BLAD is a prospective, monocentric, observational epidemiological study with an additional procedure (annual blood draw) evaluating the diagnostic and prognostic performance of plasma biomarkers for Alzheimer's disease (AD) in a large cohort of patients attending the Cognitive Disorders and Dementia Center (CDCD) at IRCCS San Raffaele Hospital, Milan, Italy.
2000 patients will be enrolled and followed annually for 5 years. A validation sub-study (150 patients) will compare plasma biomarkers against CSF biomarkers as the gold standard.
The study aims to establish plasma biomarkers as a less invasive and more cost-effective alternative to CSF analysis and amyloid-PET for the diagnosis and prognosis of AD.
Age greater than or equal to 40 years (patients of childbearing age are admitted).
Subjective or objective cognitive complaints, progressive in nature and of suspected neurodegenerative origin.
Mini-Mental State Examination (MMSE) score greater than or equal to 18.
Availability of CSF biomarkers for Alzheimer's disease within 6 months of the blood draw.
Secondary forms of cognitive impairment based on medical history, neurological examination, and neuroimaging findings.
Pregnancy or breastfeeding.
Rapidly progressive cognitive decline occurring over weeks or months, typically indicative of prion disease, neoplasia, or metabolic disorders.
Subjects who require a legal guardian or tutor.