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The Swedish BioFINDER - Memory Clinic Study

Study acronym: Validate
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Study Status, Oversight, Contacts/Locations, Referencesv5
  2. Minor 2 versions Re-verified since Nov 30, 2024, no change to tracked fieldsv3-v4
  3. Minor Interventions: Plasma APS 2 score (Diagnostic Test), Plasma Ab42/Ab40 (Diagnostic Test), Plasma NfL (Diagnostic Test), Plasma ptau217 (Diagnostic Test)… to Plasma Ab42/Ab40 (Diagnostic Test), Plasma Amyloid Probability Score 2 (APS 2) score (Diagnostic Test), Plasma neurofilament light (NfL)…
    • Secondary endpoints: details revised at 1 of 6 entries
    • Study description expanded, about 14 words
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06122415
Lead Sponsor Skane University Hospital
Collaborators: Lund University
Conditions
(from sponsor)
Mild Dementia, Mild Cognitive Impairment, SCD, Alzheimer Disease, Lewy Body Disease, Frontotemporal Degeneration, Vascular Dementia
Related terms Alzheimer Disease, Cognitive Dysfunction, Dementia, Vascular, Lewy Body Disease
Enrollment 1,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov