Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429215
Status:
RECRUITING
Last Update Posted:
2024-05-24
First Post:
2024-05-10
Brief Title:
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
Sponsor:
IRCCS Fondazione Santa Lucia
Organization:
IRCCS Fondazione Santa Lucia
Study Overview
Official Title:
Preventing Cognitive Decline and Dementia Through an Innovative Immersive Virtual Reality and Telemedicine-based Multi-component Intervention a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCD-ReCODED
Brief Summary:
Older adults with subjective cognitive decline SCD are at high risk of developing dementia and frequently experience subclinical symptoms eg 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 eg 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 ie 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 sessionsweek 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None