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

NCT07717567 · tracked via the Priya Life Science Italy tracker

Sponsor

IRCCS San Raffaele

Phase

Observational

Started

2023-09-12

Last updated

2026-07-21

Condition(s) studied

Alzheimer DiseaseMild Cognitive ImpairmentSubjective Cognitive DeclineDementiaCognitive Impairment

Investigational drug(s) / intervention(s)

Annual blood draw for plasma biomarker measurement

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.

Study 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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria (main study and sub-study): 1. Age greater than or equal to 40 years (patients of childbearing age are admitted). 2. Subjective or objective cognitive complaints, progressive in nature and of suspected neurodegenerative origin. 3. Mini-Mental State Examination (MMSE) score greater than or equal to 18. Additional inclusion criterion for the validation sub-study: 4. Availability of CSF biomarkers for Alzheimer's disease within 6 months of the blood draw. Exclusion Criteria (main study): 1. Secondary forms of cognitive impairment based on medical history, neurological examination, and neuroimaging findings. 2. Pregnancy or breastfeeding. 3. Rapidly progressive cognitive decline occurring over weeks or months, typically indicative of prion disease, neoplasia, or metabolic disorders. 4. Subjects who require a legal guardian or tutor. Exclusion Criteria (validation sub-study): 1. Secondary forms of cognitive impairment based on medical history, neurological examination, and neuroimaging findings. 2. Pregnancy. 3. Rapidly progressive cognitive decline occurring over weeks or months, typically indicative of prion disease, neoplasia, or metabolic disorders. 4. Subjects who are unable to give informed consent and require a legal guardian or tutor.

Primary outcome measure(s)

Time to progression to all-cause dementia in MCI patients (primary prognostic endpoint) — Annually from baseline up to 5 years
Time to clinical progression to all-cause dementia in patients with Mild Cognitive Impairment (MCI) at baseline, assessed using multivariable Cox proportional hazards models. For each plasma biomarker, patients are divided into two groups (above/below the median) and compared using the log-rank test (cause-specific hazard). The study has greater than 95% power to detect a Hazard Ratio of 2 and approximately 75-80% power for HR of 1.5.

Trial sites (1)

Facility	City	Region	Status
IRCCS Ospedale San Raffaele - Cognitive Disorders and Dementia Center (CDCD)	Milan	Milano	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07717567 on ClinicalTrials.gov ↗ ← All trials in Italy