Exploring Statistical Approaches to Demonstrate Disease Modifying Effect in Alzheimer’s Disease Trials
*Richard Y Zhang, Pfizer Inc Keywords: Alzheimer Disease, Randomized Start Design The design and analyses of Alzheimer Disease (AD) studies are often complicated by factors such as the progressive and degenerative nature of the disease and the multiple dimensions of the symptoms. In the past five drugs have been developed and approved by FDA utilizing the traditional single time point analysis and parallel design. Since such design and analysis could only demonstrate certain symptomatic effects from the treatments, newer compounds are being developed and intended to demonstrate an effect altering the course of the underlying dementia process. In this presentation, we will review the study design and statistical methods utilized from the past trials to the newer trials; discuss various disease modification strategies and viewpoints; and finally focus on Randomized Start Design and present approaches on the trial implementation and analysis.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC