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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,200

participants targeted

Target at P75+ for all trials

Timeline

9mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.1 years study duration

Study Progress83%

Dec 2022Dec 2026

Study Start

First participant enrolled

December 1, 2022

Completed

11 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed

6 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

4.1 years

First QC Date

November 2, 2023

Last Update Submit

April 23, 2025

Conditions

Mild Dementia Mild Cognitive Impairment SCD Alzheimer Disease Lewy Body Disease Frontotemporal Degeneration Vascular Dementia

Outcome Measures

Primary Outcomes (1)

Brain AD pathology as determined by CSF AD biomarkers
CSF Ab42/Ab40 and p-tau217
At baseline (cross-sectional)

Secondary Outcomes (6)

Clinical diagnosis supported by CSF biomarkers
At baseline (cross-sectional)
Brain AD pathology as determined by amyloid amyloid PET imaging
At baseline (cross-sectional)
Brain AD pathology as determined by tau PET imaging
At baseline (cross-sectional)
Progression to AD dementia in patients with SCD or MCI at baseline
At baseline (cross-sectional)
Change in patient management
At baseline (cross-sectional)
+1 more secondary outcomes

Study Arms (1)

Patients in secondary care with cognitive symptoms

Diagnostic Test: Plasma Amyloid Probability Score 2 (APS 2) scoreDiagnostic Test: Plasma ptau217/nptau217Diagnostic Test: Plasma ptau217Diagnostic Test: Plasma neurofilament light (NfL)Diagnostic Test: Plasma Ab42/Ab40

Interventions

Plasma Amyloid Probability Score 2 (APS 2) scoreDIAGNOSTIC_TEST

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.