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Recruiting NCT07435467

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)

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Clinical Trial Summary
NCT ID NCT07435467
Status Recruiting
Phase
Sponsor Istituto Nazionale di Ricovero e Cura per Anziani
Condition Alzheimer Disease
Study Type OBSERVATIONAL
Enrollment 400 participants
Start Date 2025-04-09
Primary Completion 2026-06-30

Trial Parameters

Condition Alzheimer Disease
Sponsor Istituto Nazionale di Ricovero e Cura per Anziani
Study Type OBSERVATIONAL
Phase N/A
Enrollment 400
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2025-04-09
Completion 2026-06-30
Interventions
collection of blood samples

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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.

Eligibility 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

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