Description
Diagnosing Alzheimer s disease (AD) and other neurodegenerative diseases such as dementia with Lewy bodies (DLB), Parkinson s disease (PD), frontotemporal dementia (FTD), and amyotrophic lateral sclerosis poses significant challenges to healthcare, often resulting in delayed or inadequate patient care. Additionally many of the conditions have overlapping phenotypes or pathologies which makes it difficult to identify single pathological contributions.
Despite the high prevalence of mild cognitive impairment and dementia and other neurodegenerative diseases, up to 92% of patients with early cognitive decline remain undiagnosed or misdiagnosed in healthcare settings. Moreover, the scarcity of neurological specialists in the US exacerbates the situation, with many patients failing to access specialty care, and those who are referred experience prolonged wait times. Consequently, because the majority of AD neuroimaging or cerebrospinal fluid (CSF) biomarker testing takes place in specialty care settings (i.e., secondary or tertiary care), only a small fraction of patients with cognitive impairment receives such testing.
Traditional biomarker modalities for confirming neuro pathology in conditions such as AD, PD, DLB and FTD include positron emission tomography (PET) or a lumbar puncture to collect CSF to measure concentrations of A , tau and others. PET and CSF biomarkers have a number of shortcomings including high cost, limited accessibility, and perceived invasiveness, making them unsuitable for widespread use across care settings. Recent advancements in blood-based biomarker (BBM) tests for AD offer a promising alternative. These tests are less costly, more accessible, more acceptable to patients, and more practical for serial collection to monitor disease progression.
In PD and DLB, there are emerging CSF assays for alpha-synuclein but a BBBM for PD or DLB has not emerged. There are BBBMs being considered for FTD and PSP but none have been commercially approved.
Blood-based biomarkers (BBM) for Alzheimer s disease (AD) and other neurodegenerative diseases are being increasingly used in clinical practice to support clinical diagnosis. In contrast to traditional diagnostic modalities, such as amyloid positron emission tomography and cerebrospinal fluid biomarkers, BBMs offer a more accessible and lower cost alternative for AD biomarker testing. Their unique scalability addresses the anticipated surge in demand for biomarker testing with the emergence of disease-modifying treatments that require confirmation of amyloid pathology. The major change in the field is that the detection assays have improved from nanomolar (10-9) to femtomolar (10-15) which allows for detection of proteins previously not considered measurable in the blood spaces.
The clinical integration of blood-based biomarkers (BBBMs) for AD and other neurodegenerative diseases holds promise in enabling early detection of pathology and timely intervention. Similar investigations are being considered for other neurodegenerative diseases. However, several critical considerations, such as limited understanding of BBM test characteristics, insufficient evidence on BBM performance across diverse populations, and how individual test parameters performed on different assay platforms can be meaningfully compared.
This book summarizes the current assays ready for clinical use or in development for neurodegenerative diseases including AD, PD, DLB, PSP, FTD and ALS, from assay technologies to clinical applications.
As starting from technologies in Chapter 1, seventeen ultra-sensitive assay platforms are introduced. The details of detecting mechanism, feature of assay, plasma preparation, commercialization, and key specifications of assay kits are illustrated for each assay platform. Readers can have comprehensive understanding about insights of these complicated technologies for assaying blood-b
Chapter 1: Ultra-sensitive Assay Technologies.- Chapter 2: Roles of Plasma Preparation in Biomarker Measurements.- Chapter 3: Preclinical Evaluations of In-Vitro Diagnostic Medical Devices.- Chapter 4: Validations of Plasma Biomarker Tests.- Chapter 5: Clinical applications of Blood Tests.
Dr. Charles Shieh-Yueh Yang finished a PhD program in physics at National Taiwan Normal University in 1999. His major focus is superconducting electronics, especially superconducting quantum interference devices (SQUIDs). From 1999 to 2004, Charles served as a postdoctoral research fellow at the Institute of Physics, Academia Sinica, Taiwan. The main topic of his postdoctoral work was bio-functionalized magnetic nanoparticles. As a faculty member at the Institute of Electro-optical Science And Technology at National Taiwan Normal University, Dr. Yang et al.
invented the so-called immunomagnetic reduction (IMR) technology and demonstrated the impact of IMR on unmet demands in the clinic. In 2008, Dr. Yang quit the faculty and started a private biotech company. Dr. Yang has been the CEO of the biotech company for more than 10 years.
Dr. Yang was the editor of the bimonthly magazine Physics of the Taiwan Association of Physics in 2006. He was the secretary of the 2006 Taiwan International Conference on Superconductivity and the 8th Workshop on Low-temperature Physics. Dr. Yang has been the principal investigator of research/technology development projects supported by the Ministry of Science and Technology, the Ministry of Economics, and the Ministry of Health and Welfare, Taiwan, since 2002. Dr. Yang has published more than 200 papers in SCI journals and has issued more than 30 patents in the U.S., Taiwan, Europe, Japan and China.
Marwan Noel Sabbagh, MD, board certified neurologist and geriatric neurologist, has dedicated his career to finding a cure for Alzheimer s and other age-related neurodegenerative diseases.
Dr. Sabbagh is a leading investigator for many prominent national Alzheimer s treatment trials. Dr. Sabbagh is on the editorial board for Journal of Alzheimer's Disease and Alzheimer s and Dementia TRCI. He is editor-in-chief of Neurology and Therapy. He has authored and co-authored over 450 medical and scientific articles on Alzheimer s research.
Dr. Sabbagh is the author of The Alzheimer s Answer: Reduce Your Risk and Keep Your Brain Healthy, with foreword by Justice Sandra Day O Connor, and of The Alzheimer s Prevention Cookbook: 100 Recipes to Boost Brain Health. He has edited Palliative Care for Advanced Alzheimer s and Dementia: Guidelines and Standards for Evidence Based Care and Geriatric Neurology, published in 2014 and Fighting for my Life: living in the shadow of Alzheimer s disease in 2019 and Strong Heart, Sharp Mind published in 2022.
Dr. Sabbagh earned his undergraduate degree from the University of California, Berkeley and his medical degree from the University of Arizona in Tucson. He received his residency training in neurology at Baylor College of Medicine, Houston, Texas, and completed his fellowship in geriatric neurology and dementia at the University of California, San Diego School of Medicine, where he served on the faculty as assistant professor.
Before joining the faculty of the Barrow Neurological Institute, he was the Camille and Larry Ruvo Endowed Chair for Brain Health, the Director of the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas and the founding Principal Investigator of the NIH funded Nevada Exploratory Alzheimer s Disease Research Center. From 2000-2015, he was the director of the Banner Sun Health Research Institute in Sun City AZ. From 2015-2018, he was the Karsten Solheim Endowed Chair for Alzheimer s research at the Barrow Neurological Institute. Presently, in addition to being vice chair, he also serves as Associate Program Director for Research for the Neurology Residency and holds the Moreno Family Chair for Alzheimer's Research.
