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

NCT07099001 | Completed

• 1 other identifier: Pro00083791
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease (AD); Cognitive Decline

Keywords

Patient Simulation

Outcome Measures

Primary Outcomes (2)

• QURE virtual patient clinical score difference

  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).

  Up to 12 months

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

  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).

  Up to 12 months

Secondary Outcomes (2)

• Variation in QURE virtual patient case baseline scores

  Up to 12 months

• Difference in QURE virtual patient case scores by case type

  Up to 12 months

Study Arms (2)

Control

NO INTERVENTION

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.

Intervention

EXPERIMENTAL

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.

Other: Educational materials on the Alzheimer's disease assay; Other: Alzheimer's disease assay results

Interventions

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.

Intervention

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• Beckman Coulter, Inc.: collaborator

Study Sites (1)

QURE Healthcare

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Trever Burgon, PhD

  QURE Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will enroll neurologists and dementia specialists practicing in the United States. Participants will be randomly assigned to either control or intervention arms upon enrollment. All eligible and consented participants will complete two rounds of three virtual patient simulations. The intervention arm participants will receive educational material about the novel Alzheimer's disease assay after round 1 of data collection. After a waiting period, intervention arm participants will receive the results of the AD assay at the appropriate point in the virtual patient simulation. Control arm participants will not receive results of the AD assay, but will have access to standard of care tools during both rounds of case administration.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 1, 2025
• Study Start: August 8, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)