Abstract
Data from clinicopathologic and biomarker studies have converged to support the view of Alzheimer’s disease (AD) as a continuum, with pathology developing decades prior to the onset of cognitive symptoms which culminate as dementia at the end stage of the disease. This concept is impacting disease nomenclature, diagnostic criteria, prognostic potential, and clinical trial design. Revisions to diagnostic criteria to incorporate biomarker results have recently been proposed in order to increase the confidence of AD as the underlying etiology of a clinical impairment and to permit a diagnosis of AD across the disease continuum, eventually perhaps in the asymptomatic period. Individuals in this preclinical stage are receiving intense focus as a targeted population for secondary prevention trials aimed at identifying disease-modifying therapies that have the best chance of preserving normal cognitive function. The goal is to bring validated biomarkers to clinical practice for the purpose of disease diagnosis, prognosis, and evaluation of therapeutic efficacy once disease-modifying treatments become available. Realization of this goal requires worldwide biomarker standardization efforts, consensus among researchers and clinicians regarding the clinical utility of assessing biomarkers in patient care settings, and eventually the endorsement and adoption of such procedures and practices into global health care systems.
Highlights
Revisions to diagnostic criteria to incorporate biomarker results have recently been proposed in order to increase the confidence of Alzheimer’s disease (AD) as the underlying etiology of a clinical impairment and to permit a diagnosis of AD across the disease continuum, eventually perhaps in the asymptomatic period
Amyloid plaques, as visualized by positron emission tomography (PET) imaging, are present in ∼60% of individuals with Mild cognitive impairment (MCI) [66], and longitudinal studies in several international cohorts have demonstrated that the combination of low cerebrospinal fluid (CSF) Aβ42 and high CSF tau and ptau is highly predictive of which MCI cases will progress to AD dementia [65, 67,68,69], as well as their rate of cognitive decline [54, 70]
The AD field is experiencing an exciting evolution, in both its appreciation of the dynamic nature of the disease and the development of therapeutic strategies aimed at modifying the underlying disease processes, and biomarkers have been at the forefront of these paradigm shifts
Summary
Alzheimer’s disease (AD) is the most common cause of dementia, accounting for up to 70% of all dementia cases, and is estimated to be the third leading cause of death, after heart disease and cancer [1]. AD currently affects 5.2 million people in the United States (US), with projected estimates reaching 13.8 million (115 million worldwide) by the year 2050 (http://www.alz.org/documents/ national/world alzheimer report 2010.pdf). In the US alone, the costs for care associated with AD in 2013 were more than $200 billion, with projected annual costs surpassing $1 trillion by the year 2050 (http://www.alz.org/alzheimers disease facts and figures.asp#cost). The 2014 US budget allocated $100 million for AD research, education, outreach, and caregiver support Certainly helpful, such funding (National Institutes of Health research funds totaling ∼$560 million annually for AD) still pales in comparison to that allocated to Advances in Geriatrics cancer, heart disease, and HIV research ($3 billion, $4 billion, and $6 billion, resp.) (http://www.alz.org/boomers/)
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