Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease: Phase 3 study

• Published in: Alzheimer's & dementia Vol. 11; no. 8; pp. 964 - 974
• Main Authors: 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, Schulz-Schaeffer, Walter J
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2015
• Subjects: Aged; Aged, 80 and over; Alzheimer Disease - diagnostic imaging; Alzheimer Disease - metabolism; Alzheimer Disease - pathology; Amyloid; Amyloid beta-Peptides - metabolism; Analysis of Variance; Aniline Compounds - pharmacokinetics; Brain - diagnostic imaging; Brain - metabolism; Brain - pathology; Cohort Studies; Diagnosis; Female; Florbetaben; Histopathology; Humans; Image Processing, Computer-Assisted; Magnetic Resonance Imaging; Male; Middle Aged; Neurology; PET; Plaque, Amyloid - pathology; Positron-Emission Tomography; Psychiatric Status Rating Scales; Radiography; ROC Curve; Stilbenes - pharmacokinetics; Florbetaben; Amyloid; Histopathology; PET
• ISSN: 1552-5260; 1552-5279
• DOI: 10.1016/j.jalz.2015.02.004

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 the18 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.