Actively Recruiting

All Genders
NCT06122415

The Swedish BioFINDER - Memory Clinic Study

Led by Skane University Hospital · Updated on 2026-04-06

1200

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

Sponsors

S

Skane University Hospital

Lead Sponsor

L

Lund University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

The Swedish BioFINDER - Memory Clinic Study

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 Eligible

You will not qualify if you...

  • Not undergoing CSF or blood sampling as part of clinical practice.
  • Not undergoing cognitive testing as part of clinical practice.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Skåne University Hospital

Malmö, Sweden

Actively Recruiting

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Research Team

E

Erik Stomrud, MD, PhD

CONTACT

S

Sebastian Palmqvist, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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The Swedish BioFINDER - Memory Clinic Study | DecenTrialz