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

Recruiting now · Not applicable

Conditions studied: MCI, Mild Cognitive Impairment (MCI), Mild Cognitive Impairment, Cognitive Deficit, Cognitive Decline

In brief

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.

Key facts

Study ID

NCT07731334

Run by

Fondazione Don Carlo Gnocchi ETS

People needed

384

Starts

2026-01-20

Expected to finish

2028-12-01

Last updated by the study team

2026-08-10

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• IRCCS Fondazione Don Gnocchi ETS — Florence, FI, Italy (enrolling)
• IRCCS Fondazione Don Carlo Gnocchi ETS, Santa Maria Nascente — Milan, Michigan, Italy (enrolling)
• Fondazione Don Carlo Gnocchi ETS, Istituto Palazzolo — Milan, Michigan, Italy (enrolling)

Full record on ClinicalTrials.gov

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