DementiaVRx@HomeNCT06568211
A Virtual Reality at Home Intervention for People Living With Dementia
A study testing Virtual Reality and Tablet-Only in people with Dementia, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The goal of the current study is to design and evaluate a virtual reality (VR) at-home intervention to facilitate communication between persons living with dementia (PLwD) and their family/friend care partners, and in turn improve their interpersonal relationships and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Virtual Reality and Tablet-Only
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 17 Nov 2022to Apr 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Given the nature of the study, the participating dyads will be required to have access to high-speed internet with a reliable WiFi connection. Additional inclusion/exclusion criteria are as follows:
PLwD inclusion criteria:
- report having dementia
- currently living at home
PLwD exclusion criteria:
- recent history of seizure, epilepsy, head trauma, or stroke
- pacemaker
- cervical conditions or injuries
- open face wounds
- alcohol-related dementia/Korsakoff syndrome
- having a Public Guardian and Trustee as substitute decision maker
Care partner inclusion criteria:
- identify as one of the primary care partners for the PLwD
- able to speak and understands English
- 18 years and older
Care partner exclusion criteria:
- professional/formal care partners for the PLwD
- unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
KITE Research Institute, University Health Network
Toronto, Ontario, M5G 2A2
About this study
Official title: VRx@Home: A Virtual Reality At-Home Intervention for Persons Living With Dementia and Their Care Partners
The goal of the current study is to design and evaluate a virtual reality (VR) at-home intervention to facilitate communication between persons living with dementia (PLwD) and their family/friend care partners, and in turn improve their interpersonal relationships and quality of life. The project also aims to provide a direct comparison of an immersive VR system with non-immersive tablet-based technology.
PLwD and care partner interactions will be recorded during each of the following sessions and then used for the primary measure of verbal and non-verbal communication.
- Picture Book condition (baseline): PLwD and care partner view pictures together on photo album
- VR condition: PLwD watch 360 degree videos on a VR and the care partner watches the same content concurrently on a paired tablet
- Table-Only condition: PLwD and care partner watch 360 videos together on the tablet
Read the detailed description
Head Mounted VR headsets allow a person to transport to alternate realities such as visiting another country, attending a concert or a sporting event. The evidence to date suggests that VR experiences have positive impact on the well-being of individuals living with dementia. Most of this work however, has been in more formal settings whether it's long-term care or community programs, with trained formal care partners or researchers. Further, little work has explored specifically communication outcomes within the family dynamics.
After obtaining informed consent, participants will complete a Demographic and Health History questionnaire, and then will be scheduled for their first home visit. During this session, researcher will provide training on how to use the devices, how to video-record the study sessions, and how to complete study questionnaires through the supplied laptop. The PLwD and care partner will also view a picture book together while their interaction is being recorded through a video-conferencing software.
Participants will then begin the four weeks of intervention, where they will either be placed in the VR first intervention condition for the first two week or the Tablet-only first intervention condition (weeks 1 and 2), and then they will switch and receive the other device in the following two weeks (weeks 3 and 4). Participants will receive additional at-home training in-between two intervention phases. Irrespective of the condition, once a week participants will have a session with researcher over a video-conferencing software, where they watch a 20 mins video sequence that has a combination of 4 videos of different themes (animal, entertainment, travel, and sports) preselected for them. This is then followed by a short semi-structured interview asking participants about their preferences and experience. In addition, participants are asked to try the devices on their own and record their interactions.
In addition to the video recording of sessions which will be used for analyses of verbal and non-verbal communication, and interview data, participants will be asked to complete a set of questionnaires at baseline, and after each phase of the intervention. They will also be given a journal to note down any additional information they would like to share beyond those captures in interviews and questionnaires.
After completing the study, a final semi-structure interview will be conducted with participants to evaluate the overall feasibility and effectiveness of intervention. Study will complete with a final home visit to pick up devices.
- Conditions
- Dementia
- Being tested
- Virtual Reality, Tablet-Only
- Keywords
- Virtual Reality, Tablet, Reminiscence, Verbal communication, Nonverbal communication, Interpersonal Relationship, Quality of Life, Well-Being, Person Living with Dementia, Care Partner
- Medical subject headings
- Dementia, Nonverbal Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Also called VR, HMD
Persons living with dementia (PLwD) will view 360-degree videos using a commercially-available Virtual Reality (VR) head mounted display that has built-in speakers. While wearing the VR headset, PLwD-participant will be able to visually explore the virtual environments by turning their head to face different directions. Care partner-participants will take part in the VR experience concurrently by viewing a tablet that is connected to the VR headset through the \"screen mirroring\" function.
Tablet-OnlyDevice
Also called Tablet
PLwD and care partner will view 360-degree videos together on a commercially-available tablet that has built-in speakers. They will be able to visually explore the virtual environment using the touch screen (dragging the view around with their fingers).
| Study group | Role | What they receive |
|---|---|---|
| Group A: VR first | Experimental | Those assigned to Group A will be placed in the Virtual Reality (VR) intervention phase first. All participants will begin with a baseline picture book condition (week 0), and then those in Group A, will complete the VR intervention condition in the first two weeks (weeks 1 \& 2). After completing the two weeks of VR intervention, participating families will be asked to complete a set of standardized questionnaires. The following next two weeks (weeks 3 \& 4), participants will complete the Tablet-only intervention phase. At the end of this phase, participating families will again complete the same standardized questionnaires and will participate in a semi-structured interview about their experiences. Each session is expected to include 20 minutes of VR exposure. Each session will also be video-recorded for later analyses. Receives: Device: Virtual Reality; Device: Tablet-Only |
| Group B: Tablet-only first | Experimental | Those assigned to Group B will be placed in the Tablet-only intervention phase first. All participants will begin with a baseline picture book condition (week 0), and then those in Group B, will complete the Tablet-only condition in the first two weeks (weeks 1 \& 2). After completing the two weeks of Tablet-only intervention, participating families will be asked to complete a set of standardized questionnaires. The following next two weeks (weeks 3 \& 4), participants will complete the VR intervention phase. At the end of this phase, participating families will again complete the same standardized questionnaires and will participate in a semi-structured interview about their experiences. Each session is expected to include 20 minutes of VR exposure. Each session will also be video-recorded for later analyses. Receives: Device: Virtual Reality; Device: Tablet-Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of conversation and dyadic interactions (observations)
Trained research assistants will code the video recordings for the quality of participation, support, and engagement using the standardized Measure of Participation in Conversation for Dementia (focused on PLwD) and Measure of Support in Conversation for Dementia (focused on Care partner).
Measured: Measures will be collected from baseline until the end of the intervention (week 4).
Quality of conversation and dyadic interactions (self-report)
Participating families will complete a communication questionnaire.
Measured: Measures will be collected from baseline until the end of the intervention (week 4).
Verbal Communication
Trained research assistants will code the video recordings for measures of verbal communication (e.g., utterance length, coherence, reminiscence). This data will be analyzed through both qualitative and quantitative methods.
Measured: Measures will be collected from baseline through the end of intervention (week 4)
Nonverbal Communication
Trained research assistants will code the video recordings for measures of nonverbal communication (e.g., gestures, familial expressions). This data will be analyzed through both qualitative and quantitative methods.
Measured: Measures will be collected from baseline through the end of intervention (week 4)
Secondary outcomes (4)
Quality of Life
The Quality of Life in Alzheimer's Dementia (QoL-AD) will be administered to participants with dementia and caregiver-participants to evaluate subjective quality of life. The QoL-AD is a 13-item questionnaire employing 4-point Likert scales. Higher scores indicate greater subjective quality of life.
Measured: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Well-Being
The WHO (Five) Well-Being Index will be administered to participants living with dementia and caregiver-participants to evaluate subjective wellbeing. The WHO (Five) is a 5-item questionnaire employing 6-point Likert scales.
Measured: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Caregiver Burden
The Short Zarit Burden Interview tool will be completed by caregiver-participants and will be used to evaluate subjective feelings of caregiver burden associated with being a caregiver for the person with dementia. The Short Zarit Burden Interview is a 6-item questionnaire that employs a 5-point Likert scale.
Measured: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Usability/Preference
System Usability Scale (SUS) will be administered to evaluate device usability/ease-of-use for both VR and Tablet-only conditions. The SUS is a 10-item questionnaire employing 5-point Likert scales.
Measured: Measure will be collected after each phase of the intervention (end of week 2 and week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study start17 Nov 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Age-Well NCE Inc., Canadian Institutes of Health Research (CIHR), Associated Medical Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06568211
- Sponsor's protocol ID
- 21-5701
- Other IDs
- 163902
- Acronym
- VRx@Home
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang LC, Yang YH. The Long-term Effects of Immersive Virtual Reality Reminiscence in People With Dementia: Longitudinal Observational Study. JMIR Serious Games. 2022 Jul 25;10(3):e36720. doi: 10.2196/36720.
PubMed 35877169Coelho T, Marques C, Moreira D, Soares M, Portugal P, Marques A, Ferreira AR, Martins S, Fernandes L. Promoting Reminiscences with Virtual Reality Headsets: A Pilot Study with People with Dementia. Int J Environ Res Public Health. 2020 Dec 12;17(24):9301. doi: 10.3390/ijerph17249301.
PubMed 33322679Appel L, Ali S, Narag T, Mozeson K, Pasat Z, Orchanian-Cheff A, Campos JL. Virtual reality to promote wellbeing in persons with dementia: A scoping review. J Rehabil Assist Technol Eng. 2021 Dec 21;8:20556683211053952. doi: 10.1177/20556683211053952. eCollection 2021 Jan-Dec.
PubMed 35024166Appel L, Appel E, Kisonas E, Lewis-Fung S, Pardini S, Rosenberg J, Appel J, Smith C. Evaluating the Impact of Virtual Reality on the Behavioral and Psychological Symptoms of Dementia and Quality of Life of Inpatients With Dementia in Acute Care: Randomized Controlled Trial (VRCT). J Med Internet Res. 2024 Jan 30;26:e51758. doi: 10.2196/51758.
PubMed 38289666Appel L, Appel E, Bogler O, Wiseman M, Cohen L, Ein N, Abrams HB, Campos JL. Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. Front Med (Lausanne). 2020 Jan 15;6:329. doi: 10.3389/fmed.2019.00329. eCollection 2019.
PubMed 32010701Saryazdi R, Appel L, Lewis-Fung S, Carsault LA, Qi D, Garcia-Giler E, Campos JL. VRx@Home protocol: A virtual reality at-home intervention for persons living with dementia and their care partners. BMJ Open. 2024 Dec 20;14(12):e085442. doi: 10.1136/bmjopen-2024-085442.
PubMed 39806619
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VRx@Home: A Virtual Reality At-Home Intervention for Persons Living With Dementia and Their Care Partners
- ClinicalTrials.gov ID
- NCT06568211
- Acronym / sponsor ID
- VRx@Home / 21-5701
- Conditions
- Dementia
- Keywords
- Virtual Reality, Tablet, Reminiscence, Verbal communication, Nonverbal communication, Interpersonal Relationship, Quality of Life, Well-Being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Age-Well NCE Inc., Canadian Institutes of Health Research (CIHR), Associated Medical Services
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 23 Aug 2024 (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 goal of the current study is to design and evaluate a virtual reality (VR) at-home intervention to facilitate communication between persons living with dementia (PLwD) and their family/friend care partners, and in turn improve their interpersonal relationships and quality of life. The project also aims to provide a direct comparison of an immersive VR system with non-immersive tablet-based technology.
PLwD and care partner interactions will be recorded during each of the following sessions and then used for the primary measure of verbal and non-verbal communication.
- Picture Book condition (baseline): PLwD and care partner view pictures together on photo album
- VR condition: PLwD watch 360 degree videos on a VR and the care partner watches the same content concurrently on a paired tablet
- Table-Only condition: PLwD and care partner watch 360 videos together on the tablet
Detailed description
Head Mounted VR headsets allow a person to transport to alternate realities such as visiting another country, attending a concert or a sporting event. The evidence to date suggests that VR experiences have positive impact on the well-being of individuals living with dementia. Most of this work however, has been in more formal settings whether it's long-term care or community programs, with trained formal care partners or researchers. Further, little work has explored specifically communication outcomes within the family dynamics.
After obtaining informed consent, participants will complete a Demographic and Health History questionnaire, and then will be scheduled for their first home visit. During this session, researcher will provide training on how to use the devices, how to video-record the study sessions, and how to complete study questionnaires through the supplied laptop. The PLwD and care partner will also view a picture book together while their interaction is being recorded through a video-conferencing software.
Participants will then begin the four weeks of intervention, where they will either be placed in the VR first intervention condition for the first two week or the Tablet-only first intervention condition (weeks 1 and 2), and then they will switch and receive the other device in the following two weeks (weeks 3 and 4). Participants will receive additional at-home training in-between two intervention phases. Irrespective of the condition, once a week participants will have a session with researcher over a video-conferencing software, where they watch a 20 mins video sequence that has a combination of 4 videos of different themes (animal, entertainment, travel, and sports) preselected for them. This is then followed by a short semi-structured interview asking participants about their preferences and experience. In addition, participants are asked to try the devices on their own and record their interactions.
In addition to the video recording of sessions which will be used for analyses of verbal and non-verbal communication, and interview data, participants will be asked to complete a set of questionnaires at baseline, and after each phase of the intervention. They will also be given a journal to note down any additional information they would like to share beyond those captures in interviews and questionnaires.
After completing the study, a final semi-structure interview will be conducted with participants to evaluate the overall feasibility and effectiveness of intervention. Study will complete with a final home visit to pick up devices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: VR first | Experimental | Device: Virtual Reality, Device: Tablet-OnlyThose assigned to Group A will be placed in the Virtual Reality (VR) intervention phase first. All participants will begin with a baseline picture book condition (week 0), and then those in Group A, will complete the VR intervention condition in the first two weeks (weeks 1 \& 2). After completing the two weeks of VR intervention, participating families will be asked to complete a set of standardized questionnaires. The following next two weeks (weeks 3 \& 4), participants will complete the Tablet-only intervention phase. At the end of this phase, participating families will again complete the same standardized questionnaires and will participate in a semi-structured interview about their experiences. Each session is expected to include 20 minutes of VR exposure. Each session will also be video-recorded for later analyses. |
| Group B: Tablet-only first | Experimental | Device: Virtual Reality, Device: Tablet-OnlyThose assigned to Group B will be placed in the Tablet-only intervention phase first. All participants will begin with a baseline picture book condition (week 0), and then those in Group B, will complete the Tablet-only condition in the first two weeks (weeks 1 \& 2). After completing the two weeks of Tablet-only intervention, participating families will be asked to complete a set of standardized questionnaires. The following next two weeks (weeks 3 \& 4), participants will complete the VR intervention phase. At the end of this phase, participating families will again complete the same standardized questionnaires and will participate in a semi-structured interview about their experiences. Each session is expected to include 20 minutes of VR exposure. Each session will also be video-recorded for later analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 RealityAlso: VR, HMDPersons living with dementia (PLwD) will view 360-degree videos using a commercially-available Virtual Reality (VR) head mounted display that has built-in speakers. While wearing the VR headset, PLwD-participant will be able to visually explore the virtual environments by turning their head to face different directions. Care partner-participants will take part in the VR experience concurrently by viewing a tablet that is connected to the VR headset through the \"screen mirroring\" function. | Device | Group A: VR first, Group B: Tablet-only first |
| Tablet-OnlyAlso: TabletPLwD and care partner will view 360-degree videos together on a commercially-available tablet that has built-in speakers. They will be able to visually explore the virtual environment using the touch screen (dragging the view around with their fingers). | Device | Group A: VR first, Group B: Tablet-only first |
Primary outcome
Quality of conversation and dyadic interactions (observations)
Time frame: Measures will be collected from baseline until the end of the intervention (week 4).
Trained research assistants will code the video recordings for the quality of participation, support, and engagement using the standardized Measure of Participation in Conversation for Dementia (focused on PLwD) and Measure of Support in Conversation for Dementia (focused on Care partner).
Quality of conversation and dyadic interactions (self-report)
Time frame: Measures will be collected from baseline until the end of the intervention (week 4).
Participating families will complete a communication questionnaire.
Verbal Communication
Time frame: Measures will be collected from baseline through the end of intervention (week 4)
Trained research assistants will code the video recordings for measures of verbal communication (e.g., utterance length, coherence, reminiscence). This data will be analyzed through both qualitative and quantitative methods.
Nonverbal Communication
Time frame: Measures will be collected from baseline through the end of intervention (week 4)
Trained research assistants will code the video recordings for measures of nonverbal communication (e.g., gestures, familial expressions). This data will be analyzed through both qualitative and quantitative methods.
4 secondary outcomes
Quality of Life
Time frame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Well-Being
Time frame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Caregiver Burden
Time frame: Measured at baseline, and after each phase of the intervention (end of week 2, and week 4)
Usability/Preference
Time frame: Measure will be collected after each phase of the intervention (end of week 2 and week 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 35877169Huang LC, Yang YH. The Long-term Effects of Immersive Virtual Reality Reminiscence in People With Dementia: Longitudinal Observational Study. JMIR Serious Games. 2022 Jul 25;10(3):e36720. doi: 10.2196/36720.
- Background: PubMed 33322679Coelho T, Marques C, Moreira D, Soares M, Portugal P, Marques A, Ferreira AR, Martins S, Fernandes L. Promoting Reminiscences with Virtual Reality Headsets: A Pilot Study with People with Dementia. Int J Environ Res Public Health. 2020 Dec 12;17(24):9301. doi: 10.3390/ijerph17249301.
- Background: PubMed 35024166Appel L, Ali S, Narag T, Mozeson K, Pasat Z, Orchanian-Cheff A, Campos JL. Virtual reality to promote wellbeing in persons with dementia: A scoping review. J Rehabil Assist Technol Eng. 2021 Dec 21;8:20556683211053952. doi: 10.1177/20556683211053952. eCollection 2021 Jan-Dec.
- Background: PubMed 38289666Appel L, Appel E, Kisonas E, Lewis-Fung S, Pardini S, Rosenberg J, Appel J, Smith C. Evaluating the Impact of Virtual Reality on the Behavioral and Psychological Symptoms of Dementia and Quality of Life of Inpatients With Dementia in Acute Care: Randomized Controlled Trial (VRCT). J Med Internet Res. 2024 Jan 30;26:e51758. doi: 10.2196/51758.
- Background: PubMed 32010701Appel L, Appel E, Bogler O, Wiseman M, Cohen L, Ein N, Abrams HB, Campos JL. Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. Front Med (Lausanne). 2020 Jan 15;6:329. doi: 10.3389/fmed.2019.00329. eCollection 2019.
- Derived from this study: PubMed 39806619Saryazdi R, Appel L, Lewis-Fung S, Carsault LA, Qi D, Garcia-Giler E, Campos JL. VRx@Home protocol: A virtual reality at-home intervention for persons living with dementia and their care partners. BMJ Open. 2024 Dec 20;14(12):e085442. doi: 10.1136/bmjopen-2024-085442.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Tablet-Only in people with Dementia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Apr 2025. 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of conversation and dyadic interactions (observations) (time frame: Measures will be collected from baseline until the end of the intervention (week 4).). 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 NCT06568211, which also lists 6 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 11 Apr 2025.