NCT06122415 The Swedish BioFINDER - Memory Clinic Study
| NCT ID | NCT06122415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Skane University Hospital |
| Condition | Mild Dementia |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,200 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2026-12-31 |
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 1,200 participants in total. It began in 2022-12-01 with a primary completion date of 2026-12-31.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Under investigation for cognitive symptoms at the Memory clinic. 2. 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. Exclusion Criteria: 1. Not undergoing CSF or blood sampling as part of clinical practice. 2. Not undergoing cognitive testing as part of clinical practice.
Contact & Investigator
Erik Stomrud, MD, PhD
PRINCIPAL INVESTIGATOR
Skane University Hospital and Lund University
Frequently Asked Questions
Who can join the NCT06122415 clinical trial?
This trial is open to participants of all sexes, studying Mild Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06122415 currently recruiting?
Yes, NCT06122415 is actively recruiting participants. Contact the research team at erik.stomrud@med.lu.se for enrollment information.
Where is the NCT06122415 trial being conducted?
This trial is being conducted at Malmö, Sweden.
Who is sponsoring the NCT06122415 clinical trial?
NCT06122415 is sponsored by Skane University Hospital. The principal investigator is Erik Stomrud, MD, PhD at Skane University Hospital and Lund University. The trial plans to enroll 1,200 participants.