Dementia AlzheimersNCT06072014
ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia (Phase 2)
A study testing Virtual reality in people with Dementia Alzheimers, run by Augmented eXperience E-health Laboratory at 1 site in Philippines.
Trial summary
The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the second phase. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePhilippines
- Study dates
- 10 Jul 2023to Dec 2023
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years old or older
- Diagnosed with mild to moderate Alzheimer's dementia according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Montreal Cognitive Assessment-Philippines (MOCA-P) score of 10-20 inclusive
- Neuropsychiatric Inventory (NPI-12) score 1-50 inclusive
- Reisberg Scale Stage 4-5 inclusive
- Stable dose of antidepressants for the past 6 weeks
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- Stable dose of antipsychotics for the past 4 weeks
- Able to walk unassisted or with minimal assistance, with or without assistive device
- No other explanation for condition based on reasonable clinical diagnostics
Who cannot join
- Have mild cognitive impairment (no dementia)
- Have MOCA-P score less than 10 or more than 20
- Other non-amnestic dementia syndromes
- Have receptive aphasia
- Have significant visual or hearing impairment
- Have an active psychiatric disorder prior to Alzheimer dementia diagnosis
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- Had previous episodes of seizures, diagnosis of epilepsy, or intake of antiepileptic or seizure medications
- Have quadriplegia or paralysis of the dominant hand
- Have a history of motion sickness
- Experience claustrophobia
- Have a diagnosis of a terminal illness or a life expectancy of less than one year
Trial locations and contacts
1 site in 1 country.
Philippines1 site, 1 recruiting
- Recruiting
University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory
Manila, National Capital Region, 1000
Maria Eliza R. Aguila, PhD, +639178212563, mraguila1@up.edu.ph
About this study
Official title: Developing Immersive Gamification Technology Systems for the Management of Patients With Alzheimer's Disease With Behavioral and Psychological Symptoms of Dementia (Phase 2 Trial)
The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the second phase. The phase 2 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its clinical effectiveness, safety, usability, and acceptability among patients with mild to moderate Alzheimer's disease.
- Conditions
- Dementia Alzheimers
- Being tested
- Virtual reality
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
A role-playing game with activities based on existing therapy activities (such as orientation therapy, reminiscence therapy, art therapy, and music therapy) that are used to manage behavioral and psychological symptoms of dementia
| Study group | Role | What they receive |
|---|---|---|
| Head-mounted display (HMD) | Experimental | The HMD system uses a commercially available virtual headset, the Oculus/Meta Quest 2, which allows a user to view a virtual environment in 360 degrees and to interact with the environment using hand-tracking technology (i.e., when a user's hand is projected into the virtual world to be used for interactions and gestures). Receives: Other: Virtual reality |
| Semi-cave automatic virtual environment (semi-CAVE) | Experimental | The semi-CAVE system uses projectors and projector screens to provide a 270-degree view of the virtual environment. These projectors are connected to a powerful workstation (desktop computer), which uses HTC Vive trackers and base stations to track user movements and interactions Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12
The NPI evaluates the degree and severity of BPSDs and the distress it causes the primary caregiver. Scores range from 0 to 120 where higher scores indicate greater psychiatric disturbance.
Measured: Within one hour after completion of the fourth session
Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire
The VRSQ will measure a participant's experience with the following symptoms: general discomfort, fatigue, eye strain, difficulty focusing, headache, fullness of head, blurring of vision, dizziness (when eyes are closed), and vertigo. Symptoms will be rated on a 4-point scale: 0 or None, 1 or Slight, 2 or Moderate, and 3 or Severe.
Measured: Immediately after each intervention, within an hour of completion of the virtual reality game
Usability of the virtual reality intervention will be assessed using the System Usability Scale
The SUS is a 10-item questionnaire that is widely used in the evaluation of various kinds and aspects of technology. Each question has five response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average.
Measured: Immediately after each intervention, within an hour of completion of the virtual reality game
Secondary outcomes (5)
Cognitive function will be assessed using MOCA-P
Montreal Cognitive Assessment-Philippines (MOCA-P) is a 30-item test that takes about 10-12 minutes to complete. The test measures different cognitive domains such as visuospatial/executive, naming, memory, attention, language, abstraction, and orientation.
Measured: Within one hour after completion of the fourth session
Cognitive function will be assessed using MMSE
The Mini-Mental State Exam (MMSE) is a 30-item test for cognitive function. It assesses attention, orientation, memory, registration, recall, calculation, language, and an individual's ability to draw a complex polygon.
Measured: Within one hour after completion of the fourth session
Cognitive function will be assessed using ADAS-Cog
The cognitive subscale of the Alzheimer's Disease Assessment Scale (ADAS-Cog) is an 11-item tool for the assessment of the following tasks: word recall, naming objects and fingers, commands, constructional praxis, ideational praxis, orientation, word recognition, and language.
Measured: Within one hour after completion of the fourth session
Activities of daily living will be assessed using ADCS-ADL
The Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) is a 24-item assessment on activities of daily living within the past four weeks
Measured: Within one hour after completion of the fourth session
Health-related quality of life will be assessed using DEMQOL
The Health-related quality of life for people with dementia (DEMQOL) is a 28-item self-report measure of quality of life specific for persons with mild-to-moderate dementia. It covers four dimensions of quality of life, namely, daily activities, memory, negative emotion, and positive emotion.
Measured: Within one hour after completion of the fourth session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start10 Jul 2023
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia AlzheimersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augmented eXperience E-health Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Veeda Michelle M. Anlacan, MD, Principal investigator, University of the Philippines Manila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072014
- Sponsor's protocol ID
- AXEL0003
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anlacan, V.M.M. et al. (2023). Application Design for a Virtual Reality Therapy Game for Patients with Behavioral and Psychological Symptoms of Dementia. In: Krouska, A., Troussas, C., Caro, J. (eds) Novel & Intelligent Digital Systems: Proceedings of the 2nd International Conference (NiDS 2022). NiDS 2022. Lecture Notes in Networks and Systems, vol 556. Springer, Cham. https://doi.org/10.1007/978-3-031-17601-2_15
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Immersive Gamification Technology Systems for the Management of Patients With Alzheimer's Disease With Behavioral and Psychological Symptoms of Dementia (Phase 2 Trial)
- ClinicalTrials.gov ID
- NCT06072014
- Acronym / sponsor ID
- AXEL0003
- Conditions
- Dementia Alzheimers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Augmented eXperience E-health LaboratoryUniversity, hospital or other
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Oct 2023 (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.
The proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the second phase. The phase 2 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its clinical effectiveness, safety, usability, and acceptability among patients with mild to moderate Alzheimer's disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head-mounted display (HMD) | Experimental | Other: Virtual realityThe HMD system uses a commercially available virtual headset, the Oculus/Meta Quest 2, which allows a user to view a virtual environment in 360 degrees and to interact with the environment using hand-tracking technology (i.e., when a user's hand is projected into the virtual world to be used for interactions and gestures). |
| Semi-cave automatic virtual environment (semi-CAVE) | Experimental | Other: Virtual realityThe semi-CAVE system uses projectors and projector screens to provide a 270-degree view of the virtual environment. These projectors are connected to a powerful workstation (desktop computer), which uses HTC Vive trackers and base stations to track user movements and interactions |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 60 years old or older
- Diagnosed with mild to moderate Alzheimer's dementia according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
- Montreal Cognitive Assessment-Philippines (MOCA-P) score of 10-20 inclusive
- Neuropsychiatric Inventory (NPI-12) score 1-50 inclusive
- Reisberg Scale Stage 4-5 inclusive
Key exclusion criteria (11 listed)
- Have mild cognitive impairment (no dementia)
- Have MOCA-P score less than 10 or more than 20
- Other non-amnestic dementia syndromes
- Have receptive aphasia
- Have significant visual or hearing impairment
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 |
|---|---|---|
| Virtual realityA role-playing game with activities based on existing therapy activities (such as orientation therapy, reminiscence therapy, art therapy, and music therapy) that are used to manage behavioral and psychological symptoms of dementia | Other | Head-mounted display (HMD), Semi-cave automatic virtual environment (semi-CAVE) |
Primary outcome
Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12
Time frame: Within one hour after completion of the fourth session
The NPI evaluates the degree and severity of BPSDs and the distress it causes the primary caregiver. Scores range from 0 to 120 where higher scores indicate greater psychiatric disturbance.
Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire
Time frame: Immediately after each intervention, within an hour of completion of the virtual reality game
The VRSQ will measure a participant's experience with the following symptoms: general discomfort, fatigue, eye strain, difficulty focusing, headache, fullness of head, blurring of vision, dizziness (when eyes are closed), and vertigo. Symptoms will be rated on a 4-point scale: 0 or None, 1 or Slight, 2 or Moderate, and 3 or Severe.
Usability of the virtual reality intervention will be assessed using the System Usability Scale
Time frame: Immediately after each intervention, within an hour of completion of the virtual reality game
The SUS is a 10-item questionnaire that is widely used in the evaluation of various kinds and aspects of technology. Each question has five response options ranging from 'Strongly agree' to 'Strongly disagree', which has a corresponding number value. Each response is added and multiplied by 2.5 to obtain the final score that ranges from 0 to 100. A SUS score above 68 is considered above average.
5 secondary outcomes
Cognitive function will be assessed using MOCA-P
Time frame: Within one hour after completion of the fourth session
Cognitive function will be assessed using MMSE
Time frame: Within one hour after completion of the fourth session
Cognitive function will be assessed using ADAS-Cog
Time frame: Within one hour after completion of the fourth session
Activities of daily living will be assessed using ADCS-ADL
Time frame: Within one hour after completion of the fourth session
Health-related quality of life will be assessed using DEMQOL
Time frame: Within one hour after completion of the fourth session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- BackgroundAnlacan, V.M.M. et al. (2023). Application Design for a Virtual Reality Therapy Game for Patients with Behavioral and Psychological Symptoms of Dementia. In: Krouska, A., Troussas, C., Caro, J. (eds) Novel & Intelligent Digital Systems: Proceedings of the 2nd International Conference (NiDS 2022). NiDS 2022. Lecture Notes in Networks and Systems, vol 556. Springer, Cham. https://doi.org/10.1007/978-3-031-17601-2_15
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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.
Veeda Michelle M. Anlacan, MD principal investigator
University of the Philippines Manila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Dementia Alzheimers, run by Augmented eXperience E-health Laboratory at 1 site in Philippines.
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 9 inclusion and 11 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Roland Dominic G. Jamora, MD, PhD (+639985438062, rgjamora@up.edu.ph), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12 (time frame: Within one hour after completion of the fourth session). The study lists 3 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 NCT06072014, which also lists 1 linked publication.
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 10 Oct 2023.