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Alzheimer DiseaseBAD-GERNCT07435467

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)

An observational study of Alzheimer Disease and Old Age; Dementia, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Alzheimer Disease, Old Age; Dementia
What is being tested?
collection of blood samples
How many people
400 participants
Where
3 sitesItaly
Study dates
9 Apr 2025to 30 Jun 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: Older inpatients.

Who may be able to join

  • Inpatients with one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis
  • inpatients with diagnosis of major neurocognitive disorder according to DSM-5 criteria (2013)
  • inpatients with non-neurological diseases

Who cannot join

  • no informed consent
  • GROUP 2: Patients hospitalized for non-neurological diseases with dementia
  • 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 one of the following diagnoses: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis
  • diagnosis of dementia
  • no informed consent

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anna Rita Bonfigli contact

+390718003719

a.bonfigli@inrca.it

Italy3 sites, 3 recruiting

  • IRCCS INRCA Hospital

    Ancona

    Antonio Cherubini, MD

    Riccardo Sarzani, MD

    Recruiting

  • IRCCS INRCA Hospital

    Fermo

    Cinzia Giuli, PhD

    Roberto Brunelli, MD

    Recruiting

  • Policlinico Universitario

    Messina

    Paolino La Spina, MD

    Paolino La Spina, MD

    Recruiting

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
collection of blood samples
Keywords
aging, geriatric, biomarkers, inflammation, neurodegeneration, mortality
Medical subject headings
Alzheimer Disease, Inflammation, Nerve Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • collection of blood samplesOther

    Serum and EDTA-plasma samples will be collected at baseline

Study groups in NCT07435467
Study groupRoleWhat they receive
Patients hospitalized for acute neurological disordersInpatients with one of the following diagnosis: ischemic or hemorrhagic stroke, delirium, status epilepticus, encephalitis/meningitis
Receives: Other: collection of blood samples
Patients hospitalized for non-neurological diseases with dementiaInpatients with diagnosis of major neurocognitive disorder according to DSM-5 criteria (2013)
Receives: Other: collection of blood samples
Patients hospitalized for non-neurological diseases without dementiaInpatients with non-neurological diseases without dementia
Receives: Other: collection of blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months from enrollment

  2. 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.

    Measured: 12 months from enrollment

Secondary outcomes (9)

  1. 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

    Measured: At baseline

  2. Levels of amyloid ß-42

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

    Measured: At baseline

  3. 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.

    Measured: At baseline

  4. 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).

    Measured: At baseline

  5. 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.

    Measured: At baseline

  6. Levels of tau proteins

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

    Measured: At baseline

  7. Marker of neuro-injury

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

    Measured: At baseline

  8. Neuroinflammation

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

    Measured: At baseline

  9. Marker of astrocyte activation

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

    Measured: At baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start9 Apr 2025
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07435467
Sponsor's protocol ID
INRCA_001_2026
Acronym
BAD-GER
Status last verified
Feb 2026
First submitted
19 Feb 2026
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Alzheimer Disease and Old Age; Dementia, run by Istituto Nazionale di Ricovero e Cura per Anziani at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anna Rita Bonfigli (+390718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: 12 months from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07435467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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