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

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

Interventions

DEVICE

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

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.

DEVICE

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

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

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.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-07-01

Primary Completion

2025-05-31

Completion

2025-12-31

Countries

• Italy

Study Locations