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

RecruitingN/A

Sponsor: IRCCS San Raffaele

Conditions: Alzheimer Disease, Mild Cognitive Impairment, Subjective Cognitive Decline, Dementia, Cognitive Impairment

Interventions: Annual blood draw for plasma biomarker measurement

Countries: Italy

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 overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Milan, Milano, Italy