N/A
N=46
Rehabilitation of Attention in Patients With MCI and Brain Subcortical Vascular Changes Using the APT-II
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT02033850 ↗Enrolled (actual)
46
Serious AEs
4.4%
Results posted
Jun 2019
Primary outcome: Primary: Functionality in Activities of Daily Living (Changes in Scores Approach) — 0.1; 0; -0.1; -0.2 units on a scale — p=.145
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Attention Process Training-II (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functionality in Activities of Daily Living (Changes in Scores Approach) |
0.1; 0; -0.1; -0.2; 0; -0.2 | .145 |
| PRIMARY Quality of Life (Changes in Scores Approach) |
-1.3; 2.1; -3.8; -3.3; -5.1; -1.2 | .204 |
| PRIMARY Quality of Life (Clinically Significance Approach) |
19; 19; 2; 3; 18; 18 | .095 |
| SECONDARY Cognitive Performance (Changes in Scores Approach) |
1.1; 1.1; 0.8; -0.3; 2; 0.8 | .936 |
| SECONDARY Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach) |
0.4; -1.7; 1.7; -3.4; 2.2; -5.1 | .743 |
| SECONDARY Cognitive Performance Verbal Fluency (Changes in Scores Approach) |
0; 0.3; 0.1; -0.3; 0.1; 0 | .882 |
| SECONDARY Cognitive Performance (Clinically Significance Approach) |
18; 20; 2; 2; 20; 18 | .920 |
| SECONDARY Transition to Dementia |
3; 5; 17; 17; 1; 0 | .478 |
| SECONDARY Cognitive Plasticity |
0.78; -0.66; 1.02; -0.86; 1.31; -1.27 | 0.029 sig |
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. 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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02033850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.