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
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
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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