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Related Experiment Video

Updated: Sep 7, 2025

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Biomarkers and Mindfulness: A Way Forward.

Alan J Lerner1,2

  • 1Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, OH, USA.

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New non-invasive blood tests for Alzheimer's disease (AD) are emerging, like the PrecivityADtrademark test. Careful consideration of their use and communication is crucial to avoid misinterpretation and ensure patient safety.

Keywords:
Alzheimer’s diseaseamyloidbiomarkersdementiamindfulnessplasmaprediction

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Area of Science:

  • Neurology
  • Biomarker Discovery
  • Clinical Diagnostics

Background:

  • Non-invasive tests for detecting cerebral amyloidosis and Alzheimer's disease (AD) are becoming available for clinical use.
  • The PrecivityADtrademark test is a plasma-based assay that provides an Amyloid Probability score for brain amyloid accumulation.

Purpose of the Study:

  • To address concerns raised by the AGREEDementia consortium regarding the optimal use and communication of PrecivityADtrademark test results.
  • To emphasize the need for careful application of dementia biomarker tests within the FDA's biomarker context of use framework.

Main Methods:

  • Review of current trends in non-invasive AD biomarker testing.
  • Discussion of potential challenges and unintended consequences of biomarker test integration into electronic medical records.
  • Consideration of stakeholder consensus on test interpretation and limitations.

Main Results:

  • PrecivityADtrademark demonstrates high sensitivity and specificity for brain amyloid, but may yield inconclusive results.
  • Potential for mislabeling patients exists if tests are used inappropriately or interpreted by inadequately trained personnel.
  • Biomarker tests can stratify AD risk but require careful contextual understanding.

Conclusions:

  • Mindful application and clear communication strategies are essential for new dementia biomarker tests.
  • A consensus among stakeholders is needed to define the appropriate uses and limitations of these tests.
  • Adherence to regulatory frameworks, like the FDA's context of use, is vital to prevent unintended consequences.