About this trial
The BAD-GER study is a multicenter, prospective, three-arm observational study serving to validate a prognostic biomarker algorithm for mortality and hospital readmission; this algorithm will be developed through the retrospective analysis of Alzheimer's Disease and neurodegeneration biomarkers in an already available discovery cohort of 700 previously hospitalized geriatric patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inpatients with one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis
Disqualifiers
no informed consent
inpatients with diagnosis of major neurocognitive disorder according to DSM-5 criteria (2013)
Inpatients with one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis
no informed consent
Trial population
Older inpatients.
Trial design
Case-control
Prospective
Treatments tested in this trial
collection of blood samples
Other interventionSerum and EDTA-plasma samples will be collected at baseline
Treatment groups
Trial outcomes
Primary outcomes
All-cause Mortality
To validate the prognostic value of a biomarker algorithm derived from a retrospective analysis of Alzheimer's disease and neurodegeneration biomarkers within an existing discovery cohort of 700 geriatric inpatients.
Number of hospital readmission
To validate the prognostic value of a biomarker algorithm derived from a retrospective analysis of Alzheimer's disease and neurodegeneration biomarkers within an existing discovery cohort of 700 geriatric inpatients.
Secondary outcomes
Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument
Identification information, personal data at admission, assessment date, cognitive function, communication and vision, mood and behaviour, physical function, incontinence, diagnosis of the disease, health conditions, oral and nutrition status, skin conditions, medications, treatment and procedures, advanced directives, discharge potential, discharge, assessment information, anamnestic-clinical data, standardised clinical assessment, physical performance tests
Levels of amyloid ß-42
The levels of plasma amyloid ß-42 (Aß42) are assessed.
Assessment of cognitive function
Cognitive function will be assessed using the Mini Mental State Examination (MMSE). Score ranges 0-30, with higher score indicating better cognitive function.
Assessment of cognition
Clinical Dementia Rating Scale (CDR) is a cognitive test that is used to assess the severity of dementia. It evaluates six cognitive and functional domains, where the scores are summed to provide a total score from 0 (no cognitive impairment) to 30 (severe impairment).
Sponsors and contacts
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Istituto Nazionale di Ricovero e Cura per Anziani
Lead sponsor
Ministry of Health, Italy
Collaborator
University of Salento
Collaborator
IRCCS Multimedica
Collaborator
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Collaborator