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

NCT ID: NCT07099001

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-08
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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:

1. 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.

2. 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.

3. 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.

4. Determine whether the Alzheimer's disease assay results differentially impact treatment decisions for different patient types (use cases).

Conditions

Alzheimer Disease (AD); Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control

Control participants will complete two rounds of three virtual patient cases. In both rounds, control participants will have access to standard of care diagnostic tools. They will not receive the AD assay test results.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention

Intervention participants will complete two rounds of three virtual patient cases. In the first round, intervention participants will have access to standard of care diagnostic tools. They will then receive educational material about a novel AD assay. In the second round, they will automatically receive test results for the novel AD assay in addition to standard of care tools.

Group Type: EXPERIMENTAL

Educational materials on the Alzheimer's disease assay

Intervention Type: 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

Intervention Type: 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.

Interventions

Educational materials on the Alzheimer's disease assay

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.

Intervention Type: OTHER

Alzheimer's disease assay results

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beckman Coulter, Inc.

INDUSTRY

Sponsor Role: collaborator

Qure Healthcare, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Trever Burgon, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Trever Burgon, PhD

Role: PRINCIPAL_INVESTIGATOR

QURE Healthcare

Locations

QURE Healthcare

St Louis, Missouri, United States

Countries

United States

Other Identifiers

Pro00083791

Identifier Type: -

Identifier Source: org_study_id