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

Florbetaben Phase 3 Study Group

Research output: Contribution to journalArticle

168 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Article number1958
Pages (from-to)964-974
Number of pages11
JournalAlzheimer's and Dementia
Volume11
Issue number8
DOIs
StatePublished - Aug 1 2015

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Amyloid Plaques
Positron-Emission Tomography
Amyloid
Alzheimer Disease
Sensitivity and Specificity
Brain
Dementia
Alzheimer disease, familial, type 3
4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene
Confidence Intervals

Keywords

  • Amyloid
  • Florbetaben
  • Histopathology
  • PET

ASJC Scopus subject areas

  • Epidemiology
  • Health Policy
  • Developmental Neuroscience
  • Clinical Neurology
  • Geriatrics and Gerontology
  • Psychiatry and Mental health
  • Cellular and Molecular Neuroscience

Cite this

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

In: Alzheimer's and Dementia, Vol. 11, No. 8, 1958, 01.08.2015, p. 964-974.

Research output: Contribution to journalArticle

Florbetaben Phase 3 Study Group. / Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease : Phase 3 study. In: Alzheimer's and Dementia. 2015 ; Vol. 11, No. 8. pp. 964-974.
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abstract = "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.",
keywords = "Amyloid, Florbetaben, Histopathology, PET",
author = "{Florbetaben Phase 3 Study Group} and Osama Sabri and Sabbagh, {Marwan N.} and John Seibyl and Henryk Barthel and Hiroyasu Akatsu and Yasuomi Ouchi and Kohei Senda and Shigeo Murayama and Kenji Ishii and Masaki Takao and Beach, {Thomas G.} and Rowe, {Christopher C.} and Leverenz, {James B.} and Bernardino Ghetti and Ironside, {James W.} and Catafau, {Ana M.} and Stephens, {Andrew W.} and Andre Mueller and Norman Koglin and Anja Hoffmann and Katrin Roth and Cornelia Reininger and Schulz-Schaeffer, {Walter J.}",
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TY - JOUR

T1 - Florbetaben PET imaging to detect amyloid beta plaques in Alzheimer's disease

T2 - Phase 3 study

AU - Florbetaben Phase 3 Study Group

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

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