Clinical trial NCT06072014: ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia (Phase 2)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia Alzheimers
Lead sponsor: Augmented eXperience E-health Laboratory
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Incidence of behavioral and psychological symptoms of dementia will be assessed using the Neuropsychiatric Inventory-12
timeFrame: Within one hour after completion of the fourth session
measure: Incidence of virtual reality sickness symptoms will be assessed using the Virtual Reality Sickness Questionnaire
timeFrame: Immediately after each intervention, within an hour of completion of the virtual reality game
measure: Usability of the virtual reality intervention will be assessed using the System Usability Scale
timeFrame: Immediately after each intervention, within an hour of completion of the virtual reality game
Secondary outcomes:
measure: Cognitive function will be assessed using MOCA-P
timeFrame: Within one hour after completion of the fourth session
measure: Cognitive function will be assessed using MMSE
timeFrame: Within one hour after completion of the fourth session
measure: Cognitive function will be assessed using ADAS-Cog
timeFrame: Within one hour after completion of the fourth session
measure: Activities of daily living will be assessed using ADCS-ADL
timeFrame: Within one hour after completion of the fourth session
measure: Health-related quality of life will be assessed using DEMQOL
timeFrame: Within one hour after completion of the fourth session
Other outcomes:
measure: Acceptability
timeFrame: Within one day after completing virtual reality experience
Locations:
city: City Of Manila
country: Philippines
facility: University of the Philippines College of Allied Medical Professions Immersive Technology Laboratory
state: National Capital Region
Study officials:
affiliation: University of the Philippines Manila
name: Veeda Michelle M. Anlacan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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