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Amyloid‐related imaging abnormalities in amyloid‐modifying therapeutic trials: Recommendations from the Alzheimer's Association Research Roundtable Workgroup
Author(s) -
Sperling Reisa A.,
Jack Clifford R.,
Black Sandra E.,
Frosch Matthew P.,
Greenberg Steven M.,
Hyman Bradley T.,
Scheltens Philip,
Carrillo Maria C.,
Thies William,
Bednar Martin M.,
Black Ronald S.,
Brashear H. Robert,
Grundman Michael,
Siemers Eric R.,
Feldman Howard H.,
Schindler Rachel J.
Publication year - 2011
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.2011.05.2351
Subject(s) - medicine , workgroup , hyperintensity , clinical trial , subclinical infection , pathology , disease , amyloidosis , etiology , hemosiderin , magnetic resonance imaging , radiology , computer network , computer science
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.