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) (BAD-GER)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Old Age; Dementia
• Intervention / Treatment: Other: collection of blood samples

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Anna Rita Bonfigli; Phone Number: +390718003719; Email: a.bonfigli@inrca.it

Study Locations

• Italy
  • Ancona, Italy
    • Recruiting
    • IRCCS INRCA Hospital
    • Principal Investigator: Antonio Cherubini, MD
    • Principal Investigator: Riccardo Sarzani, MD
    • Principal Investigator: Leonardo Biscetti, MD
  • Fermo, Italy
    • Recruiting
    • IRCCS INRCA Hospital
    • Contact: Cinzia Giuli, PhD
    • Principal Investigator: Roberto Brunelli, MD
  • Messina, Italy
    • Recruiting
    • Policlinico Universitario
    • Contact: Paolino La Spina, MD
    • Principal Investigator: Paolino La Spina, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Older inpatients.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients hospitalized for acute neurological disorders; Inpatients with one of the following diagnosis: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis	Other: collection of blood samples; Serum and EDTA-plasma samples will be collected at baseline
Patients hospitalized for non-neurological diseases with dementia; Inpatients with diagnosis of major neurocognitive disorder according to DSM-5 criteria (2013)	Other: collection of blood samples; Serum and EDTA-plasma samples will be collected at baseline
Patients hospitalized for non-neurological diseases without dementia; Inpatients with non-neurological diseases without dementia	Other: collection of blood samples; Serum and EDTA-plasma samples will be collected at baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months from enrollment
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.	12 months from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At baseline
Levels of amyloid ß-42	The levels of plasma amyloid ß-42 (Aß42) are assessed.	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.	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).	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.	At baseline
Levels of tau proteins	Plasma levels of total tau (t-tau) and phosphorylated tau (p-tau) will be quantified.	At baseline
Marker of neuro-injury	Neurofilament light chain (NfL) levels will be assessed in plasma	At baseline
Neuroinflammation	The plasma pro-inflammatory chemokine CXCL8 (Interleukin-8) and the homeostatic chemokine CXCL12 (SDF-1) will be measured	At baseline
Marker of astrocyte activation	Plasma concentrations of glial fibrillary acidic protein (GFAP) will be quantified	At baseline

Collaborators and Investigators

• Sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
• Collaborators: Ministry of Health, Italy; Azienda Ospedaliera Universitaria Policlinico "G. Martino"; IRCCS Multimedica; University of Salento
• Investigators: Study Chair: Fabiola Olivieri, Professor, IRCCS INRCA, Ancona, Italy

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: biomarkers; aging; neurodegeneration; inflammation; mortality; geriatric
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Pathological Conditions, Signs and Symptoms; Alzheimer Disease; Inflammation; Nerve Degeneration
• Other Study ID Numbers: INRCA_001_2026

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No