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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 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

550

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Olanda
      • 's-Hertogenbosch, Olanda
        • Reclutamento
        • Jeroen Bosch Ziekenhuis
        • Contatto:
          • A van Strien, MD PhD
          • Numero di telefono: 0031735532000
        • Investigatore principale:
          • A van Strien, MD PhD
      • Almere Stad, Olanda
        • Reclutamento
        • Flevoziekenhuis
        • Contatto:
        • Investigatore principale:
          • M I Kester, MD PhD
      • Haarlem, Olanda
        • Reclutamento
        • Spaarne Gasthuis
        • Contatto:
        • Investigatore principale:
          • N SM Schoonenboom, MD PhD
      • Hilversum, Olanda
        • Reclutamento
        • Tergooi MC
        • Contatto:
        • Investigatore principale:
          • S S Staekenborg, MD PhD
      • Leeuwarden, Olanda
        • Reclutamento
        • Frisius MC
        • Contatto:
        • Investigatore principale:
          • N A Verwey, MD PhD
      • Purmerend, Olanda
        • Reclutamento
        • Dijklander Ziekenhuis
        • Contatto:
        • Investigatore principale:
          • L AR Zwart, MD PhD
      • Tilburg, Olanda
        • Non ancora reclutamento
        • Elisabeth-TweeSteden Ziekenhuis
        • Contatto:
          • H P Aben, MD PhD
          • Numero di telefono: 0031132210000
          • Email: h.aben@etz.nl
        • Investigatore principale:
          • H P Aben, MD PhD
    • North Holland
      • Amsterdam, North Holland, Olanda, 1081HV
        • Reclutamento
        • Amsterdam UMC
        • Contatto:
        • Investigatore principale:
          • F H Duits, MD PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Diagnostico
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Nessun intervento: Usual care path
Blood-based biomarker results are not disclosed to the physician and/or patient, patient receives usual care and diagnostics
Sperimentale: 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
Test diagnostico: Plasma p-tau217 and neurofilament light chain results
Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time from baseline to final diagnosis
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference between the intervention group and the control group in use and timing of ancillary tests
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Usefulness of AD BBMs per case as perceived by the physician
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Alzheimercentrum Amsterdam

Collaboratori

Davos Alzheimer's Collaborative
Quanterix Corporation (in kind)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

17 settembre 2025

Completamento primario (Stimato)

31 dicembre 2026

Completamento dello studio (Stimato)

30 giugno 2027

Date di iscrizione allo studio

Primo inviato

4 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

25 giugno 2026

Primo Inserito (Effettivo)

2 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

25 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2025.0070
  • 25-01-050817 (Altro identificatore: EUDAMED)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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