Critical review of the Appropriate Use Criteria for amyloid imaging: Effect on diagnosis and patient care

Apostolova, Liana G.; Haider, Janelle M.; Goukasian, Naira; Rabinovici, Gil D.; Chételat, Gaël; Ringman, John M.; Kremen, Sarah; Grill, Joshua D.; Restrepo, Lucas; Mendez, Mario F.; Silverman, Daniel

doi:10.1016/j.dadm.2016.12.001

Cited by 33 publications

(45 citation statements)

References 25 publications

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“…Although the impact of amyloid imaging on management plans was high in that study regardless of whether AUC-like or non-AUClike subjects were considered (88% vs. 86%), a change in diagnosis via amyloid imaging was observed significantly more often in AUC-like than in non-AUC-like subjects (62% vs. 45%). In contrast, Apostolova et al (16) found that changes in diagnosis via amyloid imaging occurred less often in (AUC-consistent) earlyonset cases than in late-onset cases, and treatment changes occurred more often in the early-onset group. Nevertheless, the current AUCs seem to provide a reasonable framework for current clinical use of amyloid imaging.…”

Section: Appropriate Use Criteria (Aucs) For Amyloid Imagingmentioning

confidence: 93%

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: Appropriate Use Criteria (Aucs) For Amyloid Imagingmentioning

confidence: 93%

Clinical Use and Utility of Amyloid Imaging

Barthel

Sabri

2017

J Nucl Med

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“…Another study also did not find significant differences in change in management between the AUC and the non-AUC groups [14] (Table 1). …”

Section: Resultsmentioning

confidence: 99%

“…One study reported significantly higher rate of diagnostic change in the AUC group compared to the non-AUC group (62 vs. 45%, p = 0.01) [27]. Similarly, another study reported higher rate of diagnostic change in the AUC group compared to the non-AUC group (53 vs. 23%), but this difference was not statistically significant [14]. In cases where the amyloid-PET scans were positive, the rate of change in diagnosis ranged from 11 to 52% [7, 19, 22, 26].…”

Section: Resultsmentioning

confidence: 99%

“…18 F radiotracers ( 18 F-florbetapir, 18 F-florbetaben, 18 F-flutemetamol, and 18 F-NAV4694) were used in 13 out of 16 studies (Table 1), and the remaining 3 studies used 11 C-PiB as the study ligand (Table 2). Amyloid scan results were interpreted visually in all studies; 2 studies used both visual and quantitative interpretation methods with the mean standard uptake value ratios of 1.17 [14] and 1.50 [20] as the quantitative cutoff for amyloid positivity (Table 3). …”

Section: Resultsmentioning

confidence: 99%

“…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%

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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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Association of Amyloid Positron Emission Tomography With Changes in Diagnosis and Patient Treatment in an Unselected Memory Clinic Cohort

et al. 2018

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IMPORTANCE Previous studies have evaluated the diagnostic effect of amyloid positron emission tomography (PET) in selected research cohorts. However, these research populations do not reflect daily practice, thus hampering clinical implementation of amyloid imaging. OBJECTIVE To evaluate the association of amyloid PET with changes in diagnosis, diagnostic confidence, treatment, and patients' experiences in an unselected memory clinic cohort. DESIGN, SETTING, AND PARTICIPANTS Amyloid PET using fluoride-18 florbetaben was offered to 866 patients who visited the tertiary memory clinic at the VU University Medical Center between January 2015 and December 2016 as part of their routine diagnostic dementia workup. Of these patients, 476 (55%) were included, 32 (4%) were excluded, and 358 (41%) did not participate. To enrich this sample, 31 patients with mild cognitive impairment from the University Medical Center Utrecht memory clinic were included. For each patient, neurologists determined a preamyloid and postamyloid PET diagnosis that existed of both a clinical syndrome (dementia, mild cognitive impairment, or subjective cognitive decline) and a suspected etiology (Alzheimer disease [AD] or non-AD), with a confidence level ranging from 0% to 100%. In addition, the neurologist determined patient treatment in terms of ancillary investigations, medication, and care. Each patient received a clinical follow-up 1 year after being scanned. MAIN OUTCOMES AND MEASURES Primary outcome measures were post-PET changes in diagnosis, diagnostic confidence, and patient treatment. RESULTS Of the 507 patients (mean [SD] age, 65 (8) years; 201 women [39%]; mean [SD] Mini-Mental State Examination score, 25 [4]), 164 (32%) had AD dementia, 70 (14%) non-AD dementia, 114 (23%) mild cognitive impairment, and 159 (31%) subjective cognitive decline. Amyloid PET results were positive for 242 patients (48%). The suspected etiology changed for 125 patients (25%) after undergoing amyloid PET, more often due to a negative (82 of 265 [31%]) than a positive (43 of 242 [18%]) PET result (P < .01). Post-PET changes in suspected etiology occurred more frequently in patients older (>65 years) than younger (<65 years) than the typical age at onset of 65 years (74 of 257 [29%] vs 51 of 250 [20%]; P < .05). Mean diagnostic confidence (SD) increased from 80 (13) to 89 (13%) (P < .001). In 123 patients (24%), there was a change in patient treatment post-PET, mostly related to additional investigations and therapy. CONCLUSIONS AND RELEVANCE This prospective diagnostic study provides a bridge between validating amyloid PET in a research setting and implementing this diagnostic tool in daily clinical practice. Both amyloid-positive and amyloid-negative results had substantial associations with changes in diagnosis and treatment, both in patients with and without dementia.

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Critical review of the Appropriate Use Criteria for amyloid imaging: Effect on diagnosis and patient care

Cited by 33 publications

References 25 publications

Clinical Use and Utility of Amyloid Imaging

Clinical Use and Utility of Amyloid Imaging

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

Association of Amyloid Positron Emission Tomography With Changes in Diagnosis and Patient Treatment in an Unselected Memory Clinic Cohort

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