Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 25-01-050817 | Other Identifier | EUDAMED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Davos Alzheimer's Collaborative | UNKNOWN |
| Quanterix Corporation (in kind) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care path | No Intervention | Blood-based biomarker results are not disclosed to the physician and/or patient, patient receives usual care and diagnostics | |
| Blood-based biomarker results are made available to the physician | Experimental | In addition to usual care and diagnostics, blood-based biomarker results are sent to the physician who can disclose the results to the patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma p-tau217 and neurofilament light chain results | Diagnostic Test | Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time from baseline to final diagnosis | The time from baseline visit to final diagnosis will be reported in days. | 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. | 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. | From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrolment to final diagnosis, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Floor Duits, PhD | Contact | 020 - 4440816 | f.duits@amsterdamumc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1081HV | Netherlands |
There are plans to share IPD through the ADDI platform, however a contract or data sharing agreement has not yet been established. Therefore it is not yet clear which specific IPD will be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). | 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) | 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) | 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) | From enrolment to final diagnosis, assessed up to 100 months |
| From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months |
| Patients' motivation for participation | Participants will be asked to indicate their motivation for participation. | After the blood test is performed, assessed up to 3 months |
| Patients' experience with receiving or not receiving BBM results | Intervention group: Experience of receiving BBM results will be assessed by asking participants:
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) | After the blood test is performed, assessed up to 3 months |
| 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. | After the blood test is performed, assessed up to 3 months |
| Patients' satisfaction with the provision of information | In case the results were disclosed to the patient: Satisfaction will be assessed by rating their agreement with 2 statements on a 5-point agree/disagree scale with 1 being strongly disagree and 5 being strongly agree. | After the blood test is performed, assessed up to 3 months |
| Patients' satisfaction with the decision to participate | In all cases: Satisfaction will be assessed by asking participants to rate their agreement with 4 statements on a 5-point decision regret scale with 1 being strongly disagree and 5 being strongly agree. | After the blood test is performed, assessed up to 3 months |
| Cognitive performance measured by the MOCA | Total scores of the Montreal Cognitive Assessment (MoCA) will be registered, if performed during clinical work-up. Scores range from 0 to 30. | From enrolment to final diagnosis, assessed up to 100 months |
| Cognitive performance measured by the MMSE | Total scores of the Mini-Mental State Examination (MMSE) will be registered, if performed during clinical work-up. Scores range from 0 to 30. | From enrolment to final diagnosis, assessed up to 100 months |
| Survival | Information on survival will be requested from Statistics Netherlands (Centraal Bureau voor de Statistiek; CBS), provided informed consent has been given for this (optional / separate question in ICF). | Up to 10 years after study completion |
| Jeroen Bosch Ziekenhuis | Recruiting | 's-Hertogenbosch | Netherlands |
|
| Flevoziekenhuis | Recruiting | Almere Stad | Netherlands |
|
| Spaarne Gasthuis | Recruiting | Haarlem | Netherlands |
|
| Tergooi MC | Recruiting | Hilversum | Netherlands |
|
| Frisius MC | Recruiting | Leeuwarden | Netherlands |
|
| Dijklander Ziekenhuis | Recruiting | Purmerend | Netherlands |
|
| Elisabeth-TweeSteden Ziekenhuis | Not yet recruiting | Tilburg | Netherlands |
|
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided