Mild Cognitive ImpairmentRehAttNCT02033850
Rehabilitation of Attention in Patients With MCI and Brain Subcortical Vascular Changes Using the APT-II
A study testing Attention Process Training-II in people with Mild Cognitive Impairment, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
Background: Subcortical Vascular Dementia (VaD), consequent to deep brain small vessel disease (SVD), is the most frequent form of VaD. The term vascular mild cognitive impairment (VMCI) defines a transitional state between normal ageing and VaD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Attention Process Training-II
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Apr 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be enrolled according to the following criteria:
- MCI defined according to Winblad et al. criteria;
- Evidence of impairment across attention neuropsychological tests;
- Evidence on MRI of subcortical vascular lesions: moderate to severe age-related white matter changes (WMC) according to a modified version of the Fazekas scale.
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Rehabilitation of Attention in Patients With Mild Cognitive Impairment and Brain Subcortical Vascular Changes Using the Attention Process Training-II
Background: Subcortical Vascular Dementia (VaD), consequent to deep brain small vessel disease (SVD), is the most frequent form of VaD. The term vascular mild cognitive impairment (VMCI) defines a transitional state between normal ageing and VaD. Attentional deficits are a common finding in patients affected by VMCI or subcortical VaD. At present, no drug treatment is available to prevent vascular dementia in patients with VMCI or to improve cognitive performances of this large group of patients. Cognitive rehabilitation is directed to achieve functional changes by reinforcing, strengthening, or reestablishing previously learned patterns of behavior, or establishing new patterns of cognitive activity or compensatory mechanisms.
A hierarchical model of attention has been used to build the Attention Process Training-II (APT-II) programme.
Read more
The APT-II programme effectiveness have been demonstrated in traumatic brain injury and post-stroke rehabilitation, but there is an increasing interest in the study of cognitive rehabilitation in pathological processes that evolve over time, such as chronic cerebrovascular diseases (CVD).
Aims: The purpose of this study is to investigate whether the APT-II programme could be a useful tool in the rehabilitation of attention in individuals affected by VMCI with SVD, and if so, whether the improvement in performance is generalized to functionality in daily activities and quality of life.
Main Expected Results and Impact: Considering that the APT-II contains specific exercises to facilitate generalization to daily life, the skills that are learned by each patient during the rehabilitation programme should be generalized to daily activities.
Furthermore, the improvement of cognitive skills should also improve patient's overall quality of life because these learned skills are applicable to real-life situations. The main expected results are: 1) an impact of APT-II on disability, everyday cognition, quality of life, and performance on attention tests at short and long term after rehabilitation programme ending as compared with standard care; 2) a reduction of the risk of transition to dementia at 1 year follow-up as compared with control group.
Read the detailed description
Study design
The present study is a 3-year prospective, single-blinded, randomized clinical trial. The enrolment will be carried out at the Stroke Unit and the VASCOG clinic of the Careggi University Hospital. Forty patients will be enrolled according to the following criteria: 1) MCI defined according to Winblad et al. criteria (19); 2) Evidence of impairment across attention neuropsychological tests; 3) Evidence on MRI of subcortical vascular lesions:
moderate to severe age-related white matter changes (WMC) according to a modified version of the Fazekas scale (20). Exclusion criteria: age<18 years. All enrolled patients will be evaluated at baseline according to the study protocol, that includes: 1) Clinical assessment; 2) Functional, quality of life and mood assessment; 3) Extensive neuropsychological assessment; 4) MRI protocol. After baseline assessment, participants will be randomly assigned to attention training or standard care. Stratified minimization randomization will be used to ensure the balance for possible prognostic factors (i.e., age, gender, MMSE total score, extension and localization of WMC) across the groups. All APT-II sessions will be administered by a clinical neuropsychologist, or an appositely trained graduate student in medicine. The student clinicians will receive a minimum of 30 hours of training with adult rehabilitation patients, and will be closely supervised by the neuropsychologist. Participants in the APT-II group will receive overall up to 40 hours of individual attention process training. Therapy will be administered in one two-hour session each week over a total of 20 weeks. Participants in the standard care group will not receive cognitive training or rehabilitation interventions, will be instructed to have an usual lifestyle, and will be conventionally provided of medication and clinic consultations. Each patient will be followed-up at 6 and 12 months after baseline assessment. During the follow-up visits clinical assessment, an extensive neuropsychological evaluation, and mood, functional, and quality of life assessments will be performed according to the baseline protocol. The MRI protocol will be repeated at 1-year follow-up.
Work Methodology
Baseline and follow-up clinical, neuropsychological, functional, and MRI data will be collected in a dedicated database. Data will be checked and controlled for consistency in real time during collection. At the end of the enrolment, a first exploratory data analysis will be carried out. Postprocessing of neuroimaging acquired at baseline will be performed by an experienced radiologist. At the end of each follow-up (6 and 12 months after enrollment), analysis of data (uni- and multivariate models and effect size measures) will be carried out. All analyses will be performed using SPSS 18 and will be mainly directed to: 1) evaluate the short and long-term effectiveness of the rehabilitation program, using cognitive performance and functional and quality of life measures as dependents variables (within and between groups analyses); 2) identify potential predictors of effectiveness of the rehabilitation program (multivariate model). The variables included in the model will be: demographic and vascular risk factors, baseline cognitive profile and functional status, and preexisting brain structural changes; 3) evaluate the potential protective effect of the rehabilitation program on the increase of cognitive impairment or transition to dementia at 1 year follow-up; 4) evaluate the long-term effect of rehabilitation on brain activation, using f-MRI data, whole-brain histograms, and voxel-based analyses as dependents variables (within and between groups analyses).
Milestones
- Phase 1 (4 months): 1) Project protocol establishment; 2) Dedicated database for data collection construction; 3) MRI protocol determination; 4) Training on cognitive rehabilitation
- Phase 2 (24 months): 1) Baseline patients cohort enrolment and clinical, neuropsychological, functional, and MRI data collection; 2) Neuropsychological rehabilitation program administration; 3) Follow-up assessments (6 and 12 months after enrolment)
- Phase 3 (8 months): 1) Post-processing of neuroimaging acquired at baseline and at 1-year follow-up; 2) Data completeness and consistency control; 3) Data analysis; 4) Dissemination of results
- Conditions
- Mild Cognitive Impairment
- Being tested
- Attention Process Training-II
- Keywords
- small vessel disease, cognition, treatment, rehabilitation, attention, fMRI, vascular dementia
- Medical subject headings
- Cognitive Dysfunction, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attention Process Training-IIBehavioural
Rehabilitation of attention using the Attention Process Training-II
| Study group | Role | What they receive |
|---|---|---|
| APT-II group | Experimental | Intervention: rehabilitation of attention using the Attention Process Training-II.
Participants in the APT-II group will receive overall up to 40 hours of individual attention process training. Therapy will be administered in one two-hour session each week over a total of 20 weeks. Receives: Behavioral: Attention Process Training-II |
| standard care group | No intervention | Participants in the standard care group will not receive cognitive training or rehabilitation interventions, will be instructed to have an usual lifestyle, and will be conventionally provided of medication and clinic consultations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functionality in Activities of Daily Living (Changes in Scores Approach)
Changes in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable.
Scales:
- Activities of Daily Living (ADL): preserved items summed into a global score (minimum and maximum values 0-6: higher scores mean a better outcome).
- Instrumental Activities of Daily Living (IADL): impaired items summed into a global score (minimum and maximum values 0-8: higher scores mean a worse outcome).
- Disability Assessment in Dementia (DAD): 40 dichotomous items summed into a total score and converted into a percentage (minimum and maximum values 0-100: higher scores mean a worse outcome).
Measured: Baseline, 6 months and 12 months
Quality of Life (Changes in Scores Approach)
Changes in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable.
Scales:
- Short Form Health Survey summary scores: Physical and Mental Component Summary (PCS, MCS) (minimum and maximum values 0-100: lower scores mean worse outcome).
- EuroQol (EQ): summary index (min-max values 0-1) and visual analogue scale (minimum and maximum values 0-100: higher scores mean better outcome).
- Attention Questionnaire (AQ) total score (minimum and maximum values 0-36: higher scores mean worse outcome).
- Geriatric Depression Scale (GDS) total score (minimum and maximum values 0-15: higher scores mean worse outcome).
Measured: Baseline, 6 months and 12 months
Quality of Life (Clinically Significance Approach)
Clinically significance approach. The availability of t scores for the Short Form Health Survey (SF-36) Physical and Mental Component Summary scores (MCS, PCS) allowed us to classify each patient evaluation as 'normal well-being' (t score >40) or 'reduced well-being' (t score ≤40) at each visit (higher scores mean a better outcome). Variations in performance categories over time (baseline vs. 6 month; 6 vs. 12 month; baseline vs. 12 month) were evaluated for each patient and dichotomized as: 'stable or better evaluation' or 'worst evaluation'. Variations in performance categories were analyzed using chi square tests.
Measured: Baseline, 6 months and 12 months
Secondary outcomes (6)
Cognitive Performance (Changes in Scores Approach)
Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable.
Test battery: Montreal Cognitive Assessment MoCA (minimum and maximum values 0-30); Mini Mental Status Examination MMSE (minimum and maximum values 0-30), Rey Auditory-Verbal Learning RAVL immediate (minimum and maximum values 0-75) and recall (minimum and maximum values 0-15), Short story (minimum and maximum values 0-28), Rey-Osterrieth Complex Figure ROCF copy and recall (minimum and maximum values 0-36), Visual search (minimum and maximum values 0-50), Symbol Digit Modalities Test SDMT (minimum and maximum values 0-110). Higher scores mean better outcome for all tests.
Measured: Baseline, 6 months and 12 months
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable.
Cognitive tests based on execution time in seconds: Trail Making Test TMT part A (minimum and maximum values 0-300), TMT part B (minimum and maximum values 0-300), and Stroop Test (minimum and maximum values 0-300). Higher scores mean worse outcome.
Measured: Baseline, 6 months and 12 months
Cognitive Performance Verbal Fluency (Changes in Scores Approach)
Delta (Δ) scores were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. A positive Δ score indicates an improvement, while a negative Δ score indicates a worsening. Delta scores were analyzed using independent sample t tests with treatment as the only independent variable.
Cognitive tests based on the total number of words produced: phonemic (minimum and maximum values not applicable) and semantic verbal fluency (minimum and maximum values not applicable). Higher scores mean better outcome for both tests.
Measured: Baseline, 6 months and 12 months
Cognitive Performance (Clinically Significance Approach)
Clinically significance approach. The availability of national norms for the cognitive variables allowed us to classify each patient's performance as 'normal', 'borderline' or 'abnormal' at each visit. Variations in performance categories over time (baseline vs. 6 month; 6 vs. 12 month; baseline vs. 12 month) were evaluated for each patient and dichotomized as: 'stable or better evaluation' or 'worst evaluation'. Variations in performance categories were analyzed using chi square tests.
Test battery:
- global cognitive functioning: Montreal Cognitive Assessment, MoCA; Mini Mental Status Examination, MMSE
- memory: Rey Auditory-Verbal Learning (RAVL) immediate and recall, Short story, Rey-Osterrieth Complex Figure (ROCF) recall
- attention/executive function: Trail Making Test part A and B (TMT-A and B), Visual search, Symbol Digit Modalities Test (SDMT), Stroop Test
- language: phonemic and semantic verbal fluency
- constructional praxis: ROCF copy
Measured: Baseline, 6 months and 12 months
Transition to Dementia
Data collected during the 1-year follow-up visit were used to evaluate the occurrence of a transition from MCI to dementia according to DSM-V criteria.
Chi square test for a 2x2 contingency table was used to compare patients who became demented at 1-year follow-up visit with those who did not, in the two treatment groups.
Measured: 12 months
Cognitive Plasticity
Improvement in long-term brain activity was measured by means of regional homogeneity (ReHo) of resting state functional MRI (rsfMRI) data. Statistical analysis of rsfMRI data was carried out by feeding Z-transformed ReHo data into voxel-wise inter-subject statistics using permutation-based nonparametric inference within the general linear model framework. P-values were calculated employing permutation-based statistics and corrected for multiple comparisons using the 3D parameter settings with threshold-free cluster enhancement, and a p-value <0.05 was considered statistically significant. Z-transformed ReHo differences (12 months-baseline) were computed separately for treated and non-treated patients, and a voxel-wise between-group comparison was used to evaluate the treatment effect . A positive mean of the Z-transformed ReHo differences represents an increase in activation over time (better outcome), and a negative mean represents a decrease in activation over time (worse outcome).
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startNov 2012
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Responsible party
- Principal investigator, Leonardo Pantoni, University of Milan
- Investigators
- Leonardo Pantoni, MD, PhD, Principal investigator, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033850
- Sponsor's protocol ID
- RF-2010-2321706
- Acronym
- RehAtt
- Status last verified
- Feb 2019
- First submitted
- 24 Dec 2013
- Last updated
- 6 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Salvadori E, Poggesi A, Valenti R, Della Rocca E, Diciotti S, Mascalchi M, Inzitari D, Pantoni L. The rehabilitation of attention in patients with mild cognitive impairment and brain subcortical vascular changes using the Attention Process Training-II. The RehAtt Study: rationale, design and methodology. Neurol Sci. 2016 Oct;37(10):1653-62. doi: 10.1007/s10072-016-2649-z. Epub 2016 Jul 1.
PubMed 27371187Pantoni L, Poggesi A, Diciotti S, Valenti R, Orsolini S, Della Rocca E, Inzitari D, Mascalchi M, Salvadori E. Effect of Attention Training in Mild Cognitive Impairment Patients with Subcortical Vascular Changes: The RehAtt Study. J Alzheimers Dis. 2017;60(2):615-624. doi: 10.3233/JAD-170428.
PubMed 28869475Ciulli S, Citi L, Salvadori E, Valenti R, Poggesi A, Inzitari D, Mascalchi M, Toschi N, Pantoni L, Diciotti S. Prediction of Impaired Performance in Trail Making Test in MCI Patients With Small Vessel Disease Using DTI Data. IEEE J Biomed Health Inform. 2016 Jul;20(4):1026-33. doi: 10.1109/JBHI.2016.2537808. Epub 2016 Mar 3.
PubMed 26960231Salvadori E, Poggesi A, Valenti R, Pracucci G, Pescini F, Pasi M, Nannucci S, Marini S, Del Bene A, Ciolli L, Ginestroni A, Diciotti S, Orlandi G, Di Donato I, De Stefano N, Cosottini M, Chiti A, Federico A, Dotti MT, Bonuccelli U, Inzitari D, Pantoni L; VMCI-Tuscany Study Group. Operationalizing mild cognitive impairment criteria in small vessel disease: the VMCI-Tuscany Study. Alzheimers Dement. 2016 Apr;12(4):407-18. doi: 10.1016/j.jalz.2015.02.010. Epub 2015 Jun 13.
PubMed 26079418
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rehabilitation of Attention in Patients With Mild Cognitive Impairment and Brain Subcortical Vascular Changes Using the Attention Process Training-II
- ClinicalTrials.gov ID
- NCT02033850
- Acronym / sponsor ID
- RehAtt / RF-2010-2321706
- Conditions
- Mild Cognitive Impairment
- Keywords
- small vessel disease, cognition, treatment, rehabilitation, attention, fMRI, vascular dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Collaborators
- Ministero della Salute, Italy
- Study start
- Nov 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Jan 2014 (estimated)
- Results
- Posted 6 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Subcortical Vascular Dementia (VaD), consequent to deep brain small vessel disease (SVD), is the most frequent form of VaD. The term vascular mild cognitive impairment (VMCI) defines a transitional state between normal ageing and VaD. Attentional deficits are a common finding in patients affected by VMCI or subcortical VaD. At present, no drug treatment is available to prevent vascular dementia in patients with VMCI or to improve cognitive performances of this large group of patients. Cognitive rehabilitation is directed to achieve functional changes by reinforcing, strengthening, or reestablishing previously learned patterns of behavior, or establishing new patterns of cognitive activity or compensatory mechanisms.
A hierarchical model of attention has been used to build the Attention Process Training-II (APT-II) programme.
The APT-II programme effectiveness have been demonstrated in traumatic brain injury and post-stroke rehabilitation, but there is an increasing interest in the study of cognitive rehabilitation in pathological processes that evolve over time, such as chronic cerebrovascular diseases (CVD).
Aims: The purpose of this study is to investigate whether the APT-II programme could be a useful tool in the rehabilitation of attention in individuals affected by VMCI with SVD, and if so, whether the improvement in performance is generalized to functionality in daily activities and quality of life.
Main Expected Results and Impact: Considering that the APT-II contains specific exercises to facilitate generalization to daily life, the skills that are learned by each patient during the rehabilitation programme should be generalized to daily activities.
Furthermore, the improvement of cognitive skills should also improve patient's overall quality of life because these learned skills are applicable to real-life situations. The main expected results are: 1) an impact of APT-II on disability, everyday cognition, quality of life, and performance on attention tests at short and long term after rehabilitation programme ending as compared with standard care; 2) a reduction of the risk of transition to dementia at 1 year follow-up as compared with control group.
Detailed description
Study design
The present study is a 3-year prospective, single-blinded, randomized clinical trial. The enrolment will be carried out at the Stroke Unit and the VASCOG clinic of the Careggi University Hospital. Forty patients will be enrolled according to the following criteria: 1) MCI defined according to Winblad et al. criteria (19); 2) Evidence of impairment across attention neuropsychological tests; 3) Evidence on MRI of subcortical vascular lesions:
moderate to severe age-related white matter changes (WMC) according to a modified version of the Fazekas scale (20). Exclusion criteria: age<18 years. All enrolled patients will be evaluated at baseline according to the study protocol, that includes: 1) Clinical assessment; 2) Functional, quality of life and mood assessment; 3) Extensive neuropsychological assessment; 4) MRI protocol. After baseline assessment, participants will be randomly assigned to attention training or standard care. Stratified minimization randomization will be used to ensure the balance for possible prognostic factors (i.e., age, gender, MMSE total score, extension and localization of WMC) across the groups. All APT-II sessions will be administered by a clinical neuropsychologist, or an appositely trained graduate student in medicine. The student clinicians will receive a minimum of 30 hours of training with adult rehabilitation patients, and will be closely supervised by the neuropsychologist. Participants in the APT-II group will receive overall up to 40 hours of individual attention process training. Therapy will be administered in one two-hour session each week over a total of 20 weeks. Participants in the standard care group will not receive cognitive training or rehabilitation interventions, will be instructed to have an usual lifestyle, and will be conventionally provided of medication and clinic consultations. Each patient will be followed-up at 6 and 12 months after baseline assessment. During the follow-up visits clinical assessment, an extensive neuropsychological evaluation, and mood, functional, and quality of life assessments will be performed according to the baseline protocol. The MRI protocol will be repeated at 1-year follow-up.
Work Methodology
Baseline and follow-up clinical, neuropsychological, functional, and MRI data will be collected in a dedicated database. Data will be checked and controlled for consistency in real time during collection. At the end of the enrolment, a first exploratory data analysis will be carried out. Postprocessing of neuroimaging acquired at baseline will be performed by an experienced radiologist. At the end of each follow-up (6 and 12 months after enrollment), analysis of data (uni- and multivariate models and effect size measures) will be carried out. All analyses will be performed using SPSS 18 and will be mainly directed to: 1) evaluate the short and long-term effectiveness of the rehabilitation program, using cognitive performance and functional and quality of life measures as dependents variables (within and between groups analyses); 2) identify potential predictors of effectiveness of the rehabilitation program (multivariate model). The variables included in the model will be: demographic and vascular risk factors, baseline cognitive profile and functional status, and preexisting brain structural changes; 3) evaluate the potential protective effect of the rehabilitation program on the increase of cognitive impairment or transition to dementia at 1 year follow-up; 4) evaluate the long-term effect of rehabilitation on brain activation, using f-MRI data, whole-brain histograms, and voxel-based analyses as dependents variables (within and between groups analyses).
Milestones
- Phase 1 (4 months): 1) Project protocol establishment; 2) Dedicated database for data collection construction; 3) MRI protocol determination; 4) Training on cognitive rehabilitation
- Phase 2 (24 months): 1) Baseline patients cohort enrolment and clinical, neuropsychological, functional, and MRI data collection; 2) Neuropsychological rehabilitation program administration; 3) Follow-up assessments (6 and 12 months after enrolment)
- Phase 3 (8 months): 1) Post-processing of neuroimaging acquired at baseline and at 1-year follow-up; 2) Data completeness and consistency control; 3) Data analysis; 4) Dissemination of results
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APT-II group | Experimental | Behavioral: Attention Process Training-IIIntervention: rehabilitation of attention using the Attention Process Training-II. Participants in the APT-II group will receive overall up to 40 hours of individual attention process training. Therapy will be administered in one two-hour session each week over a total of 20 weeks. |
| standard care group | No intervention | –Participants in the standard care group will not receive cognitive training or rehabilitation interventions, will be instructed to have an usual lifestyle, and will be conventionally provided of medication and clinic consultations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- MCI defined according to Winblad et al. criteria;
- Evidence of impairment across attention neuropsychological tests;
- Evidence on MRI of subcortical vascular lesions: moderate to severe age-related white matter changes (WMC) according to a modified version of the Fazekas scale.
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| Attention Process Training-IIRehabilitation of attention using the Attention Process Training-II | Behavioural | APT-II group |
Primary outcome
Functionality in Activities of Daily Living (Changes in Scores Approach)
Time frame: Baseline, 6 months and 12 months
Changes in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable. Scales: * Activities of Daily Living (ADL): preserved items summed into a global score (minimum and maximum values 0-6: higher scores mean a better outcome). * Instrumental Activities of Daily Living (IADL): impaired items summed into a global score (minimum and maximum values 0-8: higher scores mean a worse outcome). * Disability Assessment in Dementia (DAD): 40 dichotomous items summed into a total score and converted into a percentage (minimum and maximum values 0-100: higher scores mean a worse outcome).
Quality of Life (Changes in Scores Approach)
Time frame: Baseline, 6 months and 12 months
Changes in scores (Δ) approach. Delta scores (Δs) were calculated by computing the difference between the scores obtained in 2 evaluations (baseline vs. 6 months; 6 vs. 12 months; baseline vs. 12 months) for each patient. All Δs were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. Δs were analyzed using independent sample t tests with treatment as the only independent variable. Scales: * Short Form Health Survey summary scores: Physical and Mental Component Summary (PCS, MCS) (minimum and maximum values 0-100: lower scores mean worse outcome). * EuroQol (EQ): summary index (min-max values 0-1) and visual analogue scale (minimum and maximum values 0-100: higher scores mean better outcome). * Attention Questionnaire (AQ) total score (minimum and maximum values 0-36: higher scores mean worse outcome). * Geriatric Depression Scale (GDS) total score (minimum and maximum values 0-15: higher scores mean worse outcome).
Quality of Life (Clinically Significance Approach)
Time frame: Baseline, 6 months and 12 months
Clinically significance approach. The availability of t scores for the Short Form Health Survey (SF-36) Physical and Mental Component Summary scores (MCS, PCS) allowed us to classify each patient evaluation as 'normal well-being' (t score >40) or 'reduced well-being' (t score ≤40) at each visit (higher scores mean a better outcome). Variations in performance categories over time (baseline vs. 6 month; 6 vs. 12 month; baseline vs. 12 month) were evaluated for each patient and dichotomized as: 'stable or better evaluation' or 'worst evaluation'. Variations in performance categories were analyzed using chi square tests.
6 secondary outcomes
Cognitive Performance (Changes in Scores Approach)
Time frame: Baseline, 6 months and 12 months
Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)
Time frame: Baseline, 6 months and 12 months
Cognitive Performance Verbal Fluency (Changes in Scores Approach)
Time frame: Baseline, 6 months and 12 months
Cognitive Performance (Clinically Significance Approach)
Time frame: Baseline, 6 months and 12 months
Transition to Dementia
Time frame: 12 months
Cognitive Plasticity
Time frame: Baseline, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27371187Salvadori E, Poggesi A, Valenti R, Della Rocca E, Diciotti S, Mascalchi M, Inzitari D, Pantoni L. The rehabilitation of attention in patients with mild cognitive impairment and brain subcortical vascular changes using the Attention Process Training-II. The RehAtt Study: rationale, design and methodology. Neurol Sci. 2016 Oct;37(10):1653-62. doi: 10.1007/s10072-016-2649-z. Epub 2016 Jul 1.
- Results publication: PubMed 28869475Pantoni L, Poggesi A, Diciotti S, Valenti R, Orsolini S, Della Rocca E, Inzitari D, Mascalchi M, Salvadori E. Effect of Attention Training in Mild Cognitive Impairment Patients with Subcortical Vascular Changes: The RehAtt Study. J Alzheimers Dis. 2017;60(2):615-624. doi: 10.3233/JAD-170428.
- Derived from this study: PubMed 26960231Ciulli S, Citi L, Salvadori E, Valenti R, Poggesi A, Inzitari D, Mascalchi M, Toschi N, Pantoni L, Diciotti S. Prediction of Impaired Performance in Trail Making Test in MCI Patients With Small Vessel Disease Using DTI Data. IEEE J Biomed Health Inform. 2016 Jul;20(4):1026-33. doi: 10.1109/JBHI.2016.2537808. Epub 2016 Mar 3.
- Derived from this study: PubMed 26079418Salvadori E, Poggesi A, Valenti R, Pracucci G, Pescini F, Pasi M, Nannucci S, Marini S, Del Bene A, Ciolli L, Ginestroni A, Diciotti S, Orlandi G, Di Donato I, De Stefano N, Cosottini M, Chiti A, Federico A, Dotti MT, Bonuccelli U, Inzitari D, Pantoni L; VMCI-Tuscany Study Group. Operationalizing mild cognitive impairment criteria in small vessel disease: the VMCI-Tuscany Study. Alzheimers Dement. 2016 Apr;12(4):407-18. doi: 10.1016/j.jalz.2015.02.010. Epub 2015 Jun 13.
- 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.
Leonardo Pantoni, MD, PhD principal investigator
University of Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attention Process Training-II in people with Mild Cognitive Impairment, run by Azienda Ospedaliero-Universitaria Careggi 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jun 2019. 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?
Yes. Results are posted in the registry (first posted 6 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functionality in Activities of Daily Living (Changes in Scores Approach) (time frame: Baseline, 6 months and 12 months). The study lists 3 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 NCT02033850, which also lists 4 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 6 Jun 2019.