Objective: The objective of this study was to assess clinical decision-making associated with the use of a multi-analyte blood biomarker (BBM) test among patients presenting with signs or symptoms of mild cognitive impairment or dementia. Methods: The Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey (NCT06025877) study evaluated the clinical utility of the PrecivityAD2™ blood test in a prospective, single cohort of 203 patients presenting with symptoms of Alzheimer’s disease (AD) or other causes of cognitive decline across 12 memory specialists. The PrecivityAD2 blood test (C2N Diagnostics, St. Louis, MO) combines the plasma Aβ42/Aβ40 ratio and the p-tau217/np-tau217 ratio (%p-tau217) measurements in a statistical algorithm to yield an Amyloid Probability Score 2 (APS2) that informs on the likelihood of brain amyloid plaques. After receiving the BBM test results, clinicians completed surveys on management strategies for each patient. Results: Patients had a median age of 74, 53% were female, and 28% were traditionally under-represented in Black, Hispanic, and Asian groups. The composite primary endpoint, defined as a change in AD diagnostic certainty, drug therapy, or additional brain amyloid evaluation pre- and post-BBM testing, was 75% (p < 0.0001 versus the pre-specified threshold of 20% clinically meaningful change). Anti-AD medication orders decreased among negative APS2 patients and increased among positive APS2 patients (p < 0.0001). Additional brain amyloid testing decreased among negative APS2 patients (p < 0.0001). Conclusions: This blood biomarker test can help memory specialists guide patients to anti-AD therapies as well as rule out AD to allow for other diagnostic considerations.

Background/Objectives: A high-performing blood biomarker (BBM) test for Alzheimer’s disease (AD) represents an accurate, accessible, and scalable tool to aid healthcare professionals (HCPs) evaluating patients presenting with signs or symptoms of mild cognitive impairment (MCI) or dementia. However, implementation of AD blood tests into clinical practice has not been extensively evaluated. The objective of this study was to assess the implementation of the multi-analyte PrecivityAD2™ blood test (C2N Diagnostics, LLC, St. Louis, MO, USA) into the clinical workflow of memory care clinics. Methods: A total of 8 HCPs (neurologists, geriatricians, geriatric psychiatrists) who served as site directors from 8 outpatient sites that evaluated 203 cognitively symptomatic patients were included in this sub-study of the real-world QUIP II Study (NCT06025877). Implementation of this blood test was assessed through surveying these HCPs using published frameworks including the Technology Acceptance Model, net promoter score, and forced choice preference questions. These assessments were analyzed using Wilcoxon signed-rank test, Fisher’s Exact test, and Wilcoxon signed-rank test, respectively. Results: HCPs reported acceptance scores that averaged 9.6 out of 10 (p < 0.0001, effect size 0.840): the test’s contribution to clinical decision-making as well as the ease of understanding test results received the highest ratings. The net promoter score was 75 (p < 0.0001), exceeding the typical benchmark of 30 reported as good levels of satisfaction in healthcare settings. The APS2 results and individual blood analyte results were rated with similar preference around their roles in HCP clinical decision-making. Conclusions: The results indicate early evidence of user acceptance and recognition by HCPs that this AD blood test can personalize the clinical care pathway for evaluating cognitively symptomatic patients.