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NCT Number: NCT07435467

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)

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Inflammation Mental Disorders Nerve Degeneration Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Old Age; Dementia Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS INRCA Hospital, Ancona, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of blood samples

Other

Serum and EDTA-plasma samples will be collected at baseline

Primary outcomes

  1. All-cause Mortality

    Time frame: 12 months from enrollment

    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.

  2. Number of hospital readmission

    Time frame: 12 months from enrollment

    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.

Secondary outcomes

  1. Comprehensive geriatric assessment by INTERRAI-MDS-AC/VAOR-AC instrument

    Time frame: At baseline

    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

  2. Levels of amyloid ß-42

    Time frame: At baseline

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

  3. Assessment of cognitive function

    Time frame: At baseline

    Cognitive function will be assessed using the Mini Mental State Examination (MMSE). Score ranges 0-30, with higher score indicating better cognitive function.

  4. Assessment of cognition

    Time frame: At baseline

    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).

  5. Assessment of frailty

    Time frame: At baseline

    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.

  6. Levels of tau proteins

    Time frame: At baseline

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

  7. Marker of neuro-injury

    Time frame: At baseline

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

  8. Neuroinflammation

    Time frame: At baseline

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

  9. Marker of astrocyte activation

    Time frame: At baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Rita Bonfigli

CONTACT

[email protected]

+390718003719

Sponsors and collaborators

Lead sponsor

Istituto Nazionale di Ricovero e Cura per Anziani

Other

Collaborators

  • Azienda Ospedaliera Universitaria Policlinico "G. Martino"
  • IRCCS Multimedica
  • Ministry of Health, Italy
  • University of Salento

Registry information

Official study 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

Acronym: BAD-GER

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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