Outcomes assessment in clinical trials of alzheimer’s disease and its precursors: Readying for short-term and long-term clinical trial needs

Holly Posner, Rosie Curiel Cid, Chris Edgar, Suzanne Hendrix, Enchi Liu, David Loewenstein, Glenn Morrison, Leslie Shinobu, Keith Wesnes

Research output: Contribution to journalArticlepeer-review

19 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)22-29
Number of pages8
JournalInnovations in Clinical Neuroscience
Volume14
Issue number1-2
StatePublished - 2017

Keywords

  • Clinical trials
  • Cognition
  • Early Alzheimer’s disease
  • Functional assessment
  • MCI
  • Mild cognitive impairment

ASJC Scopus subject areas

  • Clinical Neurology
  • Psychiatry and Mental health

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