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

I.R.C.C.S. Fondazione Santa Lucia

Status: Enrolling

Conditions: Subjective Cognitive Decline

Treatments: Device: Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control); Device: Multi-component Intervention (MC-I): VR Cognitive training and Psychoeducation on health and lifestyle; Device: Active control intervention (AC-I): VR Cognitive active control + Psychoeducation active control

Study type: Interventional

Funder types: Other

Identifiers

NCT06429215

PRIN 2022 PNRR P2022E3CZY

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups

Multi-component Intervention (MC-I)

Experimental group

Description:

VR cognitive training + Psychoeducation program

Treatment:

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

Cognitive-only intervention (CO-I)

Active Comparator group

Description:

VR Cognitive training + Psychoeducation active control

Treatment:

Device: Cognitive-only intervention (CO-I): VR Cognitive training (+ Psychoeducation active control)

Active control intervention (AC-I)

Active Comparator group

Description:

VR Cognitive active control + Psychoeducation active control

Treatment:

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