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Recruiting NCT07680335

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

No phase Interventional Alzheimer Blood Biomarkers Alzheimer's Disease (AD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plasma p-tau217 and neurofilament light chain results.
Who it may be relevant to
Registry conditions: Alzheimer Blood Biomarkers, Alzheimer's Disease (AD). Basic parameters: from 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test Plasma p-tau217 and neurofilament light chain results
    Results of the Quanterix Simoa ALZpath p-tau217 and Quanterix Simoa NfL assay.

Primary outcome measures

  • Time from baseline to final diagnosis [Time frame: From enrolment to final diagnosis, assessed up to 100 months]
  • Change in diagnosis [Time frame: 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 [Time frame: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months]
Secondary outcome measures (5)
  • Difference between the intervention group and the control group in use and timing of ancillary tests [Time frame: 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 [Time frame: 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 [Time frame: From enrolment to final diagnosis, assessed up to 100 months]
  • Difference between the intervention group and the control group in patient management: referral [Time frame: 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 [Time frame: From enrolment to final diagnosis, assessed up to 100 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 8 centers
  • Amsterdam UMC — Amsterdam
  • Jeroen Bosch Ziekenhuis — 's-Hertogenbosch
  • Flevoziekenhuis — Almere Stad
  • Spaarne Gasthuis — Haarlem
  • Tergooi MC — Hilversum
  • Frisius MC — Leeuwarden
  • Dijklander Ziekenhuis — Purmerend
  • Elisabeth-TweeSteden Ziekenhuis — Tilburg

Identifiers

NCT: NCT07680335 · 2025.0070 · 25-01-050817

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗