Prevalence of Mild Cognitive Impairment and Dementia in Patients Admitted to Non-neurological Rehabilitation Wards
NCT07731334, Not applicable, Recruiting, Fondazione Don Carlo Gnocchi ETS
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Prevalence of Mild Cognitive Impairment and Dementia in Patients Admitted to Non-neurological Rehabilitation Wards | ClinicalTrials.gov |
| NCT number | NCT07731334 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 384 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fondazione Don Carlo Gnocchi ETS | ClinicalTrials.gov |
| Conditions | MCI, Mild Cognitive Impairment (MCI), Mild Cognitive Impairment, Cognitive Deficit, Cognitive Decline | ClinicalTrials.gov |
| Interventions | Cognitive and clinical screening, Extended neuropsychological assessment, Blood biomarker sampling and APOE genotyping, Non-contrast brain CT scan, Multimodal neurophysiological assessment | ClinicalTrials.gov |
| First posted | 2026-07-28 | ClinicalTrials.gov |
| Last updated | 2026-08-10 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Prevalence of cognitive impairment among patients admitted for non-neurological causes to the rehabilitation wards | Baseline (T0), within approximately 10 days of hospital admission | Proportion of enrolled patients with cognitive impairment (Unit of Measure: % of patients). Confirmed via a two-stage process: (1) MoCA screening (corrected score range 0-30, higher = better), where an Equivalent Score (ES) of 0-1 in ≥1 domain triggers referral to (2) an extended battery, applying criteria adapted from Jak and Bondi (Jak et al., 2009; Bondi et al., 2014): ES ≤1 (Capitani \& Laiacona, 1997; below the 20th percentile, \~equivalent to \>1 SD below norms) on ≥2 tests within one domain, or ≥1 test in each of 3 domains (memory, language, attention/executive functioning). ES ranges 0-4 (0=worse, 4=better). Calculated as (patients with confirmed impairment / total enrolled) × 100, with 95% CI. | ClinicalTrials.gov |
| Secondary | Rate of previously undiagnosed cognitive impairment | Baseline (T0), within approximately 10 days of hospital admission | Proportion of patients with confirmed cognitive impairment (Unit of Measure: % of patients with confirmed cognitive impairment; per the neuropsychological criteria defined in the Primary Outcome Measure) who had no prior documented diagnosis of cognitive impairment in their clinical history, calculated as (number of patients with previously undiagnosed cognitive impairment / number of patients with confirmed cognitive impairment) × 100, with 95% CI. | ClinicalTrials.gov |
| Secondary | Clinical and demographic characteristics associated with cognitive status at baseline | Baseline (T0), within approximately 10 days of hospital admission | Comparison of sociodemographic and clinical variables (Unit of Measure: N/A - descriptive comparison across subgroups) among subgroups defined by Montreal Cognitive Assessment (MoCA) Equivalent Score (ES; derived from the 0-30 corrected MoCA total score, higher scores indicating better performance): ES ≥2 (within normative range), ES=1 (borderline), ES=0 (below normative reference limit, worse performance). | ClinicalTrials.gov |
| Secondary | Change in Montreal Cognitive Assessment (MoCA) Total and Domain Scores | Baseline (T0) to 12-month follow-up (T1) | Change between T0 and T1 in MoCA total score (corrected score, range 0-30, higher = better) and MoCA cognitive domain scores, including the Memory Index Score (MIS) and other domain-level indices derived from the Italian MoCA normative reference (Dapor et al., 2025), in patients with confirmed cognitive impairment at baseline: Visuo-spatial (MoCA-V corrected score, range 0-4, higher = better); Attention (MoCA-A corrected score, range 0-6, higher = better); Language (MoCA-L corrected score, range 0-5, higher = better); Executive Functions (MoCA-E corrected score, range 0-4, higher = better); Memory (MoCA-DR corrected score, range 0-5, higher = better); Orientation (MoCA-O corrected score, range 0-6, higher = better); and MIS corrected score, range 0-15, higher = better. | ClinicalTrials.gov |
| Secondary | Change in Digit Span Performance | Baseline (T0) to 12-month follow-up (T1) | Change in forward and backward Digit Span performance (Unit of Measure: number of digits correctly recalled, range 0-9 forward and 0-8 backward; higher = better) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Change in Corsi Block-Tapping Span Performance | Baseline (T0) to 12-month follow-up (T1) | Change in forward and backward Corsi Span performance (Unit of Measure: number of blocks correctly reproduced; range 0-9 forward and 0-8 backward; higher = better) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Change in Rey Auditory Verbal Learning Test (RAVLT) Recall Performance and Memory Efficiency Index | Baseline (T0) to 12-month follow-up (T1) | Change in RAVLT immediate recall (Unit of Measure: number of words recalled, range 0-75; higher = better), delayed recall (number of words recalled, range 0-15; higher = better), recognition (number of words correctly recognized, range 0-15; higher = better) and Memory Efficiency Index (calculated as \[(Delayed Recall/15) / (Total Recall/75)\] + \[(Recognition Hits/15) - (False Positives/Distractors)\]; higher = better) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Change in Rey-Osterrieth Complex Figure (ROCF) Performance | Baseline (T0) to 12-month follow-up (T1) | Change in ROCF copy, immediate and delayed recall accuracy scores (Unit of Measure: accuracy score, range 0-36; higher = better) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Change in Screening for Aphasia in NeuroDegeneration (SAND) Naming Subtest Score | Baseline (T0) to 12-month follow-up (T1) | Change in SAND naming subtest score (Unit of Measure: number of items correctly named, range 0-14; higher = better) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Change in Trail Making Test (TMT) A and B Completion Time | Baseline (T0) to 12-month follow-up (T1) | Change in TMT A and B completion time (Unit of Measure: time to completion in seconds; lower = better; continuous measure, not a bounded scale) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Change in Stroop Colour-Word Test Time and Error Interference Score | Baseline (T0) to 12-month follow-up (T1) | Change in Stroop Colour-Word Test Time and Error Interference scores (Unit of Measure: Time Interference = T3 - \[(T1+T2)/2\], in seconds; Error Interference = E3 - \[(E1+E2)/2\], in number of errors; where T1/E1 and T2/E2 are word-reading and colour-naming performance and T3/E3 is interference-condition performance; lower = better) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Change in Verbal Fluency Performance | Baseline (T0) to 12-month follow-up (T1) | Change in phonemic, semantic, and alternate verbal fluency performance (Unit of Measure: number of correct words generated per condition; higher = better; continuous measure, not a bounded scale) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Change in Cumulative Illness Rating Scale (CIRS) Scores | Baseline (T0) to 12-month follow-up (T1) | Change in CIRS Severity Index (Unit of Measure: mean severity score across organ system categories, range 0-4; higher = worse comorbidity burden) and CIRS Comorbidity Index (Unit of Measure: number of categories with severity score ≥3, i.e., decompensated conditions, range 0-13; higher = worse) between T0 and T1. | ClinicalTrials.gov |
| Secondary | Correlation Between Baseline Cognitive Profile and Plasma GFAP Concentration | Baseline (T0) | Correlation between baseline cognitive performance, assessed using the Montreal Cognitive Assessment (MoCA) and a comprehensive neuropsychological battery, and plasma Glial Fibrillary Acidic Protein concentration (Unit of Measure: pg/mL) in patients with confirmed cognitive impairment. | ClinicalTrials.gov |
| Secondary | Correlation Between Baseline Cognitive Profile and Plasma NfL Concentration | Baseline (T0) | Correlation between baseline cognitive performance, assessed using the Montreal Cognitive Assessment (MoCA) and a comprehensive neuropsychological battery, and plasma neurofilament light chain (NfL) concentration (pg/mL) in patients with confirmed cognitive impairment. | ClinicalTrials.gov |
| Secondary | Correlation Between Baseline Cognitive Profile and Plasma pTau-217 Concentration | Baseline (T0) | Correlation between baseline cognitive performance, assessed using the Montreal Cognitive Assessment (MoCA) and a comprehensive neuropsychological battery, and plasma phosphorylated Tau-217 concentration (Unit of Measure: pg/mL) in patients with confirmed cognitive impairment. | ClinicalTrials.gov |
| Secondary | Correlation Between Baseline Cognitive Profile and APOE ε4 Allele Dose | Baseline (T0) | Correlation between baseline cognitive performance, assessed using the Montreal Cognitive Assessment (MoCA) and a comprehensive neuropsychological battery, and APOE ε4 allele dose (Unit of Measure: number of ε4 alleles per patient: 0, 1, or 2), determined by genotyping, in patients with confirmed cognitive impairment. | ClinicalTrials.gov |
| Secondary | APOE Allelic Frequency Distribution | Baseline (T0) | Distribution of APOE allele frequencies (Unit of Measure: % allelic frequency of ε2, ε3, and ε4, calculated as the proportion of each allele among the total alleles observed) in patients with confirmed cognitive impairment, determined by genotyping. | ClinicalTrials.gov |
| Secondary | Correlation Between Baseline Cognitive Profile and Resting-State EEG Relative Spectral Power | Baseline (T0) | Correlation between baseline cognitive performance, assessed using the Montreal Cognitive Assessment (MoCA) and a comprehensive neuropsychological battery, and resting-state EEG relative spectral power in the delta, theta, alpha, and beta bands (Unit of Measure: % relative spectral power per band) in patients with confirmed cognitive impairment. | ClinicalTrials.gov |
| Secondary | Correlation Between Baseline Cognitive Profile and Auditory P300 Latency | Baseline (T0) | Correlation between baseline cognitive performance, assessed using the Montreal Cognitive Assessment (MoCA) and a comprehensive neuropsychological battery, and P300 latency (Unit of Measure: milliseconds; lower latency = faster processing), elicited via an auditory oddball paradigm, in patients with confirmed cognitive impairment. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 8
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 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 8
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 |
| Corsi Block-Tapping Test | Secondary outcome | ConductCognition |
| Digit Span Test | Secondary outcome | ConductCognition |
| Oddball Target Detection | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | 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)