Clinical trial NCT06429215: 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
Official title: Preventing Cognitive Decline and Dementia Through an Innovative Immersive Virtual Reality and Telemedicine-based Multi-component Intervention: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subjective Cognitive Decline
Keywords: Subjective cognitive decline
Multi-component training
Non-pharmacological intervention
Virtual reality
Telemedicine
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2024-05-24
Enrollment: 75
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
measure: Cognitive functioning (2): change scores on the Visual Short-Term Memory Binding Test
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
measure: Cognitive functioning (3): change scores on the Spatial pattern separation test
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
Secondary outcomes:
measure: Transfer effect on self-perceived cognitive functioning: change scores on the Subjective Memory Complaints Questionnaire
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
measure: Intervention-induced changes in whole-brain functional connectivity
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
measure: Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
measure: Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
measure: Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale (AES)
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
measure: Transfer effect on quality of life and health status: Change scores on the Short Form-36 Health Survey
timeFrame: Baseline, post-intervention (around 6 weeks after baseline)
Other outcomes:
Locations:
city: Rome
country: Italy
facility: I.R.C.C.S Santa Lucia Foundation
state: Lazio
Study officials:
References: