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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: collection of blood samples.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Old Age; Dementia. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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): a Multicenter, Observational, 3-arms, Prospective Study
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.
Detailed description
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.
Interventions
- Other collection of blood samples
Serum and EDTA-plasma samples will be collected at baseline
Primary outcome measures
- All-cause Mortality [Time frame: 12 months from enrollment]
- Number of hospital readmission [Time frame: 12 months from enrollment]
Secondary outcome measures (9)
- Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument [Time frame: At baseline]
- Levels of amyloid ß-42 [Time frame: At baseline]
- Assessment of cognitive function [Time frame: At baseline]
- Assessment of cognition [Time frame: At baseline]
- Assessment of frailty [Time frame: At baseline]
- Levels of tau proteins [Time frame: At baseline]
- Marker of neuro-injury [Time frame: At baseline]
- Neuroinflammation [Time frame: At baseline]
- Marker of astrocyte activation [Time frame: At baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 3 centers
- IRCCS INRCA Hospital — Ancona
- IRCCS INRCA Hospital — Fermo
- Policlinico Universitario — Messina
Identifiers
NCT: NCT07435467 · INRCA_001_2026