The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease

Summary

Cognitive disorders have a broad differential diagnosis, and a precise, timely diagnosis is essential for personalized treatment and care. Currently, dementia diagnoses are often not further specified according to the underlying pathology and are frequently delayed by several years. However, with the upcoming disease-modifying treatments (DMTs) for AD, an accurate, pathology-driven (i.e., etiological) diagnosis will become necessary. Blood-based biomarkers (BBMs) are promising tools for detecting Alzheimer's disease (AD), with current research showing high concordance with cerebrospinal fluid (CSF) biomarkers and amyloid PET imaging. However, it remains unclear how physicians would value the availability of BBMs for AD in routine clinical practice. The investigators hypothesize that BBMs will benefit both patients and physicians in the diagnostic process within a memory clinic setting. This study aims to investigate clinical impact and diagnostic utility of blood-based biomarkers for AD in the diagnostic process of a memory clinic. The main objectives are to investigate change in diagnosis, diagnostic certainty and patient management, due to BBM results.

Interventions

• Plasma p-tau217 and neurofilament light chain results · DIAGNOSTIC_TEST

  Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion Criteria:

* Patient presents in memory clinic with cognitive complaints.
* The physician is concerned about underlying AD as etiology of the complaints.
* Adequate fluency in Dutch to understand informed consent procedure.

Exclusion Criteria:

* Age under 55.
* Previous biomarker-confirmed diagnosis of AD.
* Alcohol or drug abuse to such an extent that treatment would be advisable.
* Patient is incapacitated, and is not able to judge consequences of participation.

Sites (8)

• Amsterdam UMC, Amsterdam, North Holland, Netherlands · RECRUITING
• Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands · RECRUITING
• Flevoziekenhuis, Almere Stad, Netherlands · RECRUITING
• Spaarne Gasthuis, Haarlem, Netherlands · RECRUITING
• Tergooi MC, Hilversum, Netherlands · RECRUITING
• Frisius MC, Leeuwarden, Netherlands · RECRUITING
• Dijklander Ziekenhuis, Purmerend, Netherlands · RECRUITING
• Elisabeth-TweeSteden Ziekenhuis, Tilburg, Netherlands · NOT_YET_RECRUITING