NCT07717567 Blood Tests for Alzheimer's Disease: Can Plasma Biomarkers Diagnose and Predict Disease Progression
| NCT ID | NCT07717567 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2032-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2023-09-12 with a primary completion date of 2032-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Massimo Filippi, Prof, MD
PRINCIPAL INVESTIGATOR
IRCCS San Raffaele
Frequently Asked Questions
Who can join the NCT07717567 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07717567 currently recruiting?
Yes, NCT07717567 is actively recruiting participants. Contact the research team at agosta.federica@hsr.it for enrollment information.
Where is the NCT07717567 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT07717567 clinical trial?
NCT07717567 is sponsored by IRCCS San Raffaele. The principal investigator is Massimo Filippi, Prof, MD at IRCCS San Raffaele. The trial plans to enroll 2,000 participants.
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