Blood tests using plasma biomarkers to diagnose and track Alzheimer’s disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BLAD is a prospective, monocentric observational study at IRCCS San Raffaele in Milan that collects annual blood samples over 5 years from patients with cognitive concerns. It aims to determine how well plasma biomarkers (including Abeta, pTau-181, NfL, and others) distinguish Alzheimer's disease from other conditions and predict progression. A validation sub-study will compare plasma biomarker results with CSF biomarkers to see how accurate the blood tests are. The study recruits patients seen in routine clinical practice and follows them longitudinally without intervening treatments. The goal is to establish a less invasive, more affordable option for AD diagnosis and prognosis compared with CSF analysis or amyloid-PET.

Why it matters

Who can join: the full rules

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.

Where it's running

• IRCCS Ospedale San Raffaele - Cognitive Disorders and Dementia Center (CDCD)
  Milan, Milano, Italy Recruiting

Study contacts

• Principal investigator: Massimo Filippi, Prof, MD — IRCCS San Raffaele
• Study coordinator: Federica Agosta, MD
• Email: agosta.federica@hsr.it
• Phone: 0226433051

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.