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.
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.
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.
Parallel
Plasma p-tau217 and neurofilament light chain results
Diagnostic testResults of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.
Time from baseline to final diagnosis
The time from baseline visit to final diagnosis will be reported in days.
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.
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.
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.
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).
Difference between the intervention group and the control group in patient management: follow-up duration
Duration of patient follow-up (reported in days)
Difference between the intervention group and the control group in patient management: referral
Referral to another specialist or center (yes/no)
Usefulness of AD BBMs per case as perceived by the physician
In the intervention group: Usefulness as perceived by the physician measured on a 5-point Likert scale with 1 being extremely unuseful and 5 being extremely useful. In the control group: Hypothetical usefulness (yes/no/maybe) as perceived by the physician in case the BBM results would have been received. In all cases: Desireability of the blood test being performed (yes/no) as perceived by the physician prior to receiving BBM results.
Patients' motivation for participation
Participants will be asked to indicate their motivation for participation.
Patients' experience with receiving or not receiving BBM results
Intervention group: Experience of receiving BBM results will be assessed by asking participants: * Whether not receiving the results would have been preferred (yes/no/I do not know) * Whether receiving the results had positive consequences (yes/no) * Whether receiving the results had negative consequences (yes/no) In the control group: experience of not receiving BBM results will be assessed by asking participants: \- Whether receiving the results would have been preferred (yes/no/I do not know)
Patient's understanding of the BBM results
Participant's understanding will be assessed by asking participants whether the diagnosis changed after receiving BBM results. If yes, participants will be asked to indicate the initial diagnosis. Additionally, participants will be asked to explain, in their own words, what the BBM results meant.
Click on the lead sponsor to view all of their trials.
Alzheimercentrum Amsterdam
Lead sponsor
Davos Alzheimer's Collaborative
Collaborator
Quanterix Corporation (in kind)
Collaborator
