TY - JOUR
T1 - Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease
T2 - Phase 3 study
AU - Sabri, Osama
AU - Sabbagh, Marwan N.
AU - Seibyl, John
AU - Barthel, Henryk
AU - Akatsu, Hiroyasu
AU - Ouchi, Yasuomi
AU - Senda, Kohei
AU - Murayama, Shigeo
AU - Ishii, Kenji
AU - Takao, Masaki
AU - Beach, Thomas G.
AU - Rowe, Christopher C.
AU - Leverenz, James B.
AU - Ghetti, Bernardino
AU - Ironside, James W.
AU - Catafau, Ana M.
AU - Stephens, Andrew W.
AU - Mueller, Andre
AU - Koglin, Norman
AU - Hoffmann, Anja
AU - Roth, Katrin
AU - Reininger, Cornelia
AU - Schulz-Schaeffer, Walter J.
PY - 2015/8/1
Y1 - 2015/8/1
N2 - 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.
AB - 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.
KW - Amyloid
KW - Florbetaben
KW - Histopathology
KW - PET
UR - http://www.scopus.com/inward/record.url?scp=84939264152&partnerID=8YFLogxK
U2 - 10.1016/j.jalz.2015.02.004
DO - 10.1016/j.jalz.2015.02.004
M3 - Article
AN - SCOPUS:84939264152
SN - 1552-5260
VL - 11
SP - 964
EP - 974
JO - Alzheimer's & Dementia: The Journal of the Alzheimer's Association
JF - Alzheimer's & Dementia: The Journal of the Alzheimer's Association
IS - 8
M1 - 1958
ER -