Assessment of the Incremental Diagnostic Value of Florbetapir F 18 Imaging in Patients With Cognitive Impairment

Boccardi, Marina; Altomare, Daniele; Ferrari, Clarissa; Festari, Cristina; Guerra, Ugo Paolo; Paghera, Barbara; Pizzocaro, Claudio; Lussignoli, Giulia; Geroldi, Cristina; Zanetti, Orazio; Cotelli, Maria Sofia; Turla, Marinella; Borroni, Barbara; Rozzini, Luca; Mirabile, Dario; Defanti, C. A.; Gennuso, Michele; Prelle, A.; Gentile, Simona; Morandi, Alessandro; Vollaro, Stefano; Volta, Giorgio Dalla; Bianchetti, Angelo; Conti, Marta Zaffira; Cappuccio, Melania; Carbone, Pasqualina; Bellandi, Daniele; Abruzzi, Luciano; Bettoni, L; Villani, Daniele; Raimondi, Maria Clara; Lanari, Alessia; Ciccone, Alfonso; Facchi, Emanuela; Fazio, Ignazio Di; Rozzini, Renzo; Boffelli, Stefano; Manzoni, Laura; Salvi, Giovanni Pietro; Cavaliere, Sabina; Belotti, Gloria; Avanzi, Stefano; Pasqualetti, Patrizio; Muscio, Cristina; Padovani, Alessandro; Frisoni, Giovanni B.

doi:10.1001/jamaneurol.2016.3751

Cited by 87 publications

(76 citation statements)

References 44 publications

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“…Sixteen studies concerning the clinical utility of amyloid PET imaging were found in the literature (17,(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48). Supplemental Table 3 summarizes these studies.…”

Section: Clinical Utility Of Amyloid Imagingmentioning

confidence: 99%

Clinical Use and Utility of Amyloid Imaging

Barthel

Sabri

2017

J Nucl Med

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Currently, 3 amyloid PET tracers are approved and commercially available for clinical use. They allow for the accurate in vivo detection of amyloid plaques, one hallmark of Alzheimer disease. Here, we review the current knowledge on the clinical use and utility of amyloid imaging. Appropriate use criteria for the clinical application of amyloid imaging are established, and most currently available data point to their validity. Visual amyloid image analysis is highly standardized. Disclosure of amyloid imaging results is desired by many cognitively impaired subjects and seems to be safe once appropriate education is delivered to the disclosing clinicians. Regarding clinical utility, increasing evidence points to a change in diagnosis via amyloid imaging in about 30% of cases, to an increase in diagnostic confidence in about 60% of cases, to a change in patient management in about 60% of cases, and specifically to a change in medication in about 40% of cases. Also, amyloid imaging results seem to have a relevant impact on caregivers. Further, initial simulation studies point to a potential positive effect on patient outcome and to cost effectiveness of amyloid imaging. These features, however, will require confirmation in prospective clinical trials. More work is also required to determine the clinical utility of amyloid imaging specifically in subjects with mild cognitive impairment and in comparison with or in conjunction with other Alzheimer disease biomarkers. In summary, the clinical use of amyloid imaging is being studied, and the currently available data point to a relevant clinical utility of this imaging technique. Ongoing research will determine whether this accurate and noninvasive approach to amyloid plaque load detection will translate into a benefit to cognitively impaired subjects. Wi th the successful development and subsequent clinical approval of 18 F-florbetapir, 18 F-florbetaben, and 18 F-flutemetamol, the nuclear imaging community has a set of b-amyloid aggregatetargeting PET tracers in hand for clinical use. They allow the in vivo detection or exclusion of neuritic b-amyloid plaques, one histopathologic hallmark in the neocortex of patients with Alzheimer disease (AD), which previously could be diagnosed only histopathologically after death. Of note, brain b-amyloid accumulation is known to be an early event in this disease (1) and is considered by many as the initial trigger of a cascade of other pathobiochemical and pathophysiologic alterations finally leading to neurodegeneration and related cognitive decline in AD (2).The emergence of amyloid imaging technology is hoped to fill a relevant diagnostic gap in the clinic in cognitively impaired subjects and in AD in particular. Most people would like to get a diagnosis when cognitive symptoms are identified (3). Conversely, dementia diagnosis is often missed and delayed (4,5). With regard to the therapeutic implications of an AD diagnosis, it was reported that older people are willing to accept the relevant side effects of AD-modifying therap...

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Section: Clinical Utility Of Amyloid Imagingmentioning

confidence: 99%

Clinical Use and Utility of Amyloid Imaging

Barthel

Sabri

2017

J Nucl Med

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“…Five studies were conducted in the US [7, 14, 15], 2 studies in the UK [16, 17], 2 in Netherlands [18, 19], and 1 each in Italy [10], Canada [20], France [21], and Denmark [22]. Two studies were multicenter studies with one study conducted in Australia, Germany, Japan, Switzerland, and USA [23], and the other in France, Italy, and USA [24].…”

Section: Resultsmentioning

confidence: 99%

“…In cases where prescan diagnosis was AD, the rate of change in diagnosis ranged from 13 to 37% [10, 15, 18-20, 25, 26]. When prescan diagnosis was non-AD etiology, diagnostic change ranged from 14 to 62% [10, 18-20, 26].…”

Section: Resultsmentioning

confidence: 99%

“…Several 18 F amyloid ligands have been developed, including 18 F-florbetapir (Amyvid TM ), 18 F-flutemetamol (Vizamyl TM ), 3′F-PiB or GE-067, 18 F-florbetaben (Neuraceq TM ; also called BAY94–9172 or AV-1), and 18 F-NAV4694 (formerly AZD4694) [9]. At the present time, 18 F-labeled ligands 18 F-florbetapir, 18 F-flutemetamol, and 18 F-florbetaben have been approved for use in clinical settings by the US Food and Drug Administration (FDA) [10]. …”

Section: Introductionmentioning

confidence: 99%

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A Review of Diagnostic Impact of Amyloid Positron Emission Tomography Imaging in Clinical Practice

Kim

Rosenberg

2018

Dement Geriatr Cogn Disord

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Background: Molecular imaging of brain amyloid for the diagnosis of Alzheimer’s disease (AD) using positron emission tomography (PET) has been approved for use in clinical practice by the Food and Drug Administration (FDA) since 2012. However, the clinical utility and diagnostic impact of amyloid PET imaging remain controversial. We conducted a review of the recent studies investigating clinical utility of amyloid PET imaging with focus on changes in diagnosis, diagnostic confidence, and patient management. Summary: A total of 16 studies were included in the final analysis. Overall rate of changes in diagnosis after amyloid PET ranged from 9 to 68% (pooled estimate of 31%, 95% CI 23–39%). All studies reported overall increase in diagnostic confidence or diagnostic certainty after amyloid PET. Changes in patient management ranged from 37 to 87%; the most common type of change in management reported was either the initiation or discontinuation of planned AD medications. Key Messages: Amyloid PET imaging led to moderate to significant changes in diagnosis, diagnostic confidence, and subsequent patient management. It may be most useful in patients with high level of diagnostic uncertainty even after the completing the standard workup.

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“…A negative amyloid scan indicates sparse to no amyloid plaques and is inconsistent with a diagnosis of AD (5). A negative amyloid scan in a patient who has a clinical diagnosis of AD has been shown to be of great clinical value, as it suggests a misdiagnosis and often results in changes to subsequent therapeutic planning (6).…”

Section: Discussionmentioning

confidence: 99%