The diagnosis of diseases causing memory difficulties or dementia is often challenging. Without the use of advanced methods such as cerebrospinal fluid tests, approximately 25-30% do not receive a correct diagnosis today. However, the investigators have recently developed new blood biomarkers with high diagnostic accuracy, and the investigators now want to investigate whether they can eventually replace cerebrospinal fluid tests. This is because blood tests are much more cost-effective and significantly easier for patients compared to cerebrospinal fluid tests.
In this study, 1200 patients undergoing clinical evaluations at the Memory Clinic, Skåne University Hospital in Malmö, are included for blood and cerebrospinal fluid sample collection. The blood samples are sent for analysis using the new blood biomarkers. Subsequently, the results are compared with those from the clinical analysis of cerebrospinal fluid to determine how well they perform in routine clinical practice as an alternative to cerebrospinal fluid tests and whether the blood test improves patient care. This comparison is carried out by the attending physician in three steps:
1. Assessment without access to the results of either the blood test or cerebrospinal fluid test. 2. Assessment with access to only the results of the blood test. 3. Assessment with access to the results of both the blood test and cerebrospinal fluid test.
Aim 1) To prospectively validate plasma Alzheimer's disease (AD) biomarkers for diagnosis of patients with cognitive symptoms who are evaluated in a specialist memory clinic.
Aim 2) Determine whether blood AD biomarkers improve patient management in specialist memory clinic settings.
Under investigation for cognitive symptoms at the Memory clinic.
Cerebrospinal fluid and blood sampling is planned to be done as part of clinical practice even if the patient is not taking part of this study.
Not undergoing CSF or blood sampling as part of clinical practice.
Not undergoing cognitive testing as part of clinical practice.
Patients with cognitive symptoms (SCD, MCI or dementia) at a secondary memory clinic.
Cohort
Prospective
Plasma Amyloid Probability Score 2 (APS 2) score
Diagnostic testAPS 2 score (combination of ptau217/nptau217 and Ab42/Ab40). The cut off will be predefined. The samples will be analysed prospectively every two weeks.
Plasma ptau217/nptau217
Diagnostic testThe cut off will be predefined. The samples will be analysed prospectively every two weeks.
Plasma ptau217
Diagnostic testThe cut off will be predefined. The samples will be analysed prospectively every two weeks.
Plasma neurofilament light (NfL)
Diagnostic testThe cut off will be predefined. The samples will be analysed prospectively every two weeks.
Plasma Ab42/Ab40
Diagnostic testThe cut off will be predefined. The samples will be analysed prospectively every two weeks.
Brain AD pathology as determined by CSF AD biomarkers
CSF Ab42/Ab40 and p-tau217
Clinical diagnosis supported by CSF biomarkers
Clinical diagnosis based on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) but supported by CSF biomarkers
Brain AD pathology as determined by amyloid amyloid PET imaging
Amyloid PET imaging
Brain AD pathology as determined by tau PET imaging
Tau PET imaging
Progression to AD dementia in patients with SCD or MCI at baseline
Development of AD dementia during follow-up diagnosed using DSM-5 and supported by CSF biomarkers
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Skane University Hospital
Lead sponsor
Lund University
Collaborator
