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

NCT06429215 | Recruiting

• 1 other identifier: PRIN 2022 PNRR P2022E3CZY
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Subjective cognitive decline; Multi-component training; Non-pharmacological intervention; Virtual reality; Telemedicine

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  Baseline, post-intervention (around 6 weeks after baseline)

• Intervention-induced changes in whole-brain functional connectivity

  Baseline, post-intervention (around 6 weeks after baseline)

• Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale

  Baseline, post-intervention (around 6 weeks after baseline)

• Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory

  Baseline, post-intervention (around 6 weeks after baseline)

• Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale (AES)

  Baseline, post-intervention (around 6 weeks after baseline)

Study Arms (3)

Multi-component Intervention (MC-I)

EXPERIMENTAL

VR cognitive training + Psychoeducation program

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

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

Device: Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control

Interventions

Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle DEVICE

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.

Multi-component Intervention (MC-I)

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.

Cognitive-only intervention (CO-I)

Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control DEVICE

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.

Active control intervention (AC-I)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-perceived decline in cognition compared to five years ago
• Lack of objective cognitive impairment.

You may not qualify if:

• 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;

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

I.R.C.C.S Santa Lucia Foundation

Rome, Lazio, 00179, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 40718565 DERIVED

Central Study Contacts

Maria Stefania De Simone, Dr

CONTACT

(+39) 06-51501189; ms.desimone@hsantalucia.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 24, 2024
• Study Start: July 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

IT (1)