TY - JOUR
T1 - Outcomes assessment in clinical trials of alzheimer’s disease and its precursors
T2 - Readying for short-term and long-term clinical trial needs
AU - Posner, Holly
AU - Curiel, Rosie
AU - Edgar, Chris
AU - Hendrix, Suzanne
AU - Liu, Enchi
AU - Loewenstein, David A.
AU - Morrison, Glenn
AU - Shinobu, Leslie
AU - Wesnes, Keith
N1 - Publisher Copyright:
© 2017, Matrix Medical Communications. All rights reserved.
PY - 2017
Y1 - 2017
N2 - An evolving paradigm shift in the diagnostic conceptualization of Alzheimer’s disease is reflected in its recently updated diagnostic criteria from the National Institute on Aging-Alzheimer’s Association and the International Working Group. Additionally, it is reflected in the increased focus in this field on conducting prevention trials in addition to improving cognition and function in people with dementia. These developments are making key contributions towards defining new regulatory thinking around Alzheimer’s disease treatment earlier in the disease continuum. As a result, the field as a whole is now concentrated on exploring the nextgeneration of cognitive and functional outcome measures that will support clinical trials focused on treating the slow slide into cognitive and functional impairment. With this backdrop, the International Society for CNS Clinical Trials and Methodology convened semi-annual working group meetings which began in spring of 2012 to address methodological issues in this area. This report presents the most critical issues around primary outcome assessments in Alzheimer’s disease clinical trials, and summarizes the presentations, discussions, and recommendations of those meetings, within the context of the evolving landscape of Alzheimer’s disease clinical trials.
AB - An evolving paradigm shift in the diagnostic conceptualization of Alzheimer’s disease is reflected in its recently updated diagnostic criteria from the National Institute on Aging-Alzheimer’s Association and the International Working Group. Additionally, it is reflected in the increased focus in this field on conducting prevention trials in addition to improving cognition and function in people with dementia. These developments are making key contributions towards defining new regulatory thinking around Alzheimer’s disease treatment earlier in the disease continuum. As a result, the field as a whole is now concentrated on exploring the nextgeneration of cognitive and functional outcome measures that will support clinical trials focused on treating the slow slide into cognitive and functional impairment. With this backdrop, the International Society for CNS Clinical Trials and Methodology convened semi-annual working group meetings which began in spring of 2012 to address methodological issues in this area. This report presents the most critical issues around primary outcome assessments in Alzheimer’s disease clinical trials, and summarizes the presentations, discussions, and recommendations of those meetings, within the context of the evolving landscape of Alzheimer’s disease clinical trials.
KW - Clinical trials
KW - Cognition
KW - Early Alzheimer’s disease
KW - Functional assessment
KW - MCI
KW - Mild cognitive impairment
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M3 - Article
AN - SCOPUS:85017246942
VL - 14
SP - 22
EP - 29
JO - Psychiatry
JF - Psychiatry
SN - 2158-8333
IS - 1-2
ER -