Designing and Analyzing Clinical Trials on DIAN
*Chengjie Xiong, Washington University Keywords: DIAN, Alzh This ongoing trial (Phase 2) recruited participants who were either known to have a disease-causing mutation (presenilin 1 (PSEN1), presenilin 2 (PSEN2) and amyloid precursor protein (APP)) or who were at risk for such a mutation (the child or sibling of a proband with a known mutation) and unaware of their genetic status from the Dominantly Inherited Alzheimer’s Network (DIAN), a multicenter international longitudinal observational study supported by the National Institutes of Health (U01-AG032438). This talk will discuss the design and analytic challenges that have emerged from the trial, including multiple drugs with different mechanisms of action and a delayed treatment arm on the biomarker phase, multiple primary efficacy endpoints, multiple regions/sites, randomization and minimization across multiple regions, power analyses, interim and final efficacy analyses. This talk will also discuss the seamless transition to cognitive endpoint phase (Phase III), i.e., the anticipated design and analytic challenges including the selection and analyses of primary cognitive endpoint for the Phase III trial across regions.
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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