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

Not Applicable

Recruiting

• Conditions: Subjective Cognitive Decline

• Registration Number: NCT06429215
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-20
• Study First Posted: 2024-05-24
• Study Start: 2024-07-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive functioning (1): change scores on the Face-Name Associative Memory Exam	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Transfer effect on self-perceived cognitive functioning: change scores on the Subjective Memory Complaints Questionnaire	Baseline, post-intervention (around 6 weeks after baseline)	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.
Intervention-induced changes in whole-brain functional connectivity	Baseline, post-intervention (around 6 weeks after baseline)	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.
Transfer effect on mood (1): change scores on the 30-item Geriatric Depression Scale	Baseline, post-intervention (around 6 weeks after baseline)	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.
Transfer effect on mood (2): change scores on the State-Trait Anxiety Inventory	Baseline, post-intervention (around 6 weeks after baseline)	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.
Transfer effect on mood (3): change scores on the 18-item Apathy Evaluation Scale (AES)	Baseline, post-intervention (around 6 weeks after baseline)	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.
Transfer effect on quality of life and health status: Change scores on the Short Form-36 Health Survey	Baseline, post-intervention (around 6 weeks after baseline)	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.

Trial Locations

Locations (1)

I.R.C.C.S Santa Lucia Foundation; 🇮🇹 Rome, Lazio, Italy