Actively Recruiting
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
Led by Istituto Nazionale di Ricovero e Cura per Anziani · Updated on 2026-02-27
400
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Nazionale di Ricovero e Cura per Anziani
Lead Sponsor
M
Ministry of Health, Italy
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating blood biomarkers related to Alzheimer's Disease and neuro-injury to understand their association with cognitive and functional decline, mortality, and hospital readmission in older hospitalized patients. This multicenter, prospective observational study aims to validate a prognostic algorithm developed from a prior retrospective analysis of biomarkers in a cohort of 700 geriatric patients. The study integrates clinical, laboratory, and biomarker data to assess these relationships in a real-world population. The study involves three groups of hospitalized patients: those with acute neurological disorders such as stroke or delirium, those with major neurocognitive disorder (dementia), and those hospitalized for non-neurological diseases without dementia. Blood samples will be collected at baseline to measure amyloid ß-42, tau proteins, neuro-injury markers, neuroinflammation markers, and astrocyte activation. The research will observe participants over 12 months to record mortality and hospital readmission rates. Participants will undergo comprehensive geriatric assessments and evaluations of cognitive function and frailty at the start of the study. Blood biomarker levels will be analyzed alongside clinical data to explore their association with outcomes. The primary outcomes include all-cause mortality and number of hospital readmissions within 12 months of enrollment. This observational study does not involve treatment interventions but focuses on monitoring and data collection to improve understanding of disease progression and risks in elderly hospitalized patients.
CONDITIONS
Brief 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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 65 years or older
- Inpatients diagnosed with ischemic or hemorrhagic stroke, delirium, status epilepticus, or encephalitis/meningitis (Group 1)
- Inpatients diagnosed with major neurocognitive disorder according to DSM-5 criteria (Group 2)
- Inpatients with non-neurological diseases without dementia (Group 3)
- Ability to provide informed consent
You will not qualify if you...
- Lack of informed consent
- For Group 2: patients with ischemic or hemorrhagic stroke, delirium, status epilepticus, or encephalitis/meningitis
- For Group 3: patients with ischemic or hemorrhagic stroke, delirium, status epilepticus, or encephalitis/meningitis
- For Group 3: diagnosis of dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants provide blood samples and undergo assessments to measure biomarkers and cognitive, functional, and frailty status.
1 visit (in-person)
Duration - 12 months from enrollment
Participants are monitored for mortality and hospital readmission over 12 months.
Follow-up contacts as part of routine care
Trial Site Locations
Total: 3 locations
1
IRCCS INRCA Hospital
Ancona, Italy
Actively Recruiting
2
IRCCS INRCA Hospital
Fermo, Italy
Actively Recruiting
3
Policlinico Universitario
Messina, Italy
Actively Recruiting
Research Team
A
Anna Rita Bonfigli
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here