Ignite Creation Date:
2024-05-06 @ 4:08 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889560
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2021-05-07
Brief Title:
Home-based Cognitive Treatment and Cognitive Impairment
Sponsor:
IRCCS National Neurological Institute C Mondino Foundation
Organization:
IRCCS National Neurological Institute C Mondino Foundation
Study Overview
Official Title:
Home-based Cognitive Treatment of Early Stages of Cognitive Impairment in Neurodegenerative Diseases Home CoRe
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The prevalence of neurodegenerative diseases is expected to increase over the next years in parallel with the aging of the world population Therefore it is important to identify new methods to prevent delay or stop the neurodegenerative waterfall responsible for dementia conversion To date there is no fully proven pharmacological treatment for cognitive impairment and the available pharmacological treatments have limited efficacy because consist in symptomatic drugs with adverse side effects On this point non-pharmacological intervention may represent adjunctive therapy to medications in order to prevent or delay the onset of the cognitive deficits or dementia Recently we evaluated the effectiveness of a computerized cognitive training CoRe in patients with early cognitive impairment The main goal of the present protocol is to evaluate the efficacy of the home-based version of CoRe Home CoRe To this end mild dementia or early cognitive impairment and persons with Subjective Cognitive Impairment SCI are enrolled and randomly assigned to the experimental group Home CoRe or control group CoRe All patients are evaluated before T0 and after T1 treatment with an exhaustive neuropsychological assessment Furthermore follow-up visits are scheduled 6 months T2 and 12 months T3 after the end of the treatment
Detailed Description:
Non-pharmacological intervention may represent adjunctive therapy to medications in order to delay the onset of the cognitive deficits or dementia Moreover increasing evidence suggests that environmental and lifestyle factors education cognitive engagement experience impact on cognitive functions and brain plasticity during the lifetime and also during aging These modifiable factors moderate differences in cognitive aging and are protective for the development of dementia
Among non-pharmacological approaches previous studies observed a positive effect of Cognitive Training CT both in healthy elderly people and patients in the early stage of neurodegenerative diseases Moreover the advances in the development of Information Communication Technologies ICT has prompted the possibility to develop computer-based solution for the training of cognitive functions being able to overcome traditional-training advantages However some issue remain unresolved and larger randomized controlled trials are necessary to examine long-term CT effects due to the lack of longitudinal studies Our previous data demonstrated that CT program with CoRe software is safe and effective on cognition in patient with Parkinson Disease-Mild Cognitive Impairment in the attempt of briefly stabilizing cognitive decline delaying the downward trajectory The same pattern of findings resulted when using CoRe in patients with Mild Cognitive Impairment MCI and mild Alzheimers Disease AD Among ICT advantages there is the fact that they offer the possibility to develop patient tailored interventions that can be easily delivered not only in-person but also remotely at patients homes It means that they could simplify the therapists work in terms of the planning design and management of the cognitive intervention also outside from the clinical setting However some concerns have slowed the integration of home-based interventions into clinical practice such as the fact that people with advanced age or cognitive deficit might have poor computer skills and difficulties managing technological devices on their own Thus the overall efficacy of home-based CT programs is still under debate
In this frame the primary goal of this single-blind randomized controlled trial is to assess whether a home-based CT Home CoRe could offer comparable effects non-inferiority trial to those of an in-person CT CoRe A secondary goal is to follow these effects with respect to the evolution of cognitive decline These two interventions are evaluated also in terms of treatment adherence
Both treatment protocols consist of 18 sessions 3 sessionweek 45 minutesday of CT with CoRe vs HomeCoRe software training memory and logical-executive functions
Patients with mild dementia early cognitive impairment ie MCI and vascular cognitive impairment VCI and SCI are recruited from NeuropsychologyAlzheimers Disease Assessment Unit and Neurorehabilitation Unit of IRCCS Mondino Foundation Patients diagnosis is formulated on the basis of a comprehensive neuropsychological evaluation baseline cognitive assessment - T0 according to the guidelines presented in the literature The following standardized tests assessing different domains are used
global cognitive function Mini-Mental State Examination MMSE and Montreal Montreal Overall Cognitive Assessment MoCA
memory verbal Verbal Span Digit Span and spatial Corsis blocktapping test - CBTT span verbal long-term memory Logical Memory Test immediate and delayed recall Reys 15-word test immediate and delayed recall spatial long-term memory Rey Complex Figure delayed recall - RCF-dr
logical-executive functions non-verbal reasoning Ravens Matrices 1947 - RM47 frontal functionality Frontal Assessment Battery - FAB semantic fluency animals fruits car brands phonological fluency FAS
attention visual selective attention Attentive Matrices simple speed processing and complex attention Trail Making Test parts A - TMT A and part B - TMT B
visuospatial abilities constructive apraxia Rey Complex Figure copy - RCF-copy
The same battery is also used at follow-up visits parallel versions are applied when available verbal long-term memory tests in order to avoid the learning effect All the test scores are corrected for age sex and education and compared with the values available for the Italian population
At the baseline the cognitive reserve is assessed using Cognitive Reserve Index questionnaire CRIq The patients functional status is assessed using Activities of Daily Living ADL and Instrumental Activities of Daily Living IADL at the baseline and at the last follow-up visit after one year T3 Moreover mood is assessed using the Beck Depression Inventory BDI at the baseline and at the follow-up visits T1 T2 and T3 while quality of life were assessed using the 36-Item Short Form Health Survey questionnaire SF-36 at the baseline and at the follow-up visits six months T2 and one year T3 after training Subjective evaluation of intervention success is also considered by means of the Patient Global Impression of Change PGIC and the Patients Reported Outcome Measures PROMS administered at T0 and T1 Treatment adherence is evaluated considering the number of CT sessions carried out
All the patients recruited undergo baseline cognitive assessment T0 Patients who met the inclusion and exclusion criteria are enrolled and randomly assigned to the experimental group Home CoRe or control group CoRe
Among non-pharmacological approaches previous studies observed a positive effect of Cognitive Training CT both in healthy elderly people and patients in the early stage of neurodegenerative diseases Moreover the advances in the development of Information Communication Technologies ICT has prompted the possibility to develop computer-based solution for the training of cognitive functions being able to overcome traditional-training advantages However some issue remain unresolved and larger randomized controlled trials are necessary to examine long-term CT effects due to the lack of longitudinal studies Our previous data demonstrated that CT program with CoRe software is safe and effective on cognition in patient with Parkinson Disease-Mild Cognitive Impairment in the attempt of briefly stabilizing cognitive decline delaying the downward trajectory The same pattern of findings resulted when using CoRe in patients with Mild Cognitive Impairment MCI and mild Alzheimers Disease AD Among ICT advantages there is the fact that they offer the possibility to develop patient tailored interventions that can be easily delivered not only in-person but also remotely at patients homes It means that they could simplify the therapists work in terms of the planning design and management of the cognitive intervention also outside from the clinical setting However some concerns have slowed the integration of home-based interventions into clinical practice such as the fact that people with advanced age or cognitive deficit might have poor computer skills and difficulties managing technological devices on their own Thus the overall efficacy of home-based CT programs is still under debate
In this frame the primary goal of this single-blind randomized controlled trial is to assess whether a home-based CT Home CoRe could offer comparable effects non-inferiority trial to those of an in-person CT CoRe A secondary goal is to follow these effects with respect to the evolution of cognitive decline These two interventions are evaluated also in terms of treatment adherence
Both treatment protocols consist of 18 sessions 3 sessionweek 45 minutesday of CT with CoRe vs HomeCoRe software training memory and logical-executive functions
Patients with mild dementia early cognitive impairment ie MCI and vascular cognitive impairment VCI and SCI are recruited from NeuropsychologyAlzheimers Disease Assessment Unit and Neurorehabilitation Unit of IRCCS Mondino Foundation Patients diagnosis is formulated on the basis of a comprehensive neuropsychological evaluation baseline cognitive assessment - T0 according to the guidelines presented in the literature The following standardized tests assessing different domains are used
global cognitive function Mini-Mental State Examination MMSE and Montreal Montreal Overall Cognitive Assessment MoCA
memory verbal Verbal Span Digit Span and spatial Corsis blocktapping test - CBTT span verbal long-term memory Logical Memory Test immediate and delayed recall Reys 15-word test immediate and delayed recall spatial long-term memory Rey Complex Figure delayed recall - RCF-dr
logical-executive functions non-verbal reasoning Ravens Matrices 1947 - RM47 frontal functionality Frontal Assessment Battery - FAB semantic fluency animals fruits car brands phonological fluency FAS
attention visual selective attention Attentive Matrices simple speed processing and complex attention Trail Making Test parts A - TMT A and part B - TMT B
visuospatial abilities constructive apraxia Rey Complex Figure copy - RCF-copy
The same battery is also used at follow-up visits parallel versions are applied when available verbal long-term memory tests in order to avoid the learning effect All the test scores are corrected for age sex and education and compared with the values available for the Italian population
At the baseline the cognitive reserve is assessed using Cognitive Reserve Index questionnaire CRIq The patients functional status is assessed using Activities of Daily Living ADL and Instrumental Activities of Daily Living IADL at the baseline and at the last follow-up visit after one year T3 Moreover mood is assessed using the Beck Depression Inventory BDI at the baseline and at the follow-up visits T1 T2 and T3 while quality of life were assessed using the 36-Item Short Form Health Survey questionnaire SF-36 at the baseline and at the follow-up visits six months T2 and one year T3 after training Subjective evaluation of intervention success is also considered by means of the Patient Global Impression of Change PGIC and the Patients Reported Outcome Measures PROMS administered at T0 and T1 Treatment adherence is evaluated considering the number of CT sessions carried out
All the patients recruited undergo baseline cognitive assessment T0 Patients who met the inclusion and exclusion criteria are enrolled and randomly assigned to the experimental group Home CoRe or control group CoRe
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