Premium
Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study
Author(s) -
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,
SchulzSchaeffer Walter J.
Publication year - 2015
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2015.02.004
Subject(s) - histopathology , senile plaques , medicine , positron emission tomography , amyloid (mycology) , pathology , alzheimer's disease , pet imaging , nuclear medicine , disease
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 18 F‐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 .