Alzheimer Blood Biomarkers, Alzheimer's Disease (AD)
Conditions
Keywords
Randomised diagnostic trial
Brief 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
DIAGNOSTIC_TESTPlasma p-tau217 and neurofilament light chain results
Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.
Sponsors
Alzheimercentrum Amsterdam
Davos Alzheimer's Collaborative
Quanterix Corporation (in kind)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between the intervention group and the control group in use and timing of ancillary tests | From enrolment to final diagnosis, assessed up to 100 months | 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 | From enrolment to final diagnosis, assessed up to 100 months | 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 | From enrolment to final diagnosis, assessed up to 100 months | Duration of patient follow-up (reported in days) |
| Difference between the intervention group and the control group in patient management: referral | From enrolment to final diagnosis, assessed up to 100 months | Referral to another specialist or center (yes/no) |
| Difference between the intervention group and the control group in patient management: prescription of medication | From enrolment to final diagnosis, assessed up to 100 months | Prescription of medication (yes / no; if yes which medication) |
Countries
Netherlands
Contacts
CONTACTFloor Duits, PhD
Outcome results
None listed