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The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease (BRIDGE-AD2)

25. juni 2026 opdateret af: Floor Duits, Alzheimercentrum Amsterdam

The BRidge Towards Implementation of Blood-based Biomarkers to Enable Early and Accurate Diagnosis of Alzheimer's Disease (BRIDGE-AD2)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

550

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Holland
      • 's-Hertogenbosch, Holland
        • Rekruttering
        • Jeroen Bosch Ziekenhuis
        • Kontakt:
          • A van Strien, MD PhD
          • Telefonnummer: 0031735532000
        • Ledende efterforsker:
          • A van Strien, MD PhD
      • Almere Stad, Holland
        • Rekruttering
        • Flevoziekenhuis
        • Kontakt:
        • Ledende efterforsker:
          • M I Kester, MD PhD
      • Haarlem, Holland
        • Rekruttering
        • Spaarne Gasthuis
        • Kontakt:
        • Ledende efterforsker:
          • N SM Schoonenboom, MD PhD
      • Hilversum, Holland
        • Rekruttering
        • Tergooi MC
        • Kontakt:
        • Ledende efterforsker:
          • S S Staekenborg, MD PhD
      • Leeuwarden, Holland
        • Rekruttering
        • Frisius MC
        • Kontakt:
        • Ledende efterforsker:
          • N A Verwey, MD PhD
      • Purmerend, Holland
        • Rekruttering
        • Dijklander Ziekenhuis
        • Kontakt:
        • Ledende efterforsker:
          • L AR Zwart, MD PhD
      • Tilburg, Holland
        • Ikke rekrutterer endnu
        • Elisabeth-TweeSteden Ziekenhuis
        • Kontakt:
          • H P Aben, MD PhD
          • Telefonnummer: 0031132210000
          • E-mail: h.aben@etz.nl
        • Ledende efterforsker:
          • H P Aben, MD PhD
    • North Holland
      • Amsterdam, North Holland, Holland, 1081HV
        • Rekruttering
        • Amsterdam UMC
        • Kontakt:
        • Ledende efterforsker:
          • F H Duits, MD PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Usual care path
Blood-based biomarker results are not disclosed to the physician and/or patient, patient receives usual care and diagnostics
Eksperimentel: Blood-based biomarker results are made available to the physician
In addition to usual care and diagnostics, blood-based biomarker results are sent to the physician who can disclose the results to the patient
Diagnostisk test: Plasma p-tau217 and neurofilament light chain results
Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time from baseline to final diagnosis
Tidsramme: From enrolment to final diagnosis, assessed up to 100 months
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
Tidsramme: 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.
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
Tidsramme: 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.
From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference between the intervention group and the control group in use and timing of ancillary tests
Tidsramme: 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.
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
Tidsramme: 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).
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
Tidsramme: From enrolment to final diagnosis, assessed up to 100 months
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
Tidsramme: From enrolment to final diagnosis, assessed up to 100 months
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
Tidsramme: From enrolment to final diagnosis, assessed up to 100 months
Prescription of medication (yes / no; if yes which medication)
From enrolment to final diagnosis, assessed up to 100 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Usefulness of AD BBMs per case as perceived by the physician
Tidsramme: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months

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.
From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months
Patients' motivation for participation
Tidsramme: After the blood test is performed, assessed up to 3 months
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
Tidsramme: After the blood test is performed, assessed up to 3 months

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)
After the blood test is performed, assessed up to 3 months
Patient's understanding of the BBM results
Tidsramme: After the blood test is performed, assessed up to 3 months
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
Tidsramme: After the blood test is performed, assessed up to 3 months
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
Tidsramme: After the blood test is performed, assessed up to 3 months
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
Tidsramme: From enrolment to final diagnosis, assessed up to 100 months
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
Tidsramme: From enrolment to final diagnosis, assessed up to 100 months
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
Tidsramme: Up to 10 years after study completion
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alzheimercentrum Amsterdam

Samarbejdspartnere

Davos Alzheimer's Collaborative
Quanterix Corporation (in kind)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

17. september 2025

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

4. juni 2026

Først indsendt, der opfyldte QC-kriterier

25. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025.0070
  • 25-01-050817 (Anden identifikator: EUDAMED)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Plasma p-tau217 and neurofilament light chain results

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