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RECRUITING
NCT07717567

Blood Tests for Alzheimer's Disease: Can Plasma Biomarkers Diagnose and Predict Disease Progression

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

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