Alzheimer DiseaseCODDINCT07645638
Virtual Reality Cognitive Stimulation for Alzheimer's
A study testing Virtual reality in people with Alzheimer Disease and Memory Disorders, run by Universidad de Burgos at 1 site in Spain.
Trial summary
This study aims to evaluate whether immersive virtual reality (VR) can improve cognitive function and memory in patients with Alzheimer's disease. Twenty participants in Burgos, Spain, will engage in VR sessions that recreate scenes from 1960s Burgos, representing environments familiar from the participants' youth. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Memory Disorders
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2025to 20 Mar 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with mild cognitive impairment
- Aged 60 years or older.
- Resident or attending care at the Alzheimer's care center in Burgos.
- Capable of providing informed consent, either directly or through a legally authorized representative.
- Adequate vision and hearing (corrected if necessary) to engage with the VR experience.
- Able to tolerate wearing a VR headset for sessions of approximately 15-30 minutes.
Who cannot join
- Diagnosis of other neurodegenerative disorders (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis).
- History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
- Severe vision or hearing impairment that cannot be corrected (e.g., legal blindness).
- History of epilepsy, seizure disorders, or other conditions that may be aggravated by VR exposure.
- Active skin conditions or infections that prevent the use of a VR headset or EEG sensors.
- Participation in another interventional clinical trial within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Stimulation and Memory Enhancement Through Virtual Reality in Patients With Alzheimer's Disease: A Behavioral, Biometric, and Neurocognitive Assessment
This study aims to evaluate whether immersive virtual reality (VR) can improve cognitive function and memory in patients with Alzheimer's disease. Twenty participants in Burgos, Spain, will engage in VR sessions that recreate scenes from 1960s Burgos, representing environments familiar from the participants' youth. The effects of these VR-based cognitive stimulation sessions will be assessed through pre- and post-intervention evaluations, including behavioral observations, EEG monitoring of brain activity, and standardized neurocognitive tests (Montreal Cognitive Assessment, Clock-Drawing Test, and Verbal Fluency Test).
Read the detailed description
Introduction: Alzheimer's disease is a neurodegenerative condition characterized by progressive cognitive decline. Virtual reality (VR) technologies offer an innovative approach to cognitive stimulation in patients with this condition. This study will evaluate the impact of VR on memory and cognition improvement in patients with Alzheimer's disease in Burgos.
Objective: Evaluate the effectiveness of cognitive and memory stimulation through virtual reality experiences in patients with Alzheimer's disease, using behavioral analysis, biometric data (EEG), and neurocognitive testing.
Methodology: A total of 20 patients diagnosed with Alzheimer's disease at a specialized center in Burgos will be selected. The patients will be exposed to virtual reality scenarios recreating the city of Burgos in the 1960s, a period corresponding to their youth. Their cognitive and emotional status will be assessed before and after the sessions using neurocognitive tests, behavioral monitoring, and biometric data recording (EEG). Analyses of variance (ANOVA), analyses of covariance (ANCOVA), and multivariate analyses of variance (MANOVA) were perfomed
- Conditions
- Alzheimer Disease, Memory Disorders
- Being tested
- Virtual reality
- Keywords
- alzheimer disease, virtual reality, cognitive therapy, neuropsychological tests
- Medical subject headings
- Alzheimer Disease, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
The intervention consists of a series of immersive virtual reality (VR) sessions designed to provide cognitive stimulation for patients diagnosed with Alzheimer's disease. Participants in the experimental group will be exposed to VR environments that recreate the city of Burgos as it appeared in the 1960s, an era corresponding to their youth. These VR experiences will include familiar scenes, landmarks, and culturally relevant settings designed to evoke personal memories and enhance cognitive engagement.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The sample consisted of 33 people: 16 in the experimental group. Receives: Other: Virtual reality |
| Control group | No intervention | The sample consisted of 33 people: 17 in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function (Montreal Cognitive Assessment - MoCA)
Change in cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates multiple cognitive domains, including memory, attention, language, executive function, and visuospatial abilities. Total scores range from 0 to 30, with higher scores indicating better cognitive function. The change score will be calculated as the post-intervention score minus the baseline score.
Measured: Baseline and immediately after the last virtual reality session
Secondary outcomes (7)
Change in emotional well-being assessed with the Satisfaction With Life Scale (SWLS)
Change in emotional well-being will be assessed using the Satisfaction With Life Scale (SWLS). The SWLS is a 5-item scale that assesses global life satisfaction. Total scores range from 5 to 35, with higher scores indicating greater satisfaction with life and better emotional well-being. The change score will be calculated as the post-intervention score minus the baseline score.
Measured: Baseline and immediately after the last virtual reality session
Change in Verbal Fluency (Verbal Fluency Test)
Change in the number of words generated in a 60-second period, assessing language and cognitive processing speed.
Measured: Baseline and post-intervention.
Change in attention and processing speed
Attention, visual scanning, and processing speed will be assessed using the Trail Making Test Part A. The outcome will be the time required to complete the task. Lower completion times indicate better performance.
Measured: Baseline and immediately after the last virtual reality session
Change in executive function and cognitive flexibility assessed with the Trail Making Test Part B (TMT-B)
Executive function and cognitive flexibility will be assessed using the Trail Making Test Part B. The outcome will be the time required to complete the task. Lower completion times indicate better performance.
Measured: Baseline and immediately after the last virtual reality session
Change in positive affect assessed with the Positive and Negative Affect Schedule Short Form (PANAS-S)
Positive affect will be assessed using the positive affect subscale of the Positive and Negative Affect Schedule Short Form (PANAS-S). Higher scores indicate greater positive affect.
Measured: Baseline and immediately after the last virtual reality session.
Change in negative affect assessed with the Positive and Negative Affect Schedule Short Form (PANAS-S)
Negative affect will be assessed using the negative affect subscale of the Positive and Negative Affect Schedule Short Form (PANAS-S). Higher scores indicate greater negative affect.
Measured: Baseline and immediately after the last virtual reality session
Immediate emotional response assessed with an Emotional Visual Analog Scale
Immediate emotional response will be assessed after each intervention session using an Emotional Visual Analog Scale ranging from 0 to 10, where higher scores indicate a more positive emotional state.
Measured: Baseline and immediately after the last virtual reality session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start8 Jan 2025
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies 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
- Model description
- This is a experimental design with non-equivalent groups (pretest-posttest) carried out in a more realistic setting, where the dependent variables of interest were manipulated by the researcher under controlled conditions.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Burgos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07645638
- Sponsor's protocol ID
- CODDI
- Acronym
- CODDI
- Status last verified
- May 2026
- First submitted
- 29 May 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Redmond LW. Spiritual coping tools of religious victims of childhood sexual abuse. J Pastoral Care Counsel. 2014 Mar-Jun;68(1-2):3.
PubMed 25241481Maggio MG, Latella D, Maresca G, Sciarrone F, Manuli A, Naro A, De Luca R, Calabro RS. Virtual Reality and Cognitive Rehabilitation in People With Stroke: An Overview. J Neurosci Nurs. 2019 Apr;51(2):101-105. doi: 10.1097/JNN.0000000000000423.
PubMed 30649091Zhang J, Wu M, Li J, Song W, Lin X, Zhu L. Effects of virtual reality-based rehabilitation on cognitive function and mood in multiple sclerosis: A systematic review and meta-analysis of randomized controlled trials. Mult Scler Relat Disord. 2024 Jul;87:105643. doi: 10.1016/j.msard.2024.105643. Epub 2024 May 9.
PubMed 38735202Garcia-Betances RI, Jimenez-Mixco V, Arredondo MT, Cabrera-Umpierrez MF. Using virtual reality for cognitive training of the elderly. Am J Alzheimers Dis Other Demen. 2015 Feb;30(1):49-54. doi: 10.1177/1533317514545866. Epub 2014 Aug 7.
PubMed 25107931Wang Z, Cao Y, Zhang K, Guo Z, Liu Y, Zhou P, Liu Z, Lu X. Gold nanoparticles alleviates the lipopolysaccharide-induced intestinal epithelial barrier dysfunction. Bioengineered. 2021 Dec;12(1):6472-6483. doi: 10.1080/21655979.2021.1972782.
PubMed 34523392
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Stimulation and Memory Enhancement Through Virtual Reality in Patients With Alzheimer's Disease: A Behavioral, Biometric, and Neurocognitive Assessment
- ClinicalTrials.gov ID
- NCT07645638
- Acronym / sponsor ID
- CODDI / CODDI
- Conditions
- Alzheimer Disease, Memory Disorders
- Keywords
- alzheimer disease, virtual reality, cognitive therapy, neuropsychological tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Universidad de BurgosUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 12 Jun 2026 (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 study aims to evaluate whether immersive virtual reality (VR) can improve cognitive function and memory in patients with Alzheimer's disease. Twenty participants in Burgos, Spain, will engage in VR sessions that recreate scenes from 1960s Burgos, representing environments familiar from the participants' youth. The effects of these VR-based cognitive stimulation sessions will be assessed through pre- and post-intervention evaluations, including behavioral observations, EEG monitoring of brain activity, and standardized neurocognitive tests (Montreal Cognitive Assessment, Clock-Drawing Test, and Verbal Fluency Test).
Detailed description
Introduction: Alzheimer's disease is a neurodegenerative condition characterized by progressive cognitive decline. Virtual reality (VR) technologies offer an innovative approach to cognitive stimulation in patients with this condition. This study will evaluate the impact of VR on memory and cognition improvement in patients with Alzheimer's disease in Burgos.
Objective: Evaluate the effectiveness of cognitive and memory stimulation through virtual reality experiences in patients with Alzheimer's disease, using behavioral analysis, biometric data (EEG), and neurocognitive testing.
Methodology: A total of 20 patients diagnosed with Alzheimer's disease at a specialized center in Burgos will be selected. The patients will be exposed to virtual reality scenarios recreating the city of Burgos in the 1960s, a period corresponding to their youth. Their cognitive and emotional status will be assessed before and after the sessions using neurocognitive tests, behavioral monitoring, and biometric data recording (EEG). Analyses of variance (ANOVA), analyses of covariance (ANCOVA), and multivariate analyses of variance (MANOVA) were perfomed
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a experimental design with non-equivalent groups (pretest-posttest) carried out in a more realistic setting, where the dependent variables of interest were manipulated by the researcher under controlled conditions.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Virtual realityThe sample consisted of 33 people: 16 in the experimental group. |
| Control group | No intervention | –The sample consisted of 33 people: 17 in the control group. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with mild cognitive impairment
- Aged 60 years or older.
- Resident or attending care at the Alzheimer's care center in Burgos.
- Capable of providing informed consent, either directly or through a legally authorized representative.
- Adequate vision and hearing (corrected if necessary) to engage with the VR experience.
Key exclusion criteria (6 listed)
- Diagnosis of other neurodegenerative disorders (e.g., Parkinson's disease, Huntington's disease, multiple sclerosis).
- History of severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
- Severe vision or hearing impairment that cannot be corrected (e.g., legal blindness).
- History of epilepsy, seizure disorders, or other conditions that may be aggravated by VR exposure.
- Active skin conditions or infections that prevent the use of a VR headset or EEG sensors.
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 realityThe intervention consists of a series of immersive virtual reality (VR) sessions designed to provide cognitive stimulation for patients diagnosed with Alzheimer's disease. Participants in the experimental group will be exposed to VR environments that recreate the city of Burgos as it appeared in the 1960s, an era corresponding to their youth. These VR experiences will include familiar scenes, landmarks, and culturally relevant settings designed to evoke personal memories and enhance cognitive engagement. | Other | Experimental group |
Primary outcome
Change in Cognitive Function (Montreal Cognitive Assessment - MoCA)
Time frame: Baseline and immediately after the last virtual reality session
Change in cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates multiple cognitive domains, including memory, attention, language, executive function, and visuospatial abilities. Total scores range from 0 to 30, with higher scores indicating better cognitive function. The change score will be calculated as the post-intervention score minus the baseline score.
7 secondary outcomes
Change in emotional well-being assessed with the Satisfaction With Life Scale (SWLS)
Time frame: Baseline and immediately after the last virtual reality session
Change in Verbal Fluency (Verbal Fluency Test)
Time frame: Baseline and post-intervention.
Change in attention and processing speed
Time frame: Baseline and immediately after the last virtual reality session
Change in executive function and cognitive flexibility assessed with the Trail Making Test Part B (TMT-B)
Time frame: Baseline and immediately after the last virtual reality session
Change in positive affect assessed with the Positive and Negative Affect Schedule Short Form (PANAS-S)
Time frame: Baseline and immediately after the last virtual reality session.
Change in negative affect assessed with the Positive and Negative Affect Schedule Short Form (PANAS-S)
Time frame: Baseline and immediately after the last virtual reality session
Immediate emotional response assessed with an Emotional Visual Analog Scale
Time frame: Baseline and immediately after the last virtual reality session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 25241481Redmond LW. Spiritual coping tools of religious victims of childhood sexual abuse. J Pastoral Care Counsel. 2014 Mar-Jun;68(1-2):3.
- Background: PubMed 30649091Maggio MG, Latella D, Maresca G, Sciarrone F, Manuli A, Naro A, De Luca R, Calabro RS. Virtual Reality and Cognitive Rehabilitation in People With Stroke: An Overview. J Neurosci Nurs. 2019 Apr;51(2):101-105. doi: 10.1097/JNN.0000000000000423.
- Background: PubMed 38735202Zhang J, Wu M, Li J, Song W, Lin X, Zhu L. Effects of virtual reality-based rehabilitation on cognitive function and mood in multiple sclerosis: A systematic review and meta-analysis of randomized controlled trials. Mult Scler Relat Disord. 2024 Jul;87:105643. doi: 10.1016/j.msard.2024.105643. Epub 2024 May 9.
- Background: PubMed 25107931Garcia-Betances RI, Jimenez-Mixco V, Arredondo MT, Cabrera-Umpierrez MF. Using virtual reality for cognitive training of the elderly. Am J Alzheimers Dis Other Demen. 2015 Feb;30(1):49-54. doi: 10.1177/1533317514545866. Epub 2014 Aug 7.
- Background: PubMed 34523392Wang Z, Cao Y, Zhang K, Guo Z, Liu Y, Zhou P, Liu Z, Lu X. Gold nanoparticles alleviates the lipopolysaccharide-induced intestinal epithelial barrier dysfunction. Bioengineered. 2021 Dec;12(1):6472-6483. doi: 10.1080/21655979.2021.1972782.
- 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 in people with Alzheimer Disease and Memory Disorders, run by Universidad de Burgos at 1 site in Spain.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jun 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Cognitive Function (Montreal Cognitive Assessment - MoCA) (time frame: Baseline and immediately after the last virtual reality session). 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 NCT07645638, which also lists 5 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 12 Jun 2026.