A Collaborative Cross-Pharma Validation of Novel Composite Outcome Measures for Pre-Dementia Alzheimer’s Disease
*Nandini Raghavan, Janssen R&D Keywords: Endpoints, Outcome Measures, Alzheimer's Disease, Cross-pharma Collaboration One of the biggest challenges in designing clinical trials for earlier, pre-dementia stages of Alzheimer’s Disease is determining the right efficacy endpoint to capture change. In this talk, we discuss the efforts of the Clinical Endpoints Working Group (CEWG) of the ADNI Private Partner Scientific Board (PPSB) to evaluate a number of recently proposed novel composite outcome measures. Several of these composite measures were developed by identifying sensitive subscales of existing measures in available datasets, especially ADNI. The Working Group identified available public and proprietary datasets that could be used for the evaluation. Simultaneously statistical, neuropsychological and clinical evaluation criteria were also determined. Statisticians and analysts in the Working Group from the various participating companies are collaboratively developing an R-package for the evaluation. A systematic evaluation of the proposed measures will be performed on available datasets in order to study their attributes and come to a common understanding of their strengths and limitations. In this presentation, we will describe the details of this novel collaboration model, the evaluation template, and also present some preliminary results from the evaluation.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC