Prevalence of Mild Cognitive Impairment and Dementia in Patients Admitted to Non-neurological Rehabilitation Wards
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 384
- 试验地点
- 3
- 主要终点
- Prevalence of cognitive impairment among patients admitted for non-neurological causes to the rehabilitation wards
研究概览
简要总结
Cognitive impairment is common among older adults hospitalized for non-neurological conditions but often goes unrecognized, particularly in rehabilitation settings where clinical attention is mainly focused on physical recovery. The COGinREHAB study is a multicenter, prospective, longitudinal interventional study conducted at three rehabilitation centers of the Fondazione Don Carlo Gnocchi in Italy (Florence and Milan).
The study will enroll 384 patients aged 45 years or older who are hospitalized for at least 7-10 days in cardiac, pulmonary, or orthopedic intensive rehabilitation units, or in intermediate care units, for conditions unrelated to the nervous system.
At admission, all participants undergo a clinical and cognitive screening visit. Patients whose screening results suggest possible cognitive impairment then undergo a more extensive neuropsychological evaluation. In those with confirmed cognitive impairment, additional blood tests are performed to measure biomarkers of neurodegeneration (GFAP, neurofilament light chain, and phosphorylated tau-217), together with APOE genotyping and a non-contrast brain CT scan. In a subset of these patients, resting-state EEG, auditory event-related potentials, actigraphy, and overnight polysomnography are also performed. Patients with confirmed cognitive impairment are invited to a follow-up visit 12 months later to assess whether their cognitive profiles and biological markers have changed.
The main purpose of the study is to estimate how frequently cognitive impairment occurs among patients admitted to non-neurological rehabilitation units, including how often it was previously undiagnosed. The study will also describe the clinical, biological, and neurophysiological profile of these patients and examine how cognitive impairment evolves over one year.
详细描述
Rationale. Cognitive impairment is highly prevalent among hospitalized older adults, with reported rates ranging from approximately 20% to 40% depending on setting and assessment method, yet it remains substantially underdiagnosed in general medical and rehabilitation settings, where clinical priorities are directed toward physical recovery. Undetected cognitive dysfunction has been associated with longer hospital stays, higher rates of medical complications, reduced functional recovery, and increased likelihood of institutionalization. Several conditions commonly managed in non-neurological rehabilitation units - cardiovascular disease, chronic respiratory disease, and depression - are independently associated with an increased risk of cognitive decline, further supporting the need for systematic cognitive screening in these populations.
Objectives. The primary objective is to determine the prevalence of cognitive impairment among patients aged ≥45 years admitted for non-neurological conditions to cardiac, pulmonary, or orthopedic intensive rehabilitation units, or to intermediate care units, of the Fondazione Don Carlo Gnocchi. Secondary objectives: 1) to determine the rate of cognitive impairment not previously documented in the clinical history of patients admitted to the rehabilitation wards of the Don Carlo Gnocchi Foundation for non-neurological conditions; 2) to characterize the clinical and demographic profile of patients in whom MCI or cognitive dysfunction is identified during hospitalization; 3) to evaluate modifications of the clinical profile and the progression of cognitive dysfunction at the 12-month follow-up in patients with confirmed cognitive impairment at baseline; 4) to investigate the correlation between plasma biomarkers of neurodegeneration, APOE ε4 allele dose, and cognitive profile at baseline (T0) in patients with confirmed cognitive impairment; 5) to assess longitudinal changes in plasma biomarkers of neurodegeneration and their correlation with the progression of cognitive impairment in patients presenting cognitive dysfunction at baseline (T0); 6) to evaluate longitudinal changes in resting-state EEG indices, and their correlation with the progression of cognitive impairment, in patients with cognitive dysfunction at baseline (T0); 7) to examine the correlation between baseline neurophysiological measures, including auditory P300 parameters and sleep-wake measures derived from actigraphy and polysomnography, cognitive profile at T0 and cognitive impairment progression at follow-up (T1).
Design and setting. COGinREHAB is a multicenter, prospective, longitudinal interventional study (single-group, diagnostic purpose) conducted over 36 months (January 2026-December 2028) across three sites of the Fondazione Don Carlo Gnocchi in Italy: IRCCS Fondazione Don Gnocchi (Florence); Fondazione Don Gnocchi, Istituto Palazzolo (Milan); IRCCS Fondazione Don Carlo Gnocchi ONLUS, Santa Maria Nascente (Milan).
Procedures. The study protocol comprises two assessment time points (T0 baseline and T1 12-month follow-up), structured as sequential, contingent visits.
T0 - Screening Visit (within 10 days of admission, approximately 60 minutes): review of medical records for prior documentation on cognitive status; collection of sociodemographic and clinical data (age, sex, education, diabetes, current pharmacological treatment, Cumulative Illness Rating Scale [CIRS], Halm's Clinical Instability Scale [SIC]); administration of the Montreal Cognitive Assessment (MoCA), Hospital Anxiety and Depression Scale (HADS), Lifestyle for Brain Health index (LIBRA), Cognitive Reserve Index Questionnaire-Short Version (S-CRIq), Motor Reserve Index Questionnaire (MRIq), and Current Physical Activity Questionnaire (cPAq). Patients with a MoCA Equivalent Score of 0 or 1 (overall or in at least one cognitive domain, including the Memory Index Score) proceed to the Baseline Neuropsychological Assessment. Patients scoring more than 2 standard deviations below normative values (corrected MoCA total score <15.485) are excluded from further baseline assessment, as this is considered indicative of severe cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥45 years
- •Hospitalization for at least 7-10 days for a non-neurological condition, in cardiac, pulmonary, or orthopedic intensive rehabilitation units, or intermediate care units
- •Adequate fluency in the Italian language
- •Provision of written informed consent
排除标准
- •Illiteracy
- •Severe, uncorrected visual impairment and/or hearing loss
- •Severe verbal communication deficit
- •Inability to remain seated for the duration of the assessment
- •Inability to use the dominant upper limb
- •Altered state of consciousness or alertness (e.g., delirium)
- •Severe scalp skin lesions or dermatitis precluding electrode application for neurophysiological recordings
- •Previous or current history of severe psychiatric disorders (e.g., psychotic disorders, bipolar disorder, severe major depressive disorder with psychotic symptoms, current suicidal risk, or other psychiatric conditions judged by the investigator to interfere with study participation, procedural compliance, or interpretation of results)
- •Previous history or current presence of clinically relevant neurological pathologies other than cognitive impairment (e.g., epilepsy, stroke, neurodegenerative diseases such as Parkinson's disease or multiple sclerosis, moderate-to-severe traumatic brain injury, brain tumors, central nervous system infections, or other neurological conditions that may influence cognitive, behavioral, or neurological functioning, or otherwise compromise the study objectives)
研究组 & 干预措施
All enrolled patients
Hospitalized patients aged ≥45 years admitted to cardiac, pulmonary, or orthopedic intensive rehabilitation units, or intermediate care units, for non-neurological conditions. All participants undergo a baseline clinical and cognitive screening visit (T0). Participants whose screening results suggest cognitive impairment undergo an extended neuropsychological assessment; those in whom cognitive impairment is confirmed additionally undergo blood sampling for APOE genotyping and plasma biomarkers of neurodegeneration (GFAP, NfL, pTau-217), a non-contrast brain CT scan, and, in a subset, multimodal neurophysiological assessment (resting-state EEG, auditory P300, actigraphy, polysomnography). Participants with confirmed cognitive impairment at T0 are re-assessed at a 12-month follow-up visit (T1).
干预措施: Non-contrast brain CT scan (Diagnostic Test)
All enrolled patients
Hospitalized patients aged ≥45 years admitted to cardiac, pulmonary, or orthopedic intensive rehabilitation units, or intermediate care units, for non-neurological conditions. All participants undergo a baseline clinical and cognitive screening visit (T0). Participants whose screening results suggest cognitive impairment undergo an extended neuropsychological assessment; those in whom cognitive impairment is confirmed additionally undergo blood sampling for APOE genotyping and plasma biomarkers of neurodegeneration (GFAP, NfL, pTau-217), a non-contrast brain CT scan, and, in a subset, multimodal neurophysiological assessment (resting-state EEG, auditory P300, actigraphy, polysomnography). Participants with confirmed cognitive impairment at T0 are re-assessed at a 12-month follow-up visit (T1).
干预措施: Cognitive and clinical screening (Other)
All enrolled patients
Hospitalized patients aged ≥45 years admitted to cardiac, pulmonary, or orthopedic intensive rehabilitation units, or intermediate care units, for non-neurological conditions. All participants undergo a baseline clinical and cognitive screening visit (T0). Participants whose screening results suggest cognitive impairment undergo an extended neuropsychological assessment; those in whom cognitive impairment is confirmed additionally undergo blood sampling for APOE genotyping and plasma biomarkers of neurodegeneration (GFAP, NfL, pTau-217), a non-contrast brain CT scan, and, in a subset, multimodal neurophysiological assessment (resting-state EEG, auditory P300, actigraphy, polysomnography). Participants with confirmed cognitive impairment at T0 are re-assessed at a 12-month follow-up visit (T1).
干预措施: Extended neuropsychological assessment (Other)
All enrolled patients
Hospitalized patients aged ≥45 years admitted to cardiac, pulmonary, or orthopedic intensive rehabilitation units, or intermediate care units, for non-neurological conditions. All participants undergo a baseline clinical and cognitive screening visit (T0). Participants whose screening results suggest cognitive impairment undergo an extended neuropsychological assessment; those in whom cognitive impairment is confirmed additionally undergo blood sampling for APOE genotyping and plasma biomarkers of neurodegeneration (GFAP, NfL, pTau-217), a non-contrast brain CT scan, and, in a subset, multimodal neurophysiological assessment (resting-state EEG, auditory P300, actigraphy, polysomnography). Participants with confirmed cognitive impairment at T0 are re-assessed at a 12-month follow-up visit (T1).
干预措施: Blood biomarker sampling and APOE genotyping (Diagnostic Test)
All enrolled patients
Hospitalized patients aged ≥45 years admitted to cardiac, pulmonary, or orthopedic intensive rehabilitation units, or intermediate care units, for non-neurological conditions. All participants undergo a baseline clinical and cognitive screening visit (T0). Participants whose screening results suggest cognitive impairment undergo an extended neuropsychological assessment; those in whom cognitive impairment is confirmed additionally undergo blood sampling for APOE genotyping and plasma biomarkers of neurodegeneration (GFAP, NfL, pTau-217), a non-contrast brain CT scan, and, in a subset, multimodal neurophysiological assessment (resting-state EEG, auditory P300, actigraphy, polysomnography). Participants with confirmed cognitive impairment at T0 are re-assessed at a 12-month follow-up visit (T1).
干预措施: Multimodal neurophysiological assessment (Diagnostic Test)
结局指标
主要结局
Prevalence of cognitive impairment among patients admitted for non-neurological causes to the rehabilitation wards
时间窗: 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.
次要结局
- Rate of previously undiagnosed cognitive impairment(Baseline (T0), within approximately 10 days of hospital admission)
- Clinical and demographic characteristics associated with cognitive status at baseline(Baseline (T0), within approximately 10 days of hospital admission)
- Change in Montreal Cognitive Assessment (MoCA) Total and Domain Scores(Baseline (T0) to 12-month follow-up (T1))
- Change in Digit Span Performance(Baseline (T0) to 12-month follow-up (T1))
- Change in Corsi Block-Tapping Span Performance(Baseline (T0) to 12-month follow-up (T1))
- Change in Rey Auditory Verbal Learning Test (RAVLT) Recall Performance and Memory Efficiency Index(Baseline (T0) to 12-month follow-up (T1))
- Change in Rey-Osterrieth Complex Figure (ROCF) Performance(Baseline (T0) to 12-month follow-up (T1))
- Change in Screening for Aphasia in NeuroDegeneration (SAND) Naming Subtest Score(Baseline (T0) to 12-month follow-up (T1))
- Change in Trail Making Test (TMT) A and B Completion Time(Baseline (T0) to 12-month follow-up (T1))
- Change in Stroop Colour-Word Test Time and Error Interference Score(Baseline (T0) to 12-month follow-up (T1))
- Change in Verbal Fluency Performance(Baseline (T0) to 12-month follow-up (T1))
- Change in Cumulative Illness Rating Scale (CIRS) Scores(Baseline (T0) to 12-month follow-up (T1))
- Correlation Between Baseline Cognitive Profile and Plasma GFAP Concentration(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and Plasma NfL Concentration(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and Plasma pTau-217 Concentration(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and APOE ε4 Allele Dose(Baseline (T0))
- APOE Allelic Frequency Distribution(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and Resting-State EEG Relative Spectral Power(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and Auditory P300 Latency(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and Auditory P300 Amplitude(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and Actigraphy-Derived Sleep Efficiency(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and Polysomnography-Derived NREM Sleep Stage Percentages (N1, N2, N3)(Baseline (T0))
- Correlation Between Baseline Cognitive Profile and Polysomnography-Derived REM Sleep Percentage(Baseline (T0))
- Change in Plasma GFAP Concentration and Correlation With Cognitive Performance Over 12 Months(Baseline (T0) to 12-month follow-up (T1))
- Change in Plasma NfL Concentration and Correlation With Cognitive Performance Over 12 Months(Baseline (T0) to 12-month follow-up (T1))
- Change in Plasma pTau217 Concentration and Correlation With Cognitive Performance Over 12 Months(Baseline (T0) to 12-month follow-up (T1))
- Change in Resting-State EEG Relative Spectral Power and Correlation With Cognitive Performance Over 12 Months(Baseline (T0) to 12-month follow-up (T1))