Mild Cognitive Impairment Clinical Trial
— RehAttOfficial title:
The Rehabilitation of Attention in Patients With Mild Cognitive Impairment and Brain Subcortical Vascular Changes Using the Attention Process Training-II
Verified date | February 2019 |
Source | Azienda Ospedaliero-Universitaria Careggi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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. Exclusion Criteria: - Age < 18 years |
Country | Name | City | State |
---|---|---|---|
Italy | Stroke Unit and Neurology, VAS-COG clinic | Firenze |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Careggi | Ministero della Salute, Italy |
Italy,
Pantoni 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 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functionality in Activities of Daily Living (Changes in Scores Approach) | Changes in scores (?) approach. Delta scores (?s) 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 ?s were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. ?s 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). |
Baseline, 6 months and 12 months | |
Primary | Quality of Life (Changes in Scores Approach) | Changes in scores (?) approach. Delta scores (?s) 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 ?s were calculated in order that a positive score indicates an improvement, while a negative score indicates a worsening. ?s 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). |
Baseline, 6 months and 12 months | |
Primary | 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. | Baseline, 6 months and 12 months | |
Secondary | Cognitive Performance (Changes in Scores Approach) | Delta (?) 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 ? score indicates an improvement, while a negative ? 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. |
Baseline, 6 months and 12 months | |
Secondary | Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach) | Delta (?) 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 ? score indicates an improvement, while a negative ? 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. |
Baseline, 6 months and 12 months | |
Secondary | Cognitive Performance Verbal Fluency (Changes in Scores Approach) | Delta (?) 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 ? score indicates an improvement, while a negative ? 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. |
Baseline, 6 months and 12 months | |
Secondary | 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 |
Baseline, 6 months and 12 months | |
Secondary | 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. |
12 months | |
Secondary | 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). | Baseline, 12 months |
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