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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 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

550

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Diagnose
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Usual care path
Blood-based biomarker results are not disclosed to the physician and/or patient, patient receives usual care and diagnostics
Experimental: 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
Diagnosetest: Plasma p-tau217 and neurofilament light chain results
Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Time from baseline to final diagnosis
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Difference between the intervention group and the control group in use and timing of ancillary tests
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Usefulness of AD BBMs per case as perceived by the physician
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Alzheimercentrum Amsterdam

Mitarbeiter

Davos Alzheimer's Collaborative
Quanterix Corporation (in kind)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

17. September 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2026

Studienabschluss (Geschätzt)

30. Juni 2027

Studienanmeldedaten

Zuerst eingereicht

4. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

2. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2025.0070
  • 25-01-050817 (Andere Kennung: EUDAMED)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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