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

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

Interventions

OTHER

Cognitive and clinical screening

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.

OTHER

Extended neuropsychological assessment

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.

DIAGNOSTIC_TEST

Blood biomarker sampling and APOE genotyping

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.

DIAGNOSTIC_TEST

Non-contrast brain CT scan

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

DIAGNOSTIC_TEST

Multimodal neurophysiological assessment

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.

Sponsors & Collaborators

• University of Florence

  collaborator OTHER

• Fondazione Don Carlo Gnocchi ETS

  lead OTHER

Principal Investigators

• Cristina Polito · IRCCS Fondazione Don Carlo Gnocchi ETS, Firenze

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

45 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-20

Primary Completion

2027-11-30

Completion

2028-12-31

Countries

• Italy

Study Locations