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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
550
Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.
Amsterdam UMC
Amsterdam, North Holland, Netherlands
RECRUITINGJeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
RECRUITINGFlevoziekenhuis
Almere Stad, Netherlands
RECRUITINGSpaarne Gasthuis
Haarlem, Netherlands
RECRUITINGTergooi MC
Hilversum, Netherlands
RECRUITINGFrisius MC
Leeuwarden, Netherlands
RECRUITINGDijklander Ziekenhuis
Purmerend, Netherlands
RECRUITINGElisabeth-TweeSteden Ziekenhuis
Tilburg, Netherlands
NOT_YET_RECRUITINGTime from baseline to final diagnosis
The time from baseline visit to final diagnosis will be reported in days.
Time frame: From enrolment to final diagnosis, assessed up to 100 months
Change in diagnosis
Comparison between the diagnosis (syndrome diagnosis and etiology) before and after BBM testing. Change in diagnosis will be reported as yes/no.
Time frame: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
Change in physician's confidence in diagnosis
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.
Time frame: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
Difference between the intervention group and the control group in use and timing of ancillary tests
Use of ancillary tests (yes/no), including neuropsychological evaluation, brain CT, brain MRI, CSF biomarker analysis, amyloid PET, FDG PET, DaT-SPECT, EEG/MEG, genetic testing, and speech therapy consultation. If performed, the timing in days from enrollment will be reported.
Time frame: From enrolment to final diagnosis, assessed up to 100 months
Concordance of BBM results with the presence of AD pathology according to CSF or amyloid PET
Concordance will be defined as the percentage of BBM results (positive or negative) that is concordant with CSF or amyloid PET results (positive or negative).
Time frame: From enrolment to final diagnosis, assessed up to 100 months
Difference between the intervention group and the control group in patient management: follow-up duration
Duration of patient follow-up (reported in days)
Time frame: From enrolment to final diagnosis, assessed up to 100 months
Difference between the intervention group and the control group in patient management: referral
Referral to another specialist or center (yes/no)
Time frame: From enrolment to final diagnosis, assessed up to 100 months
Difference between the intervention group and the control group in patient management: prescription of medication
Prescription of medication (yes / no; if yes which medication)
Time frame: From enrolment to final diagnosis, assessed up to 100 months
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