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NCT Number: NCT07099001

Establishing Clinical Utility Evidence for a Novel Alzheimer's Disease Blood-Based Biomarker Assay

This is a national-level research study of neurologists and dementia specialists. The purpose of this study is to assess the clinical evaluation and management recommendations made by practicing providers for patient simulations with symptoms of cognitive decline.

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Key information

Conditions

Alzheimer Disease (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Decline Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QURE Healthcare

St Louis, Missouri, 63110, United States

About this study

QURE Healthcare will recruit a nationwide sample of neurologists and dementia specialists to assess the clinical evaluation and management potential of a novel diagnostic tool. The results of this study are expected to contribute to improved quality of care for patients with symptoms of Alzheimer's disease. Findings from this study will be submitted to a national journal for peer-reviewed publication. This study plans to enroll at least 150 healthcare providers.

This study will evaluate the clinical utility of Alzheimer's disease assay by analyzing improvement in the quality of physician decision-making regarding patients with symptoms of Alzheimer's disease, using a validated patient-simulation-based measurement approach, to achieve the following:

  • Measure variation in clinical decisions among practicing neurologists, specifically in how they detect, measure, and manage Alzheimer's disease in patients with symptoms and/or risk factors of cognitive decline.
  • Determine whether education on the Alzheimer's disease assay with accompanying test results leads to changes in clinical decision-making with regard to follow-up testing (e.g., CSF analysis, PET imaging), diagnostic accuracy, and treatment recommendations.
  • Model whether the use of the Alzheimer's disease assay leads to higher-value and/or lower-cost care decisions (including follow-up testing, diagnostics, and treatment) that can lead to more efficient care.
  • Determine whether the Alzheimer's disease assay results differentially impact treatment decisions for different patient types (use cases).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Board-certified in neurology for at least two years (and no more than 35 years
  • Average at least 20 hours per week of clinical and patient care duties over the past six months
  • Routinely evaluate patients at risk for Alzheimer's disease
  • Practicing in the United States
  • Able to read English
  • Access to the internet
  • Not participating in a clinical research study of the AD assay
  • Informed, signed, and voluntarily consented to participate in this study

Exclusion criteria

  • Board-certified in neurology for less than two years
  • Board certification in neurology over 35 years ago
  • Unable to read English
  • Unable to access the internet
  • Not practicing in the United States
  • Not averaging at least 20 hours per week of clinical or patient care duties over the past six months
  • Participating in a clinical research study of the AD assay
  • Do not voluntarily consent to participate in this study

Treatment and study plan

Educational materials on the Alzheimer's disease assay

Other

Between Round 1 and Round 2 virtual patient case administration, Intervention participants will receive educational materials describing the clinical validation and use cases of the Alzheimer's disease assay. These materials will approximate the type of information physicians would receive to introduce them to the Alzheimer's disease assay and may be comprised of a slide deck, fact sheet, sample test report, and/or example case scenarios.

Alzheimer's disease assay results

Other

Within each of their virtual patient cases in Round 2 of case administration, Intervention participants will receive Alzheimer's disease assay results at the clinically appropriate point for each case.

Primary outcomes

  1. QURE virtual patient clinical score difference

    Time frame: Up to 12 months

    Difference-in-differences regression analysis between the control and the intervention groups' diagnosis and treatment of symptoms of cognitive decline, as measured by the participants' diagnostic and treatment case scores. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes).

  2. Change in follow-up decisions (QURE scored-based) after receiving AD assay results

    Time frame: Up to 12 months

    Assessing changes in follow-up decisions (via QURE case domain scores) among intervention providers after they receive the results of the novel AD assay in the second round of case administration. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes).

Secondary outcomes

  1. Variation in QURE virtual patient case baseline scores

    Time frame: Up to 12 months

    Participants completing QURE virtual patients receive scores based upon the quality of care they provide. In each QURE case, every participants' care recommendations are evaluated against evidence-based care scoring criteria, which can range from 0% to 100% (with higher percentages indicating better outcomes). This measure will assess the baseline levels of variation in the care of virtual patients with symptoms of cognitive decline among all participants, including by use case types.

  2. Difference in QURE virtual patient case scores by case type

    Time frame: Up to 12 months

    Difference in the overall quality scores between control and intervention participants. The overall score is calculated as the percent of correct (evidence-based) minus incorrect (low-value) decisions divided by the total number of correct decisions in a QURE virtual patient case. Differences in scores between case types across rounds will be assessed to determine which use cases show the most improvement.

Sponsors and collaborators

Lead sponsor

Qure Healthcare, LLC

Industry

Collaborators

  • Beckman Coulter, Inc.

Registry information

Official study title

Establishing Clinical Utility Evidence for a Novel Alzheimer's Disease Blood-Based Biomarker Assay: A QURE Virtual Patient Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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