Blood Biomarkers for Alzheimer Disease and Neuro-injury to Estimate the Association With Cognitive/Functional Decline and Mortality in a Real-world Population of GERiatric Hospitalized Patients (BAD-GER)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age65+
SponsorIstituto Nazionale di Ricovero e Cura per Anziani

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • collection of blood samples

    Other intervention

    Serum and EDTA-plasma samples will be collected at baseline

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Patients hospitalized for acute neurological disorders1 intervention
Group B: Patients hospitalized for non-neurological diseases with dementia1 intervention
Group C: Patients hospitalized for non-neurological diseases without dementia1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months from enrollment
2

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.

Time frame
12 months from enrollment

Secondary outcomes

1

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

Time frame
At baseline
2

Levels of amyloid ß-42

The levels of plasma amyloid ß-42 (Aß42) are assessed.

Time frame
At baseline
3

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.

Time frame
At baseline
4

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).

Time frame
At baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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