Clinical Research Directory
Browse clinical research sites, groups, and studies.
Blood Tests for Alzheimer's Disease: Can Plasma Biomarkers Diagnose and Predict Disease Progression
Sponsor: IRCCS San Raffaele
Summary
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.
Official title: The Diagnostic and Prognostic Role of Plasma Biomarkers in Alzheimer's Disease
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
OBSERVATIONAL
Enrollment
2000
Start Date
2023-09-12
Completion Date
2032-06-01
Last Updated
2026-07-21
Healthy Volunteers
No
Conditions
Interventions
Annual blood draw for plasma biomarker measurement
A blood sample is collected once per year for 5 years (additional procedure beyond standard clinical care) for measurement of plasma biomarkers including: Abeta40, Abeta42, Abeta42/Abeta40 ratio, pTau-181, NfL, ApoE, ApoE4, GFAP, sTREM2, and other plasma neurodegeneration biomarkers. Blood draw is a routine clinical procedure with no specific contraindications. The only possible side effect is local hematoma at the puncture site. Plasma biomarker measurement is performed using a CE-marked medical device (Fujirebio, provided on free loan). Results do not modify the patient's standard diagnostic and therapeutic pathway.
Locations (1)
IRCCS Ospedale San Raffaele - Cognitive Disorders and Dementia Center (CDCD)
Milan, Milano, Italy