Blood Tests for Alzheimer's Disease: Can Plasma Biomarkers Diagnose and Predict Disease Progression
Recruiting · NCT07717567 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS San Raffaele
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- IRCCS Ospedale San Raffaele - Cognitive Disorders and Dementia Center (CDCD) - Milan, Milano, Italy