Prevalence of Mild Cognitive Impairment and Dementia in Patients Admitted to Non-neurological Rehabilitation Wards

NCT07731334 | Recruiting

• 1 other identifier: COGinREHAB
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

MCI; Mild Cognitive Impairment (MCI); Mild Cognitive Impairment; Cognitive Deficit; Cognitive Decline

Keywords

Mild Cognitive Impairment; Cognitive Screening; Multimodal Assessment; Cognitive Trajectories; Dementia; Non-Neurological Rehabilitation; Plasma Biomarkers; Neurodegeneration; Neurophysiological Measures; Longitudinal Study; APOE Genotype; MoCA

Outcome Measures

Primary Outcomes (1)

• Prevalence of cognitive impairment among patients admitted for non-neurological causes to the rehabilitation wards

  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.

  Baseline (T0), within approximately 10 days of hospital admission

Secondary Outcomes (27)

• 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)

Study Arms (1)

All enrolled patients

EXPERIMENTAL

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).

Other: Cognitive and clinical screening; Other: Extended neuropsychological assessment; Diagnostic Test: Blood biomarker sampling and APOE genotyping; Diagnostic Test: Non-contrast brain CT scan; Diagnostic Test: Multimodal neurophysiological assessment

Interventions

Cognitive and clinical screening OTHER

Structured collection of clinical/sociodemographic variables (Cumulative Illness Rating Scale -CIRS-, Halm's Clinical Instability Scale -SIC-) and 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), performed at baseline (T0) in all participants.

All enrolled patients

Extended neuropsychological assessment OTHER

Digit Span/Corsi Span (forward/backward), Rey Auditory Verbal Learning Test, Rey-Osterrieth Complex Figure, SAND naming subtest, Trail Making Test A/B, Stroop Colour-Word Test, and phonemic/semantic/alternate verbal fluency, administered at T0 in participants with screening results suggestive of cognitive impairment, and repeated at the 12-month follow-up (T1) in those with confirmed impairment.

All enrolled patients

Blood biomarker sampling and APOE genotyping DIAGNOSTIC_TEST

Venous blood draw for APOE genotyping, including APOE ε4 allele dose (0, 1, or 2 copies) and allelic frequency distribution (ε2, ε3, ε4) (T0 only), and quantification of plasma GFAP, NfL, and pTau-217 (all expressed in pg/mL; T0 and T1), performed in participants with cognitive impairment confirmed by the extended neuropsychological assessment.

All enrolled patients

Non-contrast brain CT scan DIAGNOSTIC_TEST

Single non-contrast brain CT scan performed at T0 in participants with confirmed cognitive impairment.

All enrolled patients

Multimodal neurophysiological assessment DIAGNOSTIC_TEST

Resting-state EEG, quantified as relative spectral power in the delta, theta, alpha, and beta bands (T0 and, in participants with confirmed cognitive impairment, repeated at T1); auditory oddball P300 event-related potentials, quantified as latency and amplitude; actigraphy-based sleep-wake monitoring, quantified as Sleep Efficiency; and overnight polysomnography, quantified as percentage of total sleep time in each sleep stage (N1, N2, N3, and REM); performed at T0 in a subset of participants with confirmed cognitive impairment.

All enrolled patients

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi ETS: lead
• University of Florence: collaborator

Study Sites (3)

IRCCS Fondazione Don Gnocchi ETS

Florence, FI, 50143, Italy

RECRUITING

IRCCS Fondazione Don Carlo Gnocchi ETS, Santa Maria Nascente

Milan, Michigan, 20148, Italy

RECRUITING

Fondazione Don Carlo Gnocchi ETS, Istituto Palazzolo

Milan, Michigan, 20149, Italy

RECRUITING

Related Publications (8)

• Dapor C, Devita M, Iannizzi P, Arbia E, Bruzzano A, Dessi M, Lupi D, Rolandino GM, Rossi M, Saccomano A, Siccardi E, Simonetto A, Vuerich G, Zuliani S, Priftis K. The Montreal cognitive assessment (MoCA) 8.1 version, including the memory index score (MoCA-MIS): Italian norms. Neurol Sci. 2025 Jun;46(6):2581-2589. doi: 10.1007/s10072-025-08066-1. Epub 2025 Mar 17.

  PMID: 40095163 BACKGROUND

• Capitani E, Laiacona M. Composite neuropsychological batteries and demographic correction: standardization based on equivalent scores, with a review of published data. The Italian Group for the Neuropsychological Study of Ageing. J Clin Exp Neuropsychol. 1997 Dec;19(6):795-809. doi: 10.1080/01688639708403761.

  PMID: 9524875 BACKGROUND

• Bondi MW, Edmonds EC, Jak AJ, Clark LR, Delano-Wood L, McDonald CR, Nation DA, Libon DJ, Au R, Galasko D, Salmon DP. Neuropsychological criteria for mild cognitive impairment improves diagnostic precision, biomarker associations, and progression rates. J Alzheimers Dis. 2014;42(1):275-89. doi: 10.3233/JAD-140276.

  PMID: 24844687 BACKGROUND

• Jak AJ, Bondi MW, Delano-Wood L, Wierenga C, Corey-Bloom J, Salmon DP, Delis DC. Quantification of five neuropsychological approaches to defining mild cognitive impairment. Am J Geriatr Psychiatry. 2009 May;17(5):368-75. doi: 10.1097/JGP.0b013e31819431d5.

  PMID: 19390294 BACKGROUND

• Rice R, Bryant J, Fisher RS. Documentation of cognitive impairment screening amongst older hospitalised Australians: a prospective clinical record audit. BMC Geriatr. 2023 Oct 18;23(1):672. doi: 10.1186/s12877-023-04394-z.

  PMID: 37853320 BACKGROUND

• Reynish EL, Hapca SM, De Souza N, Cvoro V, Donnan PT, Guthrie B. Epidemiology and outcomes of people with dementia, delirium, and unspecified cognitive impairment in the general hospital: prospective cohort study of 10,014 admissions. BMC Med. 2017 Jul 27;15(1):140. doi: 10.1186/s12916-017-0899-0.

  PMID: 28747225 BACKGROUND

• Bickel H, Hendlmeier I, Hessler JB, Junge MN, Leonhardt-Achilles S, Weber J, Schaufele M. The Prevalence of Dementia and Cognitive Impairment in Hospitals. Dtsch Arztebl Int. 2018 Nov 2;115(44):733-740. doi: 10.3238/arztebl.2018.0733.

  PMID: 30565543 BACKGROUND

• Mudge AM, Lee-Steere K, Treleaven E, Cahill M, Finnigan S, McRae P. Cognitive impairment in older hospital inpatients: prevalence, care needs and carer perceptions. Aust Health Rev. 2022 Apr;46(2):244-250. doi: 10.1071/AH20286.

  PMID: 34856117 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction; Cognition Disorders; Dementia; Nerve Degeneration

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cristina Polito

  IRCCS Fondazione Don Carlo Gnocchi ETS, Firenze

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Polito

CONTACT

+390557393653; crpolito@dongnocchi.it

Clinical Trial Unit

CONTACT

+390557393653; ctu@DONGNOCCHI.IT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 28, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

IT (3)