Cognitive ImpairmentNCT04889560
Home-based Cognitive Treatment and Cognitive Impairment
A study testing Experimental group in people with Cognitive Impairment, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jun 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presence of mild dementia, mild cognitive impairment; vascular cognitive impairment, subjective cognitive impairment;
- age between 50 and 85 years;
- educational level ≥ 5 years.
Who cannot join
- MMSE < 20
- CRD > 1
- pre-existing cognitive impairment (e.g. aphasia, neglect);
- severe disturbances in consciousness;
- concomitant severe psychiatric disease or others neurological conditions (e.g. depression and behavioral disorders).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Dementia Research Center
Pavia, 27100
Stefano Cappa, MD, 0382380351, stefano.cappa@mondino.it
Sara Bottiroli, PhD, 0382 380201, sara.bottiroli@mondino.it
About this study
Official title: Home-based Cognitive Treatment of Early Stages of Cognitive Impairment in Neurodegenerative Diseases: Home CoRe
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.
Read the 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 Alzheimer's 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 therapist's 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 session/week, 45 minutes/day) of CT with CoRe vs HomeCoRe software (training memory and logical-executive functions).
Patients with mild dementia, early cognitive impairment (i.e., MCI and vascular cognitive impairment (VCI)), and SCI are recruited from Neuropsychology/Alzheimer's 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 (Corsi's blocktapping test - CBTT) span; verbal long-term memory (Logical Memory Test immediate and delayed recall; Rey's 15-word test immediate and delayed recall); spatial long-term memory (Rey Complex Figure delayed recall - RCF-dr);
- logical-executive functions: non-verbal reasoning (Raven's 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).
- Conditions
- Cognitive Impairment
- Being tested
- Experimental group, Control group
- Keywords
- Neurodegenerative disease, Cognitive decline, Non-pharmacological treatments, Cognitive training, Home-based CT
- Medical subject headings
- Cognitive Dysfunction, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupOther
Home-based version of a computerized cognitive training (CoRe)
Control groupOther
Computerized cognitive training (CoRe)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group receives Home CoRe (Home CoRe Group) Receives: Other: Experimental group |
| Control group | Other | Control group receives CoRe software (CoRe Group) Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-Mental State Examination (MMSE)
Global cognitive functioning measured by MMSE. MMSE is a neuropsychological test for the evaluation of intellectual efficiency disorders and the presence of cognitive impairment. The total score is between a minimum of 0 and a maximum of 30 points. A score of 18 or less indicates a severe impairment of cognitive abilities a score between 18 and 24 indicates moderate to mild impairment, a score of 25 is considered borderline, and a score of 26 to 30 indicates cognitive normality.
Measured: Change from T0 to T1, T2 and T3
Montreal Overall Cognitive Assessment (MoCA)
Global cognitive functioning measured by MoCA. MoCA is a widely used screening assessment for detecting cognitive impairment. The MoCA test is a 30-point test. Lower score is worst outcome.
Measured: Change from T0 to T1, T2 and T3
Secondary outcomes (6)
Beck Depression Inventory - BDI
Mood assessed by BDI. BDI is a 21-question multiple-choice self-report inventory. Higher total scores indicate more severe depressive symptoms. Each question has a set of at least four possible responses, ranging in intensity. Higher total scores indicate more severe depressive symptoms.
Measured: Change from T0 to T1, T2 and T3
Short Form-36 Health Survey - SF-36
Quality of life assessed by SF-36. The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Measured: Change from T0 to T1, T2 and T3
Patient Global Impression of Change - PGIC
Subjective evaluation of intervention success assessed by PGIC. The self-report measure PGIC reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement.
Measured: Change from T0 to T1
Patients Reported Outcome Measures (PROMS)
Subjective evaluation of intervention success assessed by PROMS. PROMs are used to assess a patient's health status at a particular point in time. PROMs tools can be completed either during an illness or while treating a health condition. In some cases, using pre- and post-event PROMs can help measure the impact of an intervention.
Measured: Change from T0 to T1
Number of CT sessions completed
Treatment adherence assessed by number of cognitive training sessions completed.
Measured: Change from T0 to T1, T2 and T3
Clinical Dementia Rating Scale (CDR)
The evolution of cognitive profile assessed by CDR. The CDR Dementia Staging Instrument in one aspect is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer disease and related dementias: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care.
Measured: Change from T0 to T1, T2 and T3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start30 Jun 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefano Cappa, Prof, Principal investigator, IRCCS Mondino Foundation, Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889560
- Sponsor's protocol ID
- Home CoRe 2021
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
PubMed 21514249Coyle H, Traynor V, Solowij N. Computerized and virtual reality cognitive training for individuals at high risk of cognitive decline: systematic review of the literature. Am J Geriatr Psychiatry. 2015 Apr;23(4):335-359. doi: 10.1016/j.jagp.2014.04.009. Epub 2014 May 14.
PubMed 24998488Hachinski V, Iadecola C, Petersen RC, Breteler MM, Nyenhuis DL, Black SE, Powers WJ, DeCarli C, Merino JG, Kalaria RN, Vinters HV, Holtzman DM, Rosenberg GA, Wallin A, Dichgans M, Marler JR, Leblanc GG. National Institute of Neurological Disorders and Stroke-Canadian Stroke Network vascular cognitive impairment harmonization standards. Stroke. 2006 Sep;37(9):2220-41. doi: 10.1161/01.STR.0000237236.88823.47. Epub 2006 Aug 17.
PubMed 16917086Hsu WY, Ku Y, Zanto TP, Gazzaley A. Effects of noninvasive brain stimulation on cognitive function in healthy aging and Alzheimer's disease: a systematic review and meta-analysis. Neurobiol Aging. 2015 Aug;36(8):2348-59. doi: 10.1016/j.neurobiolaging.2015.04.016. Epub 2015 May 1.
PubMed 26022770Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.
PubMed 25405755Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.
PubMed 28735855Mendonca MD, Alves L, Bugalho P. From Subjective Cognitive Complaints to Dementia: Who is at Risk?: A Systematic Review. Am J Alzheimers Dis Other Demen. 2016 Mar;31(2):105-14. doi: 10.1177/1533317515592331.
PubMed 26142292McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
PubMed 21514250Prehn K, Floel A. Potentials and limits to enhance cognitive functions in healthy and pathological aging by tDCS. Front Cell Neurosci. 2015 Sep 14;9:355. doi: 10.3389/fncel.2015.00355. eCollection 2015.
PubMed 26441526Sachdev PS, Blacker D, Blazer DG, Ganguli M, Jeste DV, Paulsen JS, Petersen RC. Classifying neurocognitive disorders: the DSM-5 approach. Nat Rev Neurol. 2014 Nov;10(11):634-42. doi: 10.1038/nrneurol.2014.181. Epub 2014 Sep 30.
PubMed 25266297Bernini S, Alloni A, Panzarasa S, Picascia M, Quaglini S, Tassorelli C, Sinforiani E. A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease. NeuroRehabilitation. 2019;44(4):555-567. doi: 10.3233/NRE-192714.
PubMed 31256092Bernini S, Panzarasa S, Barbieri M, Sinforiani E, Quaglini S, Tassorelli C, Bottiroli S. A double-blind randomized controlled trial of the efficacy of cognitive training delivered using two different methods in mild cognitive impairment in Parkinson's disease: preliminary report of benefits associated with the use of a computerized tool. Aging Clin Exp Res. 2021 Jun;33(6):1567-1575. doi: 10.1007/s40520-020-01665-2. Epub 2020 Sep 8.
PubMed 32895890Bernini S, Valcarenghi A, Panzarasa S, Quaglini S, Costa A, Ramusino MC, Picascia M, Barbieri M, Tassorelli C, Vecchi T, Bottiroli S. HomeCoRe for telerehabilitation in mild or major neurocognitive disorders: a non-inferiority randomized controlled trial. Geroscience. 2026 Feb;48(1):121-134. doi: 10.1007/s11357-025-02006-9. Epub 2025 Nov 13.
PubMed 41225283Bernini S, Panzarasa S, Sinforiani E, Quaglini S, Cappa SF, Cerami C, Tassorelli C, Vecchi T, Bottiroli S. HomeCoRe for Telerehabilitation in Mild or Major Neurocognitive Disorders: A Study Protocol for a Randomized Controlled Trial. Front Neurol. 2021 Dec 23;12:752830. doi: 10.3389/fneur.2021.752830. eCollection 2021.
PubMed 35002919
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Cognitive Treatment of Early Stages of Cognitive Impairment in Neurodegenerative Diseases: Home CoRe
- ClinicalTrials.gov ID
- NCT04889560
- Acronym / sponsor ID
- Home CoRe 2021
- Conditions
- Cognitive Impairment
- Keywords
- Neurodegenerative disease, Cognitive decline, Non-pharmacological treatments, Cognitive training, Home-based CT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" FoundationUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Alzheimer's 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 therapist's 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 session/week, 45 minutes/day) of CT with CoRe vs HomeCoRe software (training memory and logical-executive functions).
Patients with mild dementia, early cognitive impairment (i.e., MCI and vascular cognitive impairment (VCI)), and SCI are recruited from Neuropsychology/Alzheimer's 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 (Corsi's blocktapping test - CBTT) span; verbal long-term memory (Logical Memory Test immediate and delayed recall; Rey's 15-word test immediate and delayed recall); spatial long-term memory (Rey Complex Figure delayed recall - RCF-dr);
- logical-executive functions: non-verbal reasoning (Raven's 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Experimental groupExperimental group receives Home CoRe (Home CoRe Group) |
| Control group | Other | Other: Control groupControl group receives CoRe software (CoRe Group) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presence of mild dementia, mild cognitive impairment; vascular cognitive impairment, subjective cognitive impairment;
- age between 50 and 85 years;
- educational level ≥ 5 years.
Key exclusion criteria (5 listed)
- MMSE < 20
- CRD > 1
- pre-existing cognitive impairment (e.g. aphasia, neglect);
- severe disturbances in consciousness;
- concomitant severe psychiatric disease or others neurological conditions (e.g. depression and behavioral disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental groupHome-based version of a computerized cognitive training (CoRe) | Other | Experimental group |
| Control groupComputerized cognitive training (CoRe) | Other | Control group |
Primary outcome
Mini-Mental State Examination (MMSE)
Time frame: Change from T0 to T1, T2 and T3
Global cognitive functioning measured by MMSE. MMSE is a neuropsychological test for the evaluation of intellectual efficiency disorders and the presence of cognitive impairment. The total score is between a minimum of 0 and a maximum of 30 points. A score of 18 or less indicates a severe impairment of cognitive abilities a score between 18 and 24 indicates moderate to mild impairment, a score of 25 is considered borderline, and a score of 26 to 30 indicates cognitive normality.
Montreal Overall Cognitive Assessment (MoCA)
Time frame: Change from T0 to T1, T2 and T3
Global cognitive functioning measured by MoCA. MoCA is a widely used screening assessment for detecting cognitive impairment. The MoCA test is a 30-point test. Lower score is worst outcome.
6 secondary outcomes
Beck Depression Inventory - BDI
Time frame: Change from T0 to T1, T2 and T3
Short Form-36 Health Survey - SF-36
Time frame: Change from T0 to T1, T2 and T3
Patient Global Impression of Change - PGIC
Time frame: Change from T0 to T1
Patients Reported Outcome Measures (PROMS)
Time frame: Change from T0 to T1
Number of CT sessions completed
Time frame: Change from T0 to T1, T2 and T3
Clinical Dementia Rating Scale (CDR)
Time frame: Change from T0 to T1, T2 and T3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Background: PubMed 21514249Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
- Background: PubMed 24998488Coyle H, Traynor V, Solowij N. Computerized and virtual reality cognitive training for individuals at high risk of cognitive decline: systematic review of the literature. Am J Geriatr Psychiatry. 2015 Apr;23(4):335-359. doi: 10.1016/j.jagp.2014.04.009. Epub 2014 May 14.
- Background: PubMed 16917086Hachinski V, Iadecola C, Petersen RC, Breteler MM, Nyenhuis DL, Black SE, Powers WJ, DeCarli C, Merino JG, Kalaria RN, Vinters HV, Holtzman DM, Rosenberg GA, Wallin A, Dichgans M, Marler JR, Leblanc GG. National Institute of Neurological Disorders and Stroke-Canadian Stroke Network vascular cognitive impairment harmonization standards. Stroke. 2006 Sep;37(9):2220-41. doi: 10.1161/01.STR.0000237236.88823.47. Epub 2006 Aug 17.
- Background: PubMed 26022770Hsu WY, Ku Y, Zanto TP, Gazzaley A. Effects of noninvasive brain stimulation on cognitive function in healthy aging and Alzheimer's disease: a systematic review and meta-analysis. Neurobiol Aging. 2015 Aug;36(8):2348-59. doi: 10.1016/j.neurobiolaging.2015.04.016. Epub 2015 May 1.
- Background: PubMed 25405755Lampit A, Hallock H, Valenzuela M. Computerized cognitive training in cognitively healthy older adults: a systematic review and meta-analysis of effect modifiers. PLoS Med. 2014 Nov 18;11(11):e1001756. doi: 10.1371/journal.pmed.1001756. eCollection 2014 Nov.
- Background: PubMed 28735855Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.
- Background: PubMed 26142292Mendonca MD, Alves L, Bugalho P. From Subjective Cognitive Complaints to Dementia: Who is at Risk?: A Systematic Review. Am J Alzheimers Dis Other Demen. 2016 Mar;31(2):105-14. doi: 10.1177/1533317515592331.
- Background: PubMed 21514250McKhann GM, Knopman DS, Chertkow H, Hyman BT, Jack CR Jr, Kawas CH, Klunk WE, Koroshetz WJ, Manly JJ, Mayeux R, Mohs RC, Morris JC, Rossor MN, Scheltens P, Carrillo MC, Thies B, Weintraub S, Phelps CH. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):263-9. doi: 10.1016/j.jalz.2011.03.005. Epub 2011 Apr 21.
- Background: PubMed 26441526Prehn K, Floel A. Potentials and limits to enhance cognitive functions in healthy and pathological aging by tDCS. Front Cell Neurosci. 2015 Sep 14;9:355. doi: 10.3389/fncel.2015.00355. eCollection 2015.
- Background: PubMed 25266297Sachdev PS, Blacker D, Blazer DG, Ganguli M, Jeste DV, Paulsen JS, Petersen RC. Classifying neurocognitive disorders: the DSM-5 approach. Nat Rev Neurol. 2014 Nov;10(11):634-42. doi: 10.1038/nrneurol.2014.181. Epub 2014 Sep 30.
- Results publication: PubMed 31256092Bernini S, Alloni A, Panzarasa S, Picascia M, Quaglini S, Tassorelli C, Sinforiani E. A computer-based cognitive training in Mild Cognitive Impairment in Parkinson's Disease. NeuroRehabilitation. 2019;44(4):555-567. doi: 10.3233/NRE-192714.
- Results publication: PubMed 32895890Bernini S, Panzarasa S, Barbieri M, Sinforiani E, Quaglini S, Tassorelli C, Bottiroli S. A double-blind randomized controlled trial of the efficacy of cognitive training delivered using two different methods in mild cognitive impairment in Parkinson's disease: preliminary report of benefits associated with the use of a computerized tool. Aging Clin Exp Res. 2021 Jun;33(6):1567-1575. doi: 10.1007/s40520-020-01665-2. Epub 2020 Sep 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Cappa, Prof principal investigator
IRCCS Mondino Foundation, Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Cognitive Impairment, run by IRCCS National Neurological Institute "C. Mondino" Foundation at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Bottiroli, PhD (0382 380201, sara.bottiroli@mondino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-Mental State Examination (MMSE) (time frame: Change from T0 to T1, T2 and T3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889560, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2022.