Appropriate Use Criteria for Amyloid PET: A Report of the Amyloid Imaging Task Force, the Society of Nuclear Medicine and Molecular Imaging, and the Alzheimer's Association
ABSTRACT Positron emission tomography (PET) of brain amyloid β is a technology that is becoming more available, but its clinical utility in medical practice requires careful definition. To provide guidance to dementia care practitioners, patients, and caregivers, the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging convened the Amyloid Imaging Taskforce (AIT). The AIT considered a broad range of specific clinical scenarios in which amyloid PET could potentially be used appropriately. Peer-reviewed, published literature was searched to ascertain available evidence relevant to these scenarios, and the AIT developed a consensus of expert opinion. Although empirical evidence of impact on clinical outcomes is not yet available, a set of specific appropriate use criteria (AUC) were agreed on that define the types of patients and clinical circumstances in which amyloid PET could be used. Both appropriate and inappropriate uses were considered and formulated, and are reported and discussed here. Because both dementia care and amyloid PET technology are in active development, these AUC will require periodic reassessment. Future research directions are also outlined, including diagnostic utility and patient-centered outcomes.
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ABSTRACT: In evaluating disease changes, it is critical to have measurements that are sensitive, specific, and reliable. Cognitive decline, particularly in the context of Alzheimer's disease, is an area that has attracted numerous recent studies, and the proposed biomarkers used in these investigations need to be validated. In this review, we highlight studies with important implications about the role of imaging biomarkers in cognitive decline and dementia as well as in distinguishing preclinical dementia before evidence of cognitive decline. Structural changes determined on cross-sectional and longitudinal magnetic resonance imaging provide early prediction of dementia, particularly when combined with other measures. Molecular imaging using positron emission tomography and single photon emission computed tomography tracers quantify the presence or activity of receptors, transporters, enzymes, metabolic pathways, and proteins. The newest developments in molecular imaging are described, and methods are compared. Distinguishing features of imaging biomarkers among dementias and the spectrum of preclinical Alzheimer's disease, mild cognitive impairment, and Alzheimer's disease are described. Appropriate use criteria for positron emission tomography with amyloid tracers are delineated. Although these efforts are still in the early phase of development, there is great promise for further development in structural magnetic resonance imaging and positron emission tomography technologies. Copyright © 2014 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.Biological Psychiatry 09/2014; 77(8). DOI:10.1016/j.biopsych.2014.08.024 · 9.47 Impact Factor
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ABSTRACT: Prevention trials for neurodegenerative diseases use genetic or other risk marker tests to select participants but there is concern that this could involve coercive disclosure of unwanted information. This has led some trials to use blinded enrollment (participants are tested but not told of their risk marker status). We examined the ethics of blinded vs transparent enrollment using well-established criteria for assessing the ethics of clinical research. Normative analysis applying 4 key ethical criteria-favorable risk-benefit ratio, informed consent, fair subject selection, and scientific validity-to blinded vs transparent enrollment, using current evidence and state of Alzheimer disease (AD) and other prevention trials. Current evidence on the psychosocial impact of risk marker disclosure and considerations of scientific benefit do not support an obligation to use blinded enrollment in prevention trials. Nor does transparent enrollment coerce or involve undue influence of potential participants. Transparent enrollment does not unfairly exploit vulnerable participants or limit generalizability of scientific findings of prevention trials. However, if the preferences of a community of potential participants would affect the rigor or feasibility of a prevention trial using transparent enrollment, then investigators are required by considerations of scientific validity to use blinded enrollment. Considerations of risks and benefits, informed consent, and fair subject selection do not require the use of blinded enrollment for AD prevention trials. Blinded enrollment in AD prevention trials may sometimes be necessary because of the need for scientific validity, not because it prevents coercion or undue influence. © 2015 American Academy of Neurology.Neurology 03/2015; 84(14). DOI:10.1212/WNL.0000000000001451 · 8.30 Impact Factor
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ABSTRACT: Novel diagnostic methods, such as cerebrospinal fluid-based neurochemical dementia diagnostics (CSF-NDD) and [18F] amyloid positron emission tomography (PET) are meanwhile recommended for specific indications by international guidelines for the improved early and differential diagnostics of multigenic (sporadic) Alzheimer's dementia (AD). In the case of CSF-NDD the German neuropsychiatric guidelines have already been validated on the S3 level of evidence (http://www.DGPPN.de) and the additional consideration of [18F] amyloid-PET in the current update of the guidelines is to be expected. By means of CSF-NDD and/or [18F] amyloid-PET a predictive diagnosis of incipient (preclinical) AD is also possible for patients at high risk for AD who are in prodromal stages, such as mild cognitive impairment (MCI). As accompanying (secondary) preventive therapy of AD cannot be offered a predictive molecular dementia diagnostics is not recommended by the German neuropsychiatric dementia guidelines (http://www.DGPPN.de). However, novel diagnostic approaches, which offer molecular positive diagnostics of AD have already gained high relevance in therapy research as they allow promising preventive treatment avenues to be validated directly in the clinical trial. Moreover, future blood-based dementia diagnostics by means of multiplex assays is becoming increasingly more feasible; however, so far corresponding proteomic or epigenetic assays could not be consistently validated in independent studies.Der Nervenarzt 03/2015; DOI:10.1007/s00115-014-4177-5 · 0.86 Impact Factor