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

Qure Healthcare

Status: Completed

Conditions: Cognitive Decline; Alzheimer Disease (AD)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07099001

Pro00083791

Details and patient eligibility

About

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.

Full 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).

Enrollment: 178 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

Control

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Other: Alzheimer's disease assay results

Other: Educational materials on the Alzheimer's disease assay