- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04889560
Home-based Cognitive Treatment and Cognitive Impairment
Home-based Cognitive Treatment of Early Stages of Cognitive Impairment in Neurodegenerative Diseases: Home CoRe
Study Overview
Status
Conditions
Intervention / 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Bottiroli, PhD
- Phone Number: 0382 380201
- Email: sara.bottiroli@mondino.it
Study Contact Backup
- Name: Cinzia Fattore, MD
- Phone Number: 0382 380385
- Email: cinzia.fattore@mondino.it
Study Locations
-
-
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Pavia, Italy, 27100
- Recruiting
- Dementia Research Center
-
Contact:
- Sara Bottiroli, PhD
- Phone Number: 0382 380201
- Email: sara.bottiroli@mondino.it
-
Contact:
- Stefano Cappa, MD
- Phone Number: 0382380351
- Email: stefano.cappa@mondino.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- presence of mild dementia, mild cognitive impairment; vascular cognitive impairment, subjective cognitive impairment;
- age between 50 and 85 years;
- educational level ≥ 5 years.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group
Experimental group receives Home CoRe (Home CoRe Group)
|
Home-based version of a computerized cognitive training (CoRe)
|
Other: Control group
Control group receives CoRe software (CoRe Group)
|
Computerized cognitive training (CoRe)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from T0 to T1, T2 and T3
|
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.
|
Change from T0 to T1, T2 and T3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory - BDI
Time Frame: Change from T0 to T1, T2 and T3
|
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.
|
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
|
Quality of life assessed by SF-36.
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
|
Change from T0 to T1, T2 and T3
|
Patient Global Impression of Change - PGIC
Time Frame: Change from T0 to T1
|
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.
|
Change from T0 to T1
|
Patients Reported Outcome Measures (PROMS)
Time Frame: Change from T0 to T1
|
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.
|
Change from T0 to T1
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Number of CT sessions completed
Time Frame: Change from T0 to T1, T2 and T3
|
Treatment adherence assessed by number of cognitive training sessions completed.
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Change from T0 to T1, T2 and T3
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Clinical Dementia Rating Scale (CDR)
Time Frame: Change from T0 to T1, T2 and T3
|
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.
|
Change from T0 to T1, T2 and T3
|
Collaborators and Investigators
Investigators
- Principal Investigator: Stefano Cappa, Prof, IRCCS Mondino Foundation, Pavia
Publications and helpful links
General 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.
- McKhann 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.
- Lampit 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.
- Hsu 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.
- Livingston 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.
- Coyle 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.
- Prehn 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.
- Hachinski 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. Erratum In: Stroke. 2007 Mar;38(3):1118. Wallin, Anders [added].
- Sachdev 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.
- Mendonca 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.
- Bernini 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.
- Bernini 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.
- Bernini 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Home CoRe 2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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