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The Diagnostic and Prognostic Role of Plasma Biomarkers in Alzheimer's Disease

Status: Recruiting

Location: See location...

Intervention Type: Procedure

Study Type: Observational

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

Participation Requirements

Sex: All

Minimum Age: 40

Healthy Volunteers: f

View:

• 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.

Locations

Other Locations

Italy

IRCCS Ospedale San Raffaele - Cognitive Disorders and Dementia Center (CDCD)

RECRUITING

Milan

Contact Information

Primary

Federica Agosta, MD

agosta.federica@hsr.it

0226433051

Backup

Giuseppe Magnani, MD

Time Frame

Start Date: 2023-09-12

Estimated Completion Date: 2032-06-01

Participants

Target number of participants: 2000

Treatments

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.

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.

Related Therapeutic Areas

Alzheimer's Disease

Dementia

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