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)

Istituto Nazionale di Ricovero e Cura per Anziani400 enrolled

Overview

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.

Blood levels of amyloid ß-42 (Aß42), total and phosphorylated tau protein (t- and p-tau) associated with other biomarkers of neuro-injury, i.e. neurofilament light (NfL) chain and with biomarkers of neuroinflammation, such as CXCL8, CXCL12 and glial fibrillary acidic protein (GFAP), and metabolites analyzable with metabolomic approach, can provide information not only on neuro-injury, but also on risk of re-hospitalization and mortality. The investigators called these biomarkers BAD-GER biomarkers. The BAD-GER study is a multicenter, prospective, three-arm observational study designed to validate a prognostic biomarker algorithm for mortality and hospital readmission. This algorithm will be derived from a retrospective analysis of Alzheimer's Disease and neurodegeneration biomarkers within an existing discovery cohort of 700 geriatric patients. By integrating clinical data, routine laboratory parameters, immunophenotypes, and specific BAD-GER biomarkers into a minimal dataset, the study will assess associations with functional/cognitive status, as well as short-term and one-year mortality and rehospitalization rates.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Alzheimer Disease Old Age; Dementia

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

GROUP 1: Patients hospitalized for acute neurological disorders Inclusion criteria: * Inpatients with one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis Exclusion criteria: * no informed consent GROUP 2: Patients hospitalized for non-neurological diseases with dementia Inclusion criteria: * inpatients with diagnosis of major neurocognitive disorder according to DSM-5 criteria (2013) Exclusion criteria: * Inpatients with one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis * no informed consent GROUP 3: Patients hospitalized for non-neurological diseases without dementia Inclusion criteria: * inpatients with non-neurological diseases Exclusion criteria: * inpatients with one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis * diagnosis of dementia * no informed consent

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.

Time frame: 12 months from enrollment

Number of hospital readmission

Time frame: 12 months from enrollment

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

Time frame: At baseline

Levels of amyloid ß-42

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

Time frame: At baseline

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

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

Assessment of frailty

It will be assessed by the Clinical Frailty Scale (CFS). This descriptive scale divides the older participants into 9 classes based on the information provided by them and their relatives: between 1 and 3 the patient is non-frail, pre-frail if 4, he is frail from 5 to 9.

Time frame: At baseline

Levels of tau proteins

Plasma levels of total tau (t-tau) and phosphorylated tau (p-tau) will be quantified.

Time frame: At baseline

Marker of neuro-injury

Neurofilament light chain (NfL) levels will be assessed in plasma

Time frame: At baseline

Neuroinflammation

The plasma pro-inflammatory chemokine CXCL8 (Interleukin-8) and the homeostatic chemokine CXCL12 (SDF-1) will be measured

Time frame: At baseline

Marker of astrocyte activation

Plasma concentrations of glial fibrillary acidic protein (GFAP) will be quantified

Time frame: At baseline

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)

Overview

Conditions

Interventions

Eligibility

Locations (3)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts