RecruitingNCT06122415

The Swedish BioFINDER - Memory Clinic Study


Sponsor

Skane University Hospital

Enrollment

1,200 participants

Start Date

Dec 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

Plain Language Summary

Simplified for easier understanding

This study, called the Swedish BioFINDER Memory Clinic Study, is collecting blood and spinal fluid samples from people who are already being evaluated at a Memory Clinic for memory concerns, in order to identify better biomarkers (biological signals) for diagnosing and monitoring Alzheimer's disease and related dementias. **You may be eligible if...** - You are already being evaluated at a Memory Clinic for cognitive symptoms - Your clinical care plan already includes spinal fluid and blood sampling as part of your normal medical workup **You may NOT be eligible if...** - You are not having spinal fluid or blood tests as part of your clinical care - You are not receiving cognitive testing as part of your clinical care Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPlasma Amyloid Probability Score 2 (APS 2) score

APS 2 score (combination of ptau217/nptau217 and Ab42/Ab40). The cut off will be predefined. The samples will be analysed prospectively every two weeks.

DIAGNOSTIC_TESTPlasma ptau217/nptau217

The cut off will be predefined. The samples will be analysed prospectively every two weeks.

DIAGNOSTIC_TESTPlasma ptau217

The cut off will be predefined. The samples will be analysed prospectively every two weeks.

DIAGNOSTIC_TESTPlasma neurofilament light (NfL)

The cut off will be predefined. The samples will be analysed prospectively every two weeks.

DIAGNOSTIC_TESTPlasma Ab42/Ab40

The cut off will be predefined. The samples will be analysed prospectively every two weeks.


Locations(1)

Skåne University Hospital

Malmö, Sweden

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NCT06122415


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