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

NCT07099001 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-01-07

No results posted yet for this study

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

Interventions

OTHER

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.

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.

Sponsors & Collaborators

  • Beckman Coulter, Inc.

    collaborator INDUSTRY
  • Qure Healthcare, LLC

    lead INDUSTRY

Principal Investigators

  • Trever Burgon, PhD · QURE Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-08
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07099001 on ClinicalTrials.gov