Blood Tests for Alzheimer's Disease: Can Plasma Biomarkers Diagnose and Predict Disease Progression | NCT07717567

NCT07717567

Overview

NCT ID: NCT07717567
Lead Sponsor: IRCCS San RaffaeleOTHER
Official Title: The Diagnostic and Prognostic Role of Plasma Biomarkers in Alzheimer's Disease
Brief 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.
Conditions: Alzheimer Disease
Mild Cognitive Impairment

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 21, 2026Actual
Start Date: Sep 12, 2023Actual
Primary Completion Date: Jun 1, 2032Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria (main study and sub-study):

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.

Additional inclusion criterion for the validation sub-study:

Availability of CSF biomarkers for Alzheimer's disease within 6 months of the blood draw.

Exclusion Criteria (main study):

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.

Exclusion Criteria (validation sub-study):

Secondary forms of cognitive impairment based on medical history, neurological examination, and neuroimaging findings.

Pregnancy.

Rapidly progressive cognitive decline occurring over weeks or months, typically indicative of prion disease, neoplasia, or metabolic disorders.

Subjects who are unable to give informed consent and require a legal guardian or tutor.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 2,000Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: Federica Agosta, MDContact
agosta.federica@hsr.it0226433051

Similar Studies

Participant Group/Arms

Main Study Cohort

2000 adult patients attending the Cognitive Disorders and Dementia Center (CDCD) at IRCCS San Raffaele Hospital with subjective or objective cognitive complaints of progressive and suspected neurodegenerative nature. All patients undergo annual blood sampling for 5 years in addition to standard clinical follow-up.

Procedure: Annual blood draw for plasma biomarker measurement

Validation Sub-study Cohort

150 patients from the main cohort who undergo lumbar puncture as part of their routine diagnostic workup and have CSF biomarkers for Alzheimer's disease available within 6 months of blood draw. Only those with CSF biomarkers confirming a biological diagnosis of Alzheimer's disease continue longitudinal follow-up in the sub-study.

Procedure: Annual blood draw for plasma biomarker measurement