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

2015-03-28

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

Florbetaben Phase 3 Study Group

Journal Article

0000-0003-3910-2453

10.1016/j.jalz.2015.02.004

Evaluation of brain β-amyloid by positron emission tomography (PET) imaging can assist in the diagnosis of Alzheimer disease (AD) and other dementias.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.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.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.ClinicalTrials.govNCT01020838.

link

Alzheimer's & Dementia : the Journal of the Alzheimer's Association 2015; 11(8): 964-74

Alzheimer's & dementia : the journal of the Alzheimer's Association