@article{5bd0ba14c46c473881187b52825a23f0,
title = "Using Alzheimer's disease blood tests to accelerate clinical trial enrollment",
abstract = "Introduction: Screening potential participants in Alzheimer's disease (AD) clinical trials with amyloid positron emission tomography (PET) is often time consuming and expensive. Methods: A web-based application was developed to model the time and financial cost of screening for AD clinical trials. Four screening approaches were compared; three approaches included an AD blood test at different stages of the screening process. Results: The traditional screening approach using only amyloid PET was the most time consuming and expensive. Incorporating an AD blood test at any point in the screening process decreased both the time and financial cost of trial enrollment. Improvements in AD blood test accuracy over currently available tests only marginally increased savings. Use of a high specificity cut-off may improve the feasibility of screening with only an AD blood test. Discussion: Incorporating AD blood tests into screening for AD clinical trials may reduce the time and financial cost of enrollment. HIGHLIGHTS: The time and cost of enrolling participants in Alzheimer's disease (AD) clinical trials were modeled. A web-based application was developed to enable evaluation of key parameters. AD blood tests may decrease the time and financial cost of clinical trial enrollment. Improvements in AD blood test accuracy only marginally increased savings. Use of a high specificity cut-off may enable screening with only an AD blood test.",
keywords = "Shiny app, amyloid positron emission tomography, blood tests, blood-based biomarkers, clinical trials, cost, economics, false negative, false positive, modeling, screening, screening approaches, time of enrollment",
author = "Schindler, {Suzanne E.} and Yan Li and Melody Li and Alyssa Despotis and Ethan Park and Liberty Vittert and Hamilton, {Barton H.} and Womack, {Kyle B.} and Benjamin Saef and Holtzman, {David M.} and Morris, {John C.} and Bateman, {Randall J.} and Gupta, {Mahendra R.}",
note = "Funding Information: The authors would like to express our gratitude to the research volunteers who participate in AD clinical trials and their supportive families. The authors would like to thank Dr B. Joy Snider and Sonia Simons for assistance in gathering information on clinical trials at Washington University. This study was supported by National Institutes of Health (NIH) grants R01AG070941 (S.E. Schindler), RF1AG061900 (R.J. Bateman, PI), R56AG061900 (R.J. Bateman, PI), P30AG066444 (J.C. Morris, PI), P01AG003991 (J.C. Morris, PI), P01AG026276 (J.C. Morris, PI), U19AG032438 (J.C. Morris, PI), and U19AG024904 (J.C. Morris, PI). Funding Information: The authors would like to express our gratitude to the research volunteers who participate in AD clinical trials and their supportive families. The authors would like to thank Dr B. Joy Snider and Sonia Simons for assistance in gathering information on clinical trials at Washington University. This study was supported by National Institutes of Health (NIH) grants R01AG070941 (S.E. Schindler), RF1AG061900 (R.J. Bateman, PI), R56AG061900 (R.J. Bateman, PI), P30AG066444 (J.C. Morris, PI), P01AG003991 (J.C. Morris, PI), P01AG026276 (J.C. Morris, PI), U19AG032438 (J.C. Morris, PI), and U19AG024904 (J.C. Morris, PI). Publisher Copyright: {\textcopyright} 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.",
year = "2023",
month = apr,
doi = "10.1002/alz.12754",
language = "English",
volume = "19",
pages = "1175--1183",
journal = "Alzheimer's and Dementia",
issn = "1552-5260",
number = "4",
}