Rehabilitation of Attention in Patients With MCI and Brain Subcortical Vascular Changes Using the APT-II

NCT02033850 | Completed Results DMC

• 1 other identifier: RF-2010-2321706
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

small vessel disease; cognition; treatment; rehabilitation; attention; fMRI; vascular dementia

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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.

  Baseline, 6 months and 12 months

Secondary Outcomes (6)

• Cognitive Performance (Changes in Scores Approach)

  Baseline, 6 months and 12 months

• Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach)

  Baseline, 6 months and 12 months

• Cognitive Performance Verbal Fluency (Changes in Scores Approach)

  Baseline, 6 months and 12 months

• Cognitive Performance (Clinically Significance Approach)

  Baseline, 6 months and 12 months

• Transition to Dementia

  12 months

Study Arms (2)

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.

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

Interventions

Attention Process Training-II BEHAVIORAL

Rehabilitation of attention using the Attention Process Training-II

APT-II group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \< 18 years

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead
• Ministero della Salute, Italy: collaborator

Study Sites (1)

Stroke Unit and Neurology, VAS-COG clinic

Florence, 50134, Italy

Location

Related Publications (4)

• 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.

  PMID: 27371187 BACKGROUND

• 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(2):615-624. doi: 10.3233/JAD-170428.

  PMID: 28869475 RESULT

• Ciulli 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.

  PMID: 26960231 DERIVED

• Salvadori 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.

  PMID: 26079418 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia, Vascular

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Dementia; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Prof. Leonardo Pantoni, Principal Investigator
• Organization: 'L. Sacco' Department of Biomedical and Clinical Sciences University of Milan

leonardo.pantoni@unimi.it

0039-02-50319865

Study Officials

• Leonardo Pantoni, MD, PhD

  University of Milan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Neurology

Study Record Dates

• First Submitted: December 24, 2013
• First Posted: January 13, 2014
• Study Start: November 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 6, 2019
• Results First Posted: June 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)