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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Time from baseline to final diagnosis [Срок оценки: From enrolment to final diagnosis, assessed up to 100 months]
• Change in diagnosis [Срок оценки: 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 [Срок оценки: From enrolment to when BBM test results have been disclosed to the physician, assessed up to 3 months]

Вторичные конечные точки (5)

• Difference between the intervention group and the control group in use and timing of ancillary tests [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrolment to final diagnosis, assessed up to 100 months]
• Difference between the intervention group and the control group in patient management: referral [Срок оценки: 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 [Срок оценки: From enrolment to final diagnosis, assessed up to 100 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Нидерланды · 8 центров

• 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

Идентификаторы

NCT: NCT07680335 · 2025.0070 · 25-01-050817

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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