Mild to Moderate DementiaNCT07033468
The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia
A study testing VR-WLC and CTL-VR in people with Mild to Moderate Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This project will explore the feasibility and efficacy of the fully immersive virtual reality leisure cognitive training tool developed by Chang Gung University in patients with mild to moderate dementia. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild to Moderate Dementia
- What is being tested?
- VR-WLC and CTL-VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 55 years;
- Diagnosed with mild or moderate dementia (primarily degenerative dementia) by a consulting physician or based on past medical records;
- A score of at least 11 but no more than 23 on the Mini-Mental State Examination (MMSE);
- Has at least one family member or a regularly contacted friend (with the person's mobile number and contact at least once a week);
- Able to walk independently and complete the Timed Up \& Go (TUG) test;
- Able to follow instructions with or without the assistance of a guardian or therapist;
- If the assessment indicates moderate dementia, further evaluation will be conducted to determine whether the participant has sufficient capacity to provide informed consent. If their capacity is found to be impaired, the study will be explained to their legal representative
Who cannot join
- Dementia with Lewy Bodies and other dementia types resulting from specific causes, such as Huntington's Disease, substance addiction, central nervous system infections, nutritional deficiencies, and metabolic disorders.
- Severe health conditions that may hinder safe participation, such as respiratory distress, severe cardiovascular disease, or brain tumors.
- A psychiatric diagnosis of psychosis within the past six months.
- Diagnosis of Korsakoff syndrome.
- History of substance addiction.
- Severe hearing impairment or color blindness.
- History of severe vertigo or epilepsy.
- Concurrent participation in other studies that may affect cognitive function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tucheng Hospital, New Taipei City, commissioned and operated by Chang Gung Medical Foundation.
New Taipei City
Ching-Yi Wu, ScD, +886-3-2118800 Ext. 5761, cywu@mail.cgu.edu.tw
About this study
This project will explore the feasibility and efficacy of the fully immersive virtual reality leisure cognitive training tool developed by Chang Gung University in patients with mild to moderate dementia. The feasibility study will assess the feasibility and emotion-related indicators of 10 patients before and after a single training session. The efficacy study is planned to adopt a crossover randomized controlled trial, recruiting 30 patients for 15 sessions, each lasting 65 minutes, conducted three times a week. The assessment will include tests on the primary variable of cognitive function and secondary variables such as activities of daily living, quality of life, emotion, clinical symptoms, etc.
- Conditions
- Mild to Moderate Dementia
- Being tested
- VR-WLC, CTL-VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-WLCDevice
First, conduct the Virtual Reality (VR) training activity. After the evaluation is completed, proceed to the Waitlist Control (WLC) session, approximately 5 to 10 weeks later.
CTL-VRDevice
First, conduct the Control (CTL) session for approximately 5 to 10 weeks. After the evaluation is completed, proceed to the Virtual Reality (VR) training activity.
| Study group | Role | What they receive |
|---|---|---|
| VR training therapy | Experimental | Guide the patient through a 5-minute warm-up, which mainly involves explaining, familiarizing with, or reviewing VR operations. After the warm-up, proceed with the first part of the VR gardening training for 10 minutes, followed by 5 minutes of eye and stretching exercises. Then, continue with the second part of the VR gardening training for another 10 minutes, followed by 5 minutes of eye massage and stretching exercises. This sequence is repeated for a total of four cycles. Receives: Device: VR-WLC; Device: CTL-VR |
| Waitlist control session | Other | During the waitlist period, patients will not receive any training but will receive regular phone calls to ensure equal attention. Receives: Device: VR-WLC; Device: CTL-VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke.
Minimum: 0 (worst performance) Maximum: 30 (best performance) The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Stroop test
The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition.Minimum: 0 , Maximum: but typically no upper limit. Higher scores indicate worse performance (greater cognitive interference and slower response time).
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Color trials test
For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.Minimum: Greater than 1 second (best performance) Maximum: No upper limit .Higher scores indicate worse performance (longer completion time and greater cognitive impairment).
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Frontal Assessment Battery
This study utilizes this scale to assess various aspects of frontal lobe function, including executive function, behavioral regulation, and planning. The test consists of six subtests: Similarities, Verbal Fluency, Motor Sequencing, Conflicting Instructions, Go-No-Go, and Comprehending Behavior. Each subtest is scored from 0 to 3, with a total possible score of 18 points. The Taiwanese version of the frontal assessment scale has demonstrated good reliability and validity, showing consistency with tconsistency with the original version and strong construct validity.
Minimum: 0 (worst performance) Maximum: 18 (best performance) Higher scores indicate better frontal lobe function, while lower scores suggest greater impairment.
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Secondary outcomes (6)
Change scores of Barthel Index
It is a commonly used assessment scale for evaluating activities of daily living (ADL), primarily designed to measure the effectiveness of treatment and the degree of functional decline in patients. The Barthel Index consists of 10 assessment items, each assigned a corresponding score (0, 5, or 10 points), with a maximum total score of 100 points. A lower total score indicates greater dependence on others and a reduced ability to perreduced ability to perform daily self-care activities.
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL
The Amsterdam Instrumental Activity of Daily Living (A-IADL) is an adaptive and computerized questionnaire designed to assess impairments in instrumental activities of daily living (IADL) in (early) dementia. The questionnaire is completed by a caregiver, such as a relative or friend. Each item has a 5-point scale response option (scored 0-4). The scoring of the Amsterdam Instrumental Activity of Daily Living is calculated using item response theory .Lower scores indicating poorer performance. Higher scores indicate better performance in instrumental activities of daily living, while lower scores suggest greater impairment.
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of The Chinese Dementia-Quality of Life instrument, DQoL
This study utilizes the Chinese version of the Quality of Life in Dementia (QOL-D) assessment tool to evaluate the physical and mental health of individuals with dementia and to understand the impact of VR cognitive training on their well-being. The questionnaire comprises five dimensions: positive emotions, negative emotions, sense of belonging, self-esteem, and aesthetics, with a total of 29 items. Each item is rated on a scale from 0 to 5, indicating varying levels of quality. This questionnaire is applicable to individuals with mild to moderate dementia, and its Chinese version has been validated among dementia patients in Taiwan.
Minimum: 0 (worst quality of life) Maximum: 145 (best quality of life, calculated as 29 items × maximum score of 5 per item).
Higher scores indicate better quality of life, while lower scores suggest poorer well-being.
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of The Cornell Scale for Depression in Dementia Chinese version
This study utilizes the Chinese version of the Cornell Scale for Depression in Dementia (CSDD) to assess depressive symptoms in individuals with dementia before and after the intervention, aiming to understand the impact of the intervention on their quality of life. The scale covers five dimensions: mood-related signs, behavioral disturbances, physical signs, cyclic functions, and ideational disturbances, with a total of 19 items. Each item is scored based on severity, ranging from 0 (no symptoms) to 2 (severe symptoms). A total score above 10 suggests a possible diagnosis of depression, while a score below 6 indicates that depression can be ruled out. The Chinese version has established reliability and validity, demonstrating good psychometric properties.
Minimum: 0 (no depressive symptoms) Maximum: 38 (severe depressive symptoms, calculated as 19 items × maximum score of 2 per item) Higher scores indicate more severe depressive symptoms, while lower scores suggest
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Clinical Dementia Rating, CDR
This study utilizes the Clinical Dementia Rating (CDR) scale to assess the severity of cognitive decline in individuals with dementia. The evaluation is conducted by professional physicians and clinical psychologists to comprehensively assess the cognitive function of participants. The assessment includes six functional domains: memory, orientation, judgment and problem-solving, community affairs, home and hobbies, and personal care. Based on the scoring criteria of the scale, a final score is derived to represent the current severity of dementia. This score serves as an important reference for tracking the progression of the disease over time. The Chinese version of the CDR scale has been validated and has demonstrated good reliability and validity Minimum: 0 (normal cognitive function) Maximum: 3 (severe dementia) Higher scores indicate more severe cognitive impairment.
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Behavioral and Psychological Symptoms of Dementia, BPSD
We use behavioral and psychological symptoms of dementia (BPSD) to assess the behavioral and psychological aspects of individuals with dementia. Dementia is not only characterized by cognitive impairment but is also frequently accompanied by non-cognitive symptoms such as depression, anxiety, delusions, hallucinations, behavioral disturbances, and other psychiatric symptoms. According to a past study conducted in Taiwan, the prevalence of non-cognitive symptoms among individuals with dementia was as high as 30% (Fuh \& Liu, 2006). BPSD is also the primary source of burden for family caregivers of dementia patients. Additionally, compared to improvements in cognitive function, BPSD is often more noticeably improved in clinical settings.
Minimum: 0 Maximum: Depends on the number of items and scoring system of the specific BPSD scale used Higher scores indicate more severe behavioral and psychological symptoms in individuals with dementia, while lower scores suggest fewer or no symptoms
Measured: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate DementiaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-yi Wu, ScD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033468
- Sponsor's protocol ID
- 202400517B0
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and the Efficacy of the Full-immersive Virtual Reality Cognitive Training in Patients With Mild or Moderate Dementia
- ClinicalTrials.gov ID
- NCT07033468
- Acronym / sponsor ID
- 202400517B0
- Conditions
- Mild to Moderate Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Jun 2025 (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.
This project will explore the feasibility and efficacy of the fully immersive virtual reality leisure cognitive training tool developed by Chang Gung University in patients with mild to moderate dementia. The feasibility study will assess the feasibility and emotion-related indicators of 10 patients before and after a single training session. The efficacy study is planned to adopt a crossover randomized controlled trial, recruiting 30 patients for 15 sessions, each lasting 65 minutes, conducted three times a week. The assessment will include tests on the primary variable of cognitive function and secondary variables such as activities of daily living, quality of life, emotion, clinical symptoms, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR training therapy | Experimental | Device: VR-WLC, Device: CTL-VRGuide the patient through a 5-minute warm-up, which mainly involves explaining, familiarizing with, or reviewing VR operations. After the warm-up, proceed with the first part of the VR gardening training for 10 minutes, followed by 5 minutes of eye and stretching exercises. Then, continue with the second part of the VR gardening training for another 10 minutes, followed by 5 minutes of eye massage and stretching exercises. This sequence is repeated for a total of four cycles. |
| Waitlist control session | Other | Device: VR-WLC, Device: CTL-VRDuring the waitlist period, patients will not receive any training but will receive regular phone calls to ensure equal attention. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age over 55 years;
- Diagnosed with mild or moderate dementia (primarily degenerative dementia) by a consulting physician or based on past medical records;
- A score of at least 11 but no more than 23 on the Mini-Mental State Examination (MMSE);
- Has at least one family member or a regularly contacted friend (with the person's mobile number and contact at least once a week);
- Able to walk independently and complete the Timed Up \& Go (TUG) test;
Key exclusion criteria (8 listed)
- Dementia with Lewy Bodies and other dementia types resulting from specific causes, such as Huntington's Disease, substance addiction, central nervous system infections, nutritional deficiencies, and metabolic disorders.
- Severe health conditions that may hinder safe participation, such as respiratory distress, severe cardiovascular disease, or brain tumors.
- A psychiatric diagnosis of psychosis within the past six months.
- Diagnosis of Korsakoff syndrome.
- History of substance addiction.
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 |
|---|---|---|
| VR-WLCFirst, conduct the Virtual Reality (VR) training activity. After the evaluation is completed, proceed to the Waitlist Control (WLC) session, approximately 5 to 10 weeks later. | Device | VR training therapy, Waitlist control session |
| CTL-VRFirst, conduct the Control (CTL) session for approximately 5 to 10 weeks. After the evaluation is completed, proceed to the Virtual Reality (VR) training activity. | Device | VR training therapy, Waitlist control session |
Primary outcome
Change scores of Montreal Cognitive Assessment
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
The Montreal Cognitive Assessment (MoCA) will be used to assess general cognitive functions. It examines several cognitive domains with a total score of 30 and higher values indicate better cognitive functions. The MoCA has been shown to be a valid and promising tool to evaluate the global cognitive function in patients with stroke. Minimum: 0 (worst performance) Maximum: 30 (best performance) The psychometric properties of MoCA are good to excellent for patients with cerebrovascular diseases.
Change scores of Stroop test
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
The participants will be tested under congruent and incongruent conditions. In the congruent condition, the participant will name the color ink of a word which is consistent with the written color name; whereas in the incongruent condition the participant will name the color ink differs from the written color name. The time to complete the task will be calculated for each condition.Minimum: 0 , Maximum: but typically no upper limit. Higher scores indicate worse performance (greater cognitive interference and slower response time).
Change scores of Color trials test
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
For Part 1, the respondent uses a pencil to rapidly connect circles numbered 1-25 in sequence. For Part 2, the respondent rapidly connects numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.Minimum: Greater than 1 second (best performance) Maximum: No upper limit .Higher scores indicate worse performance (longer completion time and greater cognitive impairment).
Change scores of Frontal Assessment Battery
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
This study utilizes this scale to assess various aspects of frontal lobe function, including executive function, behavioral regulation, and planning. The test consists of six subtests: Similarities, Verbal Fluency, Motor Sequencing, Conflicting Instructions, Go-No-Go, and Comprehending Behavior. Each subtest is scored from 0 to 3, with a total possible score of 18 points. The Taiwanese version of the frontal assessment scale has demonstrated good reliability and validity, showing consistency with tconsistency with the original version and strong construct validity. Minimum: 0 (worst performance) Maximum: 18 (best performance) Higher scores indicate better frontal lobe function, while lower scores suggest greater impairment.
6 secondary outcomes
Change scores of Barthel Index
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Amsterdam Instrumental Activity of Daily Living,A-IADL
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of The Chinese Dementia-Quality of Life instrument, DQoL
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of The Cornell Scale for Depression in Dementia Chinese version
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Clinical Dementia Rating, CDR
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Change scores of Behavioral and Psychological Symptoms of Dementia, BPSD
Time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Mild to Moderate Dementia
Active, not recruitingPhase 2/3
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Dementia Moderate, Dementia, Mild
Recruiting
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
Traumatic Brain Injury, Mild Traumatic Brain Injury
RecruitingPhase 1/2
Large-coil Parietal Repetitive Transcranial Magnetic Stimulation (rTMS) for Alzheimer Disease (AD)
Alzheimer&Amp;Amp;#39;s Disease, Alzheimer Disease
Recruiting
Pain With Dementia
Pain, Dementia, Mild
Not yet recruiting
STRONGER 60+: Assessing the Clinical Effectiveness and Delivery of an Adapted FINGER Model for Brain Health in Primary Care
Older Adults at High Risk for MCI, Older Adults With Mild to Moderate Level of Dementia
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.
Ching-yi Wu, ScD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR-WLC and CTL-VR in people with Mild to Moderate Dementia, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ching-yi Wu, ScD (#886-3-2118800 ext. 5761, cywu@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change scores of Montreal Cognitive Assessment (time frame: Before the intervention arms within a week, within a week after the waiting period ends, and within a week after the last treatment .). 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?
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 26 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.