Subjective Cognitive DeclineSCD-ReCODEDNCT06429215
REducing the Risk of COgnitive DEcline ad Dementia in Patients With Subjective Cognitive Decline Through an Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: the SCD-ReCODED Study
A study testing Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle in people with Subjective Cognitive Decline, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial summary
Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjective Cognitive Decline
- What is being tested?
- Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2024to Dec 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-perceived decline in cognition compared to five years ago
- Lack of objective cognitive impairment.
Who cannot join
- Clinically significant depression and anxiety;
- Psychiatric disorders;
- Unstable medical conditions.
- Severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
- Dizziness or epilepsy history;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
I.R.C.C.S Santa Lucia Foundation
Rome, Lazio, 00179
Maria Stefania De Simone, Dr, +39 0651501189, ms.desimone@hsantalucia.it
About this study
Official title: Preventing Cognitive Decline and Dementia Through an Innovative Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: a Randomized Controlled Trial
Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. To date, the lack of effective disease-modifying treatments, along with the reliable identification of modifiable lifestyle risk factors (e.g., cognitive activity, dietary habits, physical exercise), have led to growing interest to invest in non-pharmacological interventions that may reduce the prevalence and incidence of dementia and cognitive decline in older adults. In this framework, the aim of this project is to evaluate the efficacy of an Immersive Virtual Reality (IVR) and telemedicine-based multi-component intervention, combining cognitive training and a health and lifestyle education program, for preventing cognitive decline and dementia in at-risk individuals (i.e., SCD). For this purpose, a randomized, double-blinded controlled trial (RCT) will be conducted on seventy-five eligible individuals with SCD, who will be randomly assigned to one of three conditions: (a) multi-component intervention (MC-I), including SCD-tailored cognitive IVR training plus a health and lifestyle education program, (b) cognitive-only intervention (CO-I), including the SCD-tailored cognitive IVR training plus an active control for the education program, and (c) active control intervention (AC-I) for both cognitive training and education program. Intervention will be provided in 20 at-home sessions (4 sessions/week, each lasting about 30 minutes) over a period of 5 weeks. Outcome measures include clinical, neuropsychological, behavioural and neuroimaging data that will be collected before and immediately after intervention in order to detect potentially intervention-induced changes in objective cognitive functioning (primary outcome), subjective cognitive functioning, mood, quality of life and brain connectivity (secondary outcome). Users' compliance with IVR and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy.
- Conditions
- Subjective Cognitive Decline
- Being tested
- Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle, Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control), Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control
- Keywords
- Subjective cognitive decline, Multi-component training, Non-pharmacological intervention, Virtual reality, Telemedicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyleDevice
In a period of 5 consecutive weeks, participants will receive:
- an interactive immersive virtual reality cognitive training for 30 minutes, 3 days per week. It consists in different tasks implemented in virtual real-like scenarios of daily living situations that target the following cognitive processes: long-term associative memory, relational binding, spatial pattern separation and pattern completion;
- an interactive immersive virtual reality health and lifestyle education program for 30 minutes, 1 day per week. It consists in 360° videos aimed at advancing awareness and knowledge of the various health conditions associated with an increased risk of cognitive decline and dementia and helping participants to develop a healthier lifestyle.
Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control)Device
In a period of 5 consecutive weeks, participants will receive:
- the interactive immersive virtual reality cognitive training as described in the MC-I condition, for about 30 minutes, 3 days per week;
- an active control of the immersive virtual reality psychoeducation program for 30 minutes, 1 day per week.
Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active controlDevice
In a period of 5 consecutive weeks, participants will receive:
- an active control of the immersive virtual reality cognitive training (participants will be requested to virtually carry out daily actions, in the same setting as those performed in cognitive immersive VR training, but they will follow prearranged instructions requiring very low cognitive demands) for about 30 minutes, 3 days per week;
- an active control of the immersive virtual reality psychoeducation program for about 30 minutes, 1 day per week.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component Intervention (MC-I) | Experimental | VR cognitive training + Psychoeducation program Receives: Device: Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle |
| Cognitive-only intervention (CO-I) | Active comparator | VR Cognitive training + Psychoeducation active control Receives: Device: Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control) |
| Active control intervention (AC-I) | Active comparator | VR Cognitive active control + Psychoeducation active control Receives: Device: Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam
The Face-Name Associative Memory Exam (short form - FNAME12) is an associative long-term memory task that requires the participant to learn and retrieve 12 novel face-name and face-occupation pairs. It consists of two learning phases, followed by an immediate cued recall and a 30-min delayed recall and recognition trial. For each trial, scores range from 0 to 12, where higher scores indicate better memory performance.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Cognitive functioning (2): change scores on the Visual Short-Term Memory Binding Test
The Visual Short-Term Memory Binding Test is a recognition task based on a change detection paradigm for arrays of stimuli presented on a computer screen. Two conditions are investigated, that is, a shape-only condition as the first and a shape-color condition as the second. In both conditions, participants are asked to remember visual arrays of two or three black polygons (in the shape-only condition) or colored polygons (in the shape-color condition) presented for 2 s (study phase). For each condition, scores range from 0 to 32, where higher scores indicate better memory performance.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Cognitive functioning (3): change scores on the Spatial pattern separation test
The Spatial pattern separation test assesses the ability to differentiate partially overlapping patterns of activation in order to retrieve one pattern as separate from others that are similar. Specifically, it consists of 36 trials, in which the participant is required to learn the location of a grey circle on a sceen; then the participant is required to recognize the position of the previously-learned grey circle with respect to a foil located either to the left or the right of the target. Scores range from 0 to 36, where higher scores indicate better memory performance.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Secondary outcomes (6)
Transfer effect on self-perceived cognitive functioning: change scores on the Subjective Memory Complaints Questionnaire
The Subjective Memory Complaints Questionnaire assesses the subjective experience of memory decline. It consists of two sections. Part I provides a global evaluation of memory concerns responses to four general questions (4 items); Part II provides an evaluation of memory concerns in daily life (27 items). For each of the 31 items, participants are asked to respond on a 4-point Likert scale (1 = No, it does not happen to me; 2 = Sometimes, but it does not worry me; 3 = Yes and it worries me; 4 = Yes and it constitutes a problemin at least one area ofmy life, e.g., work, family, leisure, relationships). Scores range from 31 to 124. Higher scores are indicative of more serious memory complaints.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Intervention-induced changes in whole-brain functional connectivity
Connectomics changes after intervention will be investigated between pairs of regions of the whole brain (with particular interest in areas mainly involved in training-related cognitive processes) and in the global and local topological properties of large-scale networks through graph theoretical approach.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale
It is a brief self-report questionnaire in which participants are asked to respond to the 30 questions by answering yes or no in reference to how they felt on the day of administration. Scores range from 0 to 30, where higher scores indicate higher depression.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory
It is a brief self-report questionnaire to measure the presence and severity of current symptoms of anxiety and a generalized propensity to be anxious. There are two subscales within this measure: the State Anxiety Scale (S-Anxiety), which evaluates the current state of anxiety, and the Trait Anxiety Scale (T-Anxiety), which evaluates relatively stable aspects of "anxiety proneness". Range of scores for each subtest is 20-80, with higher scores indicating greater anxiety.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale (AES)
The Apathy Evaluation Scale is a four-point Likert-Scale measure, composed of 18 items that assess and quantify emotional, behavioural and cognitive aspects of apathy. Every item is rated on a four-point response scale (0 = not at all true/characteristic to 3 = very much true/characteristic). Higher scores indicate more severe apathy.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on quality of life and health status: Change scores on the Short Form-36 Health Survey
The 36-Item Health Survey taps eight health concepts, including physical functioning, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Scores range from 0 to 100, where higher scores define a more favorable health state.
Measured: Baseline, post-intervention (around 6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jul 2024
- Primary completionMay 2025 (estimated)
- Study completionDec 2025 (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 Subjective Cognitive DeclineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Stefania De Simone, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429215
- Sponsor's protocol ID
- PRIN 2022 PNRR P2022E3CZY
- Acronym
- SCD-ReCODED
- Status last verified
- Sep 2024
- First submitted
- 10 May 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
De Simone MS, Zabberoni S, Costa A, Tenaglia E, Tieri G. The effects of an immersive virtual reality and telemedicine-based multi-component intervention in individuals with subjective cognitive decline: study protocol of a randomized controlled trial. Front Psychol. 2025 Jul 11;16:1591239. doi: 10.3389/fpsyg.2025.1591239. eCollection 2025.
PubMed 40718565
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Cognitive Decline and Dementia Through an Innovative Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06429215
- Acronym / sponsor ID
- SCD-ReCODED / PRIN 2022 PNRR P2022E3CZY
- Conditions
- Subjective Cognitive Decline
- Keywords
- Subjective cognitive decline, Multi-component training, Non-pharmacological intervention, Virtual reality, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 May 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.
Older adults with subjective cognitive decline (SCD) are at high risk of developing dementia and frequently experience subclinical symptoms (e.g., anxiety, depression) which are themselves associated with dementia and cognitive decline risk. To date, the lack of effective disease-modifying treatments, along with the reliable identification of modifiable lifestyle risk factors (e.g., cognitive activity, dietary habits, physical exercise), have led to growing interest to invest in non-pharmacological interventions that may reduce the prevalence and incidence of dementia and cognitive decline in older adults. In this framework, the aim of this project is to evaluate the efficacy of an Immersive Virtual Reality (IVR) and telemedicine-based multi-component intervention, combining cognitive training and a health and lifestyle education program, for preventing cognitive decline and dementia in at-risk individuals (i.e., SCD). For this purpose, a randomized, double-blinded controlled trial (RCT) will be conducted on seventy-five eligible individuals with SCD, who will be randomly assigned to one of three conditions: (a) multi-component intervention (MC-I), including SCD-tailored cognitive IVR training plus a health and lifestyle education program, (b) cognitive-only intervention (CO-I), including the SCD-tailored cognitive IVR training plus an active control for the education program, and (c) active control intervention (AC-I) for both cognitive training and education program. Intervention will be provided in 20 at-home sessions (4 sessions/week, each lasting about 30 minutes) over a period of 5 weeks. Outcome measures include clinical, neuropsychological, behavioural and neuroimaging data that will be collected before and immediately after intervention in order to detect potentially intervention-induced changes in objective cognitive functioning (primary outcome), subjective cognitive functioning, mood, quality of life and brain connectivity (secondary outcome). Users' compliance with IVR and telemedicine approach will be also evaluated, as well as individuals' factors affecting training efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multi-component Intervention (MC-I) | Experimental | Device: Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyleVR cognitive training + Psychoeducation program |
| Cognitive-only intervention (CO-I) | Active comparator | Device: Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control)VR Cognitive training + Psychoeducation active control |
| Active control intervention (AC-I) | Active comparator | Device: Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active controlVR Cognitive active control + Psychoeducation active control |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self-perceived decline in cognition compared to five years ago
- Lack of objective cognitive impairment.
Key exclusion criteria (5 listed)
- Clinically significant depression and anxiety;
- Psychiatric disorders;
- Unstable medical conditions.
- Severe visual, auditory, verbal or physical impairments interfere with communication, command compliance, and strategy execution
- Dizziness or epilepsy history;
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 |
|---|---|---|
| Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyleIn a period of 5 consecutive weeks, participants will receive: * an interactive immersive virtual reality cognitive training for 30 minutes, 3 days per week. It consists in different tasks implemented in virtual real-like scenarios of daily living situations that target the following cognitive processes: long-term associative memory, relational binding, spatial pattern separation and pattern completion; * an interactive immersive virtual reality health and lifestyle education program for 30 minutes, 1 day per week. It consists in 360° videos aimed at advancing awareness and knowledge of the various health conditions associated with an increased risk of cognitive decline and dementia and helping participants to develop a healthier lifestyle. | Device | Multi-component Intervention (MC-I) |
| Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control)In a period of 5 consecutive weeks, participants will receive: * the interactive immersive virtual reality cognitive training as described in the MC-I condition, for about 30 minutes, 3 days per week; * an active control of the immersive virtual reality psychoeducation program for 30 minutes, 1 day per week. | Device | Cognitive-only intervention (CO-I) |
| Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active controlIn a period of 5 consecutive weeks, participants will receive: * an active control of the immersive virtual reality cognitive training (participants will be requested to virtually carry out daily actions, in the same setting as those performed in cognitive immersive VR training, but they will follow prearranged instructions requiring very low cognitive demands) for about 30 minutes, 3 days per week; * an active control of the immersive virtual reality psychoeducation program for about 30 minutes, 1 day per week. | Device | Active control intervention (AC-I) |
Primary outcome
Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
The Face-Name Associative Memory Exam (short form - FNAME12) is an associative long-term memory task that requires the participant to learn and retrieve 12 novel face-name and face-occupation pairs. It consists of two learning phases, followed by an immediate cued recall and a 30-min delayed recall and recognition trial. For each trial, scores range from 0 to 12, where higher scores indicate better memory performance.
Cognitive functioning (2): change scores on the Visual Short-Term Memory Binding Test
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
The Visual Short-Term Memory Binding Test is a recognition task based on a change detection paradigm for arrays of stimuli presented on a computer screen. Two conditions are investigated, that is, a shape-only condition as the first and a shape-color condition as the second. In both conditions, participants are asked to remember visual arrays of two or three black polygons (in the shape-only condition) or colored polygons (in the shape-color condition) presented for 2 s (study phase). For each condition, scores range from 0 to 32, where higher scores indicate better memory performance.
Cognitive functioning (3): change scores on the Spatial pattern separation test
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
The Spatial pattern separation test assesses the ability to differentiate partially overlapping patterns of activation in order to retrieve one pattern as separate from others that are similar. Specifically, it consists of 36 trials, in which the participant is required to learn the location of a grey circle on a sceen; then the participant is required to recognize the position of the previously-learned grey circle with respect to a foil located either to the left or the right of the target. Scores range from 0 to 36, where higher scores indicate better memory performance.
6 secondary outcomes
Transfer effect on self-perceived cognitive functioning: change scores on the Subjective Memory Complaints Questionnaire
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
Intervention-induced changes in whole-brain functional connectivity
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale (AES)
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
Transfer effect on quality of life and health status: Change scores on the Short Form-36 Health Survey
Time frame: Baseline, post-intervention (around 6 weeks after baseline)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 40718565De Simone MS, Zabberoni S, Costa A, Tenaglia E, Tieri G. The effects of an immersive virtual reality and telemedicine-based multi-component intervention in individuals with subjective cognitive decline: study protocol of a randomized controlled trial. Front Psychol. 2025 Jul 11;16:1591239. doi: 10.3389/fpsyg.2025.1591239. eCollection 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle in people with Subjective Cognitive Decline, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
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 2 inclusion and 5 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 1 Oct 2024. 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 Italy. 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 Maria Stefania De Simone, Dr ((+39) 06-51501189, ms.desimone@hsantalucia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam (time frame: Baseline, post-intervention (around 6 weeks after baseline)). 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 NCT06429215, 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 1 Oct 2024.