Abstract
BackgroundIdentification and quantification of fibrillar amyloid in brain using positron emission tomography (PET) imaging and Amyvid™ ([18 F] Amyvid, [18 F] florbetapir, 18 F-AV-45) was recently approved by the US Food and Drug Administration as a clinical tool to estimate brain amyloid burden in patients being evaluated for cognitive impairment or dementia. Imaging with [18 F] florbetapir offers in vivo confirmation of the presence of cerebral amyloidosis and may increase the accuracy of the diagnosis and likely cause of cognitive impairment (CI) or dementia. Most importantly, amyloid imaging may improve certainty of etiology in situations where the differential diagnosis cannot be resolved on the basis of standard clinical and laboratory criteria.ResultsA consecutive case series of 30 patients (age 50-89; 16 M/14 F) were clinically evaluated at a cognitive evaluation center of urban dementia center and referred for [18 F] florbetapir PET imaging as part of a comprehensive dementia workup. Evaluation included neurological examination and neuropsychological assessment by dementia experts. [18 F] florbetapir PET scans were read by trained nuclear medicine physicians using the qualitative binary approach. Scans were rated as either positive or negative for the presence of cerebral amyloidosis. In addition to a comprehensive dementia evaluation, post [18 F] florbetapir PET imaging results caused diagnoses to be changed in 10 patients and clarified in 9 patients. Four patients presenting with SCI were negative for amyloidosis. These results show that [18 F] florbetapir PET imaging added diagnostic clarification and discrimination in over half of the patients evaluated.ConclusionsAmyloid imaging provided novel and essential data that: (1) caused diagnosis to be revised; and/or (2) prevented the initiation of incorrect or suboptimal treatment; and/or (3) avoided inappropriate referral to an anti-amyloid clinical trial.
Highlights
Diagnosis and treatment of Alzheimer’s disease (AD) has been hindered by the lack of affirmative, non-invasive in vivo measures to identify the hallmark neuropathology of the disease
Binary reading of retention of AmyvidTM has been approved recently by the US Food and Drug Administration (FDA) as a clinical tool for physicians to estimate cerebral fibrillar amyloid burden in patients being evaluated for cognitive impairment or dementia
This is the first consecutive case series report demonstrating the value of using [18 F] florbetapir positron emission tomography (PET) imaging for affirmative diagnostic confirmation and/or discrimination in a clinical sample of patients seen for evaluation at an urban, dementia center
Summary
Diagnosis and treatment of Alzheimer’s disease (AD) has been hindered by the lack of affirmative, non-invasive in vivo measures to identify the hallmark neuropathology of the disease. Binary reading of retention of AmyvidTM ( known as [18 F] florbetapir; 18 F-AV-45; [18 F] Amyvid) has been approved recently by the US Food and Drug Administration (FDA) as a clinical tool for physicians to estimate cerebral fibrillar amyloid burden in patients being evaluated for cognitive impairment or dementia. Identification and quantification of fibrillar amyloid in brain using positron emission tomography (PET) imaging and AmyvidTM ([18 F] Amyvid, [18 F] florbetapir, 18 F-AV-45) was recently approved by the US Food and Drug Administration as a clinical tool to estimate brain amyloid burden in patients being evaluated for cognitive impairment or dementia. Imaging with [18 F] florbetapir offers in vivo confirmation of the presence of cerebral amyloidosis and may increase the accuracy of the diagnosis and likely cause of cognitive impairment (CI) or dementia. Amyloid imaging may improve certainty of etiology in situations where the differential diagnosis cannot be resolved on the basis of standard clinical and laboratory criteria
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