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

Condition(s) studied

Investigational drug(s) / intervention(s)

Plasma p-tau217 and neurofilament light chain results: Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.

Study 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.

Eligibility

Primary outcome measure(s)

• Time from baseline to final diagnosis — From enrolment to final diagnosis, assessed up to 100 months
  The time from baseline visit to final diagnosis will be reported in days.
• Change in diagnosis — From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
  Comparison between the diagnosis (syndrome diagnosis and etiology) before and after BBM testing. Change in diagnosis will be reported as yes/no.
• Change in physician's confidence in diagnosis — From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
  Comparison between physician's confidence in diagnosis before and after BBM testing within the intervention group. Physician's confidence will be measured on a 7-point Likert scale, with 1 being very uncertain and 7 being very certain.

Trial sites (8)

More Alzheimercentrum Amsterdam trials in the Netherlands