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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. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

550

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Diagnostický
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Žádný zásah: Usual care path
Blood-based biomarker results are not disclosed to the physician and/or patient, patient receives usual care and diagnostics
Experimentální: 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
Diagnostický test: Plasma p-tau217 and neurofilament light chain results
Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Time from baseline to final diagnosis
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Difference between the intervention group and the control group in use and timing of ancillary tests
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Usefulness of AD BBMs per case as perceived by the physician
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Alzheimercentrum Amsterdam

Spolupracovníci

Davos Alzheimer's Collaborative
Quanterix Corporation (in kind)

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

17. září 2025

Primární dokončení (Odhadovaný)

31. prosince 2026

Dokončení studie (Odhadovaný)

30. června 2027

Termíny zápisu do studia

První předloženo

4. června 2026

První předloženo, které splnilo kritéria kontroly kvality

25. června 2026

První zveřejněno (Aktuální)

2. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

2. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 2025.0070
  • 25-01-050817 (Jiný identifikátor: EUDAMED)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Alzheimerova choroba (AD)

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Podmínky

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