing and NCD research. The combination of behavioural and biomarkers of pathological significance offers an innovative approach that potentially addresses the limitations intrinsic to either measure alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| older adults with known mild NCD | – | Other: no interventionOlder adults with known mild neuro-cognitive disorders |
| older adults with non-communicable diseases | – | Other: no interventionolder adults with non-communicable diseases such as diabetics, hypertension and chronic obstructive airway diseases |
| Older adults with healthy condition | – | Other: no interventionOlder adults who are free from neuro-cognitive disorders and non-communicable diseases |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Older adults who are community dwelling
Key inclusion criteria (2 listed)
- the ability to understand verbal and written Chinese instructions
- the ability and willingness to provide informed consent and sign the relevant document.
Key exclusion criteria (2 listed)
- a history of substance abuse including alcohol, drugs, or any medication/substances indicative of chronic abuse;
- participants with major NCD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno interventioni | Other | Older adults with healthy condition, older adults with known mild NCD, older adults with non-communicable diseases |
Primary outcome
Delayed matching-to-place (DMP)
Time frame: 20 mins
a prototypical working memory test implemented in a virtual reality environment of the VRWMT
The Montreal Cognitive Assessment - Hong Kong Version
Time frame: 15 mins
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.
The Chinese Multiple Errands Test
Time frame: 20 mins
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
Biological biomarkers for older adults with NCDs and Healthy Control
Time frame: 5 mins
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Background: PubMed 27659539Daugherty 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.
- Background: PubMed 25838036Daugherty 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.
- Background: PubMed 19948225Folley 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.
- Results publication: PubMed 24860019Daugherty 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.
- Individual participant dataSharing planned: No. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Adults With Mild Neurocognitive Disorders and Older Adults With Non-communicable Diseases, run by The Hong Kong Polytechnic University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank HY Lai, Phd (91448014, frank.hy.lai@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delayed matching-to-place (DMP) (time frame: 20 mins). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600726, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.