Rehabilitation of Attention in Patients With MCI and Brain Subcortical Vascular Changes Using the APT-II
NCT02033850, Not applicable, Completed, Azienda Ospedaliero-Universitaria Careggi; results first posted 2019-06-06
Trial 11
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Rehabilitation of Attention in Patients With MCI and Brain Subcortical Vascular Changes Using the APT-II | ClinicalTrials.gov |
| NCT number | NCT02033850 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 46 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Azienda Ospedaliero-Universitaria Careggi | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Attention Process Training-II | ClinicalTrials.gov |
| First posted | 2014-01-13 | ClinicalTrials.gov |
| Last updated | 2019-06-06 | ClinicalTrials.gov |
| Results first posted | 2019-06-06 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Functionality in Activities of Daily Living (Changes in Scores Approach) | 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). | ClinicalTrials.gov |
| Primary | Quality of Life (Changes in Scores Approach) | 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). | ClinicalTrials.gov |
| Primary | Quality of Life (Clinically Significance Approach) | 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. | ClinicalTrials.gov |
| Secondary | Cognitive Performance (Changes in Scores Approach) | Baseline, 6 months and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach) | Baseline, 6 months and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Cognitive Performance Verbal Fluency (Changes in Scores Approach) | Baseline, 6 months and 12 months | 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. | ClinicalTrials.gov |
| Secondary | Cognitive Performance (Clinically Significance Approach) | Baseline, 6 months and 12 months | 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 | ClinicalTrials.gov |
| Secondary | Transition to Dementia | 12 months | 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. | ClinicalTrials.gov |
| Secondary | Cognitive Plasticity | Baseline, 12 months | 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). | ClinicalTrials.gov |
Outcomes 9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Functionality in Activities of Daily Living (Changes in Scores Approach) | Baseline, 6 months and 12 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Quality of Life (Changes in Scores Approach) | Baseline, 6 months and 12 months | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Quality of Life (Clinically Significance Approach) | Baseline, 6 months and 12 months | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov | |
| SECONDARY | Cognitive Performance (Changes in Scores Approach) | Baseline, 6 months and 12 months | Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end | units on a scale | MEAN | ClinicalTrials.gov |
| SECONDARY | Cognitive Performance TMT-A, TMT-B, Stroop (Changes in Scores Approach) | Baseline, 6 months and 12 months | Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end | seconds | MEAN | ClinicalTrials.gov |
| SECONDARY | Cognitive Performance Verbal Fluency (Changes in Scores Approach) | Baseline, 6 months and 12 months | Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end | words | MEAN | ClinicalTrials.gov |
| SECONDARY | Cognitive Performance (Clinically Significance Approach) | Baseline, 6 months and 12 months | Not all the participants completed the entire neuropsychological evaluation during the follow-up visits due to refuse or failure to learn or remember the instructions, or to perform the task until the end | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov |
| SECONDARY | Transition to Dementia | 12 months | Participants | COUNT_OF_PARTICIPANTS | ClinicalTrials.gov | |
| SECONDARY | Cognitive Plasticity | Baseline, 12 months | RsfMRI data were available in in 22 patients (12 treated and 10 non-treated) after the exclusion of patients for technical reasons or head movement greater than 2 mm, and patients with incidental non-lacunar infarcts in the cerebral cortex, cerebellum, or brainstem to avoid a possible confounding effect on rsfMRI analysis. | standard Z-values | MEDIAN | ClinicalTrials.gov |
Results by group 342
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on ADL (baseline vs 6 months) | 0.1 | Standard Deviation 0.3 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on ADL (baseline vs 6 months) | 0 | Standard Deviation 0 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on ADL (6 vs 12 months) | -0.1 | Standard Deviation 0.4 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on ADL (6 vs 12 months) | -0.2 | Standard Deviation 0.7 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on ADL (baseline vs 12 months) | 0 | Standard Deviation 0.9 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on ADL (baseline vs 12 months) | -0.2 | Standard Deviation 0.7 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on IADL (baseline vs 6 months) | -0.4 | Standard Deviation 1.1 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on IADL (baseline vs 6 months) | 0 | Standard Deviation 0.9 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on IADL (6 vs 12 months) | -0.3 | Standard Deviation 1.3 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on IADL (6 vs 12 months) | -1 | Standard Deviation 1.7 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on IADL (baseline vs 12 months) | -0.7 | Standard Deviation 1.1 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on IADL (baseline vs 12 months) | -1 | Standard Deviation 1.7 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on DAD (baseline vs 6 months) | -2.2 | Standard Deviation 10.3 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on DAD (baseline vs 6 months) | -3.9 | Standard Deviation 11.3 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on DAD (6 vs 12 months) | -6.2 | Standard Deviation 20.2 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on DAD (6 vs 12 months) | -3 | Standard Deviation 11.1 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | APT-II Group | Δs on DAD (baseline vs 12 months) | -8.4 | Standard Deviation 21.1 | units on a scale | ClinicalTrials.gov |
| Functionality in Activities of Daily Living (Changes in Scores Approach) | Standard Care Group | Δs on DAD (baseline vs 12 months) | -6.9 | Standard Deviation 17.2 | units on a scale | ClinicalTrials.gov |
| Quality of Life (Changes in Scores Approach) | APT-II Group | Δs on AQ (baseline vs 6 months) | -1.3 | Standard Deviation 7.8 | units on a scale | ClinicalTrials.gov |
| Quality of Life (Changes in Scores Approach) | Standard Care Group | Δs on AQ (baseline vs 6 months) | 2.1 | Standard Deviation 9.3 | units on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | APT-II Group | 23 | ClinicalTrials.gov | |
| Overall Study | STARTED | Standard Care Group | 23 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | APT-II Group | 21 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Standard Care Group | 22 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | APT-II Group | 2 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Standard Care Group | 1 | ClinicalTrials.gov |
Adverse events 4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| serious | Cerebral haemorrhage | Vascular disorders | APT-II Group | 0 | 23 | 0 | ClinicalTrials.gov |
| serious | Cerebral haemorrhage | Vascular disorders | Standard Care Group | 1 | 23 | 1 | ClinicalTrials.gov |
| serious | Gastrointestinal perforation | Gastrointestinal disorders | APT-II Group | 1 | 23 | 1 | ClinicalTrials.gov |
| serious | Gastrointestinal perforation | Gastrointestinal disorders | Standard Care Group | 0 | 23 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | APT-II Group | 1 | 23 | ClinicalTrials.gov |
| Total, all-cause mortality | Standard Care Group | 0 | 23 | ClinicalTrials.gov |
| Total, other adverse events | APT-II Group | 0 | 23 | ClinicalTrials.gov |
| Total, other adverse events | Standard Care Group | 0 | 23 | ClinicalTrials.gov |
| Total, serious adverse events | APT-II Group | 1 | 23 | ClinicalTrials.gov |
| Total, serious adverse events | Standard Care Group | 1 | 23 | ClinicalTrials.gov |
Papers 4
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| APT-II Group vs Standard Care Group: deaths from any cause | Trial comparisons |
| APT-II Group vs Standard Care Group: serious adverse events | Trial comparisons |
Tests 7
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Symbol Coding | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)