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)

NCT07435467 | Recruiting

• 1 other identifier: INRCA_001_2026
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Alzheimer Disease; Old Age; Dementia

Keywords

aging; geriatric; biomarkers; inflammation; neurodegeneration; mortality

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument

  At baseline

• Levels of amyloid ß-42

  At baseline

• Assessment of cognitive function

  At baseline

• Assessment of cognition

  At baseline

• Assessment of frailty

  At baseline

Study Arms (3)

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

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

Patients hospitalized for non-neurological diseases without dementia

Inpatients with non-neurological diseases without dementia

Other: collection of blood samples

Interventions

collection of blood samples OTHER

Serum and EDTA-plasma samples will be collected at baseline

Patients hospitalized for acute neurological disorders; Patients hospitalized for non-neurological diseases with dementia; Patients hospitalized for non-neurological diseases without dementia

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Older inpatients.

You may qualify if:

• Inpatients with one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis

You may not qualify if:

• no informed consent
• GROUP 2: Patients hospitalized for non-neurological diseases with dementia
• 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
• GROUP 3: Patients hospitalized for non-neurological diseases without dementia
• inpatients with non-neurological diseases
• inpatients with one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis
• diagnosis of dementia
• no informed consent

Sponsors & Collaborators

• Istituto Nazionale di Ricovero e Cura per Anziani: lead
• Ministry of Health, Italy: collaborator
• University of Salento: collaborator
• IRCCS Multimedica: collaborator
• Azienda Ospedaliera Universitaria Policlinico "G. Martino": collaborator

Study Sites (3)

IRCCS INRCA Hospital

Ancona, Italy

RECRUITING

IRCCS INRCA Hospital

Fermo, Italy

RECRUITING

Policlinico Universitario

Messina, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and EDTA-plasma samples.

MeSH Terms

Conditions

Alzheimer Disease; Inflammation; Nerve Degeneration

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabiola Olivieri, Professor

  IRCCS INRCA, Ancona, Italy

  STUDY CHAIR

Central Study Contacts

Anna Rita Bonfigli

CONTACT

+390718003719; a.bonfigli@inrca.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 27, 2026
• Study Start: April 9, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

IT (3)