Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study
Abstract Background Evaluation of brain β-amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other dementias. Methods Open-label, nonrandomized, multicenter, phase 3 study to validate the 18F-labeled β-amyloid tracer florbetaben by comparing in vivo PET imaging with post-mortem histopathology. Results Brain images and tissue from 74 deceased subjects (of 216 trial participants) were analyzed. Forty-six of 47 neuritic β-amyloid-positive cases were read as PET positive, and 24 of 27 neuritic β-amyloid plaque-negative cases were read as PET negative (sensitivity 97.9% [95% confidence interval or CI 93.8-100%], specificity 88.9% [95% CI 77.0-100%]). In a subgroup, a regional tissue-scan matched analysis was performed. In areas known to strongly accumulate β-amyloid plaques, sensitivity and specificity were 82% to 90%, and 86% to 95%, respectively. Conclusions Florbetaben PET shows high sensitivity and specificity for the detection of histopathology-confirmed neuritic β-amyloid plaques and may thus be a valuable adjunct to clinical diagnosis, particularly for the exclusion of AD. Trial registration ClinicalTrials.gov NCT01020838.
Alzheimer's and Dementia
Digital Object Identifier (DOI)
Sabri, Osama; Sabbagh, Marwan N.; Seibyl, John; Barthel, Henryk; Akatsu, Hiroyasu; Ouchi, Yasuomi; Senda, Kohei; Murayama, Shigeo; Ishii, Kenji; Takao, Masaki; Beach, Thomas G.; Rowe, Christopher C.; Leverenz, James B.; Ghetti, Bernardino; Ironside, James W.; Catafau, Ana M.; Stephens, Andrew W.; Mueller, Andre; Koglin, Norman; Hoffmann, Anja; Roth, Katrin; Reininger, Cornelia; and Schulz-Schaeffer, Walter J., "Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study" (2015). Neurology. 883.