Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study
<b>Objective</b>: 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. <b>Methods</b>: The Quality Im...
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2025-01-01
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| Online Access: | https://www.mdpi.com/2075-4418/15/2/167 |
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| author | Mark Monane Demetrius M. Maraganore Robert M. Carlile Kim G. Johnson David A. Merrill Darren R. Gitelman Kenneth S. Sharlin Lawren A. VandeVrede Kristi K. George Jimin Wang Tim West Leslie Jacobs Philip B. Verghese Joel B. Braunstein |
| author_facet | Mark Monane Demetrius M. Maraganore Robert M. Carlile Kim G. Johnson David A. Merrill Darren R. Gitelman Kenneth S. Sharlin Lawren A. VandeVrede Kristi K. George Jimin Wang Tim West Leslie Jacobs Philip B. Verghese Joel B. Braunstein |
| author_sort | Mark Monane |
| collection | DOAJ |
| description | <b>Objective</b>: 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. <b>Methods</b>: 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. <b>Results</b>: 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% (<i>p</i> < 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 (<i>p</i> < 0.0001). Additional brain amyloid testing decreased among negative APS2 patients (<i>p</i> < 0.0001). <b>Conclusions:</b> 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. |
| format | Article |
| id | doaj-art-8bbdbff2c1f647839800061f091b8645 |
| institution | Kabale University |
| issn | 2075-4418 |
| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-8bbdbff2c1f647839800061f091b86452025-01-24T13:28:58ZengMDPI AGDiagnostics2075-44182025-01-0115216710.3390/diagnostics15020167Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey StudyMark Monane0Demetrius M. Maraganore1Robert M. Carlile2Kim G. Johnson3David A. Merrill4Darren R. Gitelman5Kenneth S. Sharlin6Lawren A. VandeVrede7Kristi K. George8Jimin Wang9Tim West10Leslie Jacobs11Philip B. Verghese12Joel B. Braunstein13C<sub>2</sub>N Diagnostics, LLC, 4340 Duncan Avenue, St. Louis, MO 63110, USADepartment of Neurology, Tulane University School of Medicine, New Orleans, LA 70112, USAPalmetto Primary Care Physicians, Summerville, SC 29486, USADepartment of Neurology, Duke University School of Medicine, Durham, NC 27710, USAPacific Neuroscience Institute, Santa Monica, CA 90404, USAAdvocate Lutheran General Hospital, Park Ridge, IL 60068, USASharlin Health and Neurology, Ozark, MO 65721, USAUCSF Weill Institute for Neurosciences, San Francisco, CA 94103, USAJWM Neurology, Indianapolis, IN 46256, USAStat4ward, Pittsburgh, PA 15238, USAC<sub>2</sub>N Diagnostics, LLC, 4340 Duncan Avenue, St. Louis, MO 63110, USAC<sub>2</sub>N Diagnostics, LLC, 4340 Duncan Avenue, St. Louis, MO 63110, USAC<sub>2</sub>N Diagnostics, LLC, 4340 Duncan Avenue, St. Louis, MO 63110, USAC<sub>2</sub>N Diagnostics, LLC, 4340 Duncan Avenue, St. Louis, MO 63110, USA<b>Objective</b>: 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. <b>Methods</b>: 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. <b>Results</b>: 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% (<i>p</i> < 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 (<i>p</i> < 0.0001). Additional brain amyloid testing decreased among negative APS2 patients (<i>p</i> < 0.0001). <b>Conclusions:</b> 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.https://www.mdpi.com/2075-4418/15/2/167Alzheimer’s diseaseblood biomarkerdiagnosisclinical decision-makingclinical utilitymemory care specialists |
| spellingShingle | Mark Monane Demetrius M. Maraganore Robert M. Carlile Kim G. Johnson David A. Merrill Darren R. Gitelman Kenneth S. Sharlin Lawren A. VandeVrede Kristi K. George Jimin Wang Tim West Leslie Jacobs Philip B. Verghese Joel B. Braunstein Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study Diagnostics Alzheimer’s disease blood biomarker diagnosis clinical decision-making clinical utility memory care specialists |
| title | Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study |
| title_full | Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study |
| title_fullStr | Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study |
| title_full_unstemmed | Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study |
| title_short | Clinical Utility of an Alzheimer’s Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study |
| title_sort | clinical utility of an alzheimer s disease blood test among cognitively impaired patients results from the quality improvement precivityad2 quip ii clinician survey study |
| topic | Alzheimer’s disease blood biomarker diagnosis clinical decision-making clinical utility memory care specialists |
| url | https://www.mdpi.com/2075-4418/15/2/167 |
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