@article{b092d6f959334714935da9ce7d6d89f5,
title = "Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: Recommendations from the Alzheimer's Association Research Roundtable Workgroup",
abstract = "Amyloid imaging related abnormalities (ARIA) have now been reported in clinical trials with multiple therapeutic avenues to lower amyloid-β burden in Alzheimer's disease (AD). In response to concerns raised by the Food and Drug Administration, the Alzheimer's Association Research Roundtable convened a working group to review the publicly available trial data, attempts at developing animal models, and the literature on the natural history and pathology of related conditions. The spectrum of ARIA includes signal hyperintensities on fluid attenuation inversion recoverysequences thought to represent {"}vasogenic edema{"} and/or sulcal effusion (ARIA-E), as well as signal hypointensities on GRE/T2 thought to represent hemosiderin deposits (ARIA-H), including microhemorrhage and superficial siderosis. The etiology of ARIA remains unclear but the prevailing data support vascular amyloid as a common pathophysiological mechanism leading to increased vascular permeability. The workgroup proposes recommendations for the detection and monitoring of ARIA in ongoing AD clinical trials, as well as directions for future research.",
keywords = "Amyloid, MRI, Microhemorrhage, Therapeutic trials, Vasogenic edema",
author = "Sperling, {Reisa A.} and Jack, {Clifford R.} and Black, {Sandra E.} and Frosch, {Matthew P.} and Greenberg, {Steven M.} and Hyman, {Bradley T.} and Philip Scheltens and Carrillo, {Maria C.} and William Thies and Bednar, {Martin M.} and Black, {Ronald S.} and Brashear, {H. Robert} and Michael Grundman and Siemers, {Eric R.} and Feldman, {Howard H.} and Schindler, {Rachel J.}",
note = "Funding Information: Disclosures: Dr. R.A.S. has served as a site investigator for Avid, Bristol-Myers Squibb, Elan, Janssen, Pfizer, and Wyeth, and as a consultant to Avid (unpaid), Bayer, Bristol-Myers Squibb, Elan, Eisai, Janssen, Pfizer, Roche, and Wyeth. Dr. C.R.J. Jr. serves as a consultant for Janssen, Lilly, GE, Johnson and Johnson, Eisai, and Elan, and is an investigator in clinical trials sponsored by Pfizer, Allon, and Baxter, Inc. Dr. S.E.B. has received contract research funds to the Cognitive Neurology and Stroke Research Units from Roche, GlaxoSmithKline, Novartis Pharmaceuticals, Myriad Pharmaceuticals, Pfizer, Sanofi-Aventis, Boehringer Ingelheim, Novo Nordisk, and AstraZeneca. In addition, she has received speaker{\textquoteright}s honoraria for CME from Janssen-Ortho, Novartis Pharmaceutical, Lundbeck, Pfizer, Eisai, and Myriad Pharmaceuticals, and honoraria for ad hoc consulting from Pfizer, Janssen-Ortho, Novartis Pharmaceuticals, Lundbeck, Myriad Pharmaceuticals, GlaxoSmithKline, Schering-Plough, Elan, Wyeth Pharmaceuticals, Bristol-Myers Squibb, and Eisai. Dr. S.M.G. serves as a consultant for Hoffman-La Roche, Janssen Alzheimer Immunotherapy, and Bristol-Myers Squibb Company, and has received honoraria from Medtronic and Pfizer. Dr. B.T.H. has consulted with several pharmaceutical and biotechnology companies: EMD Serrano, Janssen, Takeda, BMS, Neurophage, Pfizer, Quanterix, foldrx, Elan, and Link. Dr. P.S. serves as a consultant to Roche AG, Novartis AG, Genentech, Danone Research, Lundbeck, GE Healthcare, and Avid. Drs. M.M.B. and R.J.S. are employed by Pfizer. Dr. R.S.B. is a full-time employee of Pfizer and owns stock in the company. Dr. H.R.B. is employed by Johnson and Johnson. Dr. M.G. has consulted for Janssen Alzheimer Immunotherapy, Johnson and Johnson, Elan Pharmaceuticals, and Avid Radiopharmaceuticals. Dr. E.R.S. is a full-time employee and stockholder at Eli Lilly. Dr. H.H.F. is a full-time employee and holds stock with Bristol-Myers Squibb. Drs. M.C.C. and W.T. are employees of the Alzheimer{\textquoteright}s Association and report no conflicts. ",
year = "2011",
month = jul,
doi = "10.1016/j.jalz.2011.05.2351",
language = "English (US)",
volume = "7",
pages = "367--385",
journal = "Alzheimer's and Dementia",
issn = "1552-5260",
publisher = "Elsevier Inc.",
number = "4",
}