Blood biomarkers to predict cognitive/functional decline and mortality in hospitalized older adults
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
This project will test whether specific blood biomarkers can help predict dementia-related decline, rehospitalization, and one-year mortality in older adults hospitalized with neurological or other medical problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Istituto Nazionale di Ricovero e Cura per Anziani Academic / other |
| Locations | 3 sites (Ancona and 2 other locations) |
| Trial ID | NCT07435467 on ClinicalTrials.gov |
What this trial studies
BAD-GER is a multicenter, prospective, three-arm observational project that will collect blood from hospitalized older adults to validate a prognostic algorithm derived from a retrospective discovery cohort of 700 geriatric patients. The study measures plasma levels of Alzheimer's and neuro-injury biomarkers (Aβ42, total and phosphorylated tau, NfL, GFAP), chemokines (CXCL8, CXCL12), and metabolites via metabolomics alongside routine labs and clinical data. Investigators will integrate these biomarkers with immunophenotypes and clinical measures to see if they predict functional/cognitive decline, short-term and one-year mortality, and hospital readmission. Participants are enrolled in three groups—acute neurological inpatients, non-neurological inpatients with dementia, and non-neurological inpatients without dementia—and will have blood collected for analysis and follow-up.
Who should consider this trial
Good fit: Older inpatients at participating hospitals who fall into one of three groups—acute neurological diagnoses (stroke, delirium, status epilepticus, encephalitis/meningitis), non-neurological inpatients with diagnosed major neurocognitive disorder, or non-neurological inpatients without dementia—are ideal candidates.
Not a fit: Younger people, non-hospitalized individuals, and anyone who cannot or does not give informed consent are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the algorithm could help identify hospitalized older adults at high risk of decline or rehospitalization so clinicians can target follow-up and interventions to reduce harm.
How similar studies have performed: Blood biomarkers such as p-tau, NfL, and GFAP have shown promising results for Alzheimer's diagnosis and prognosis, but using them in a combined algorithm to predict rehospitalization and one-year mortality in real-world geriatric inpatients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ancona and 2 other locations
- IRCCS INRCA Hospital — Ancona, Italy (Recruiting)
- IRCCS INRCA Hospital — Fermo, Italy (Recruiting)
- Policlinico Universitario — Messina, Italy (Recruiting)
Study contacts
- Study coordinator: Anna Rita Bonfigli
- Email: a.bonfigli@inrca.it
- Phone: +390718003719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.