Online Program

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Wednesday, September 25
Wed, Sep 25, 8:30 AM - 9:45 AM
Statistical Issues in Chronic Disease Clinical Trials

Initiation of Symptomatic Medication in Alzheimer’s Clinical Trials: Hypothetical Versus Treatment Policy Approach (301023)

Paul S Aisen, University of Southern California 
Paul Delmar, F. Hoffmann - La Roche Ltd. 
*Michael C Donohue, University of Southern California 
Hong Liu-Seifert, Eli Lilly and Company 
Fabian Model, F. Hoffmann - La Roche Ltd. 
Michael S Rafii, University of Southern California 
Nicola Volye, F. Hoffmann - La Roche Ltd. 

Keywords: clinical trials, Alzheimer’s, intercurrent events, concurrent medication, symptomatic medication

In clinical trials in populations with Mild Cognitive Impairment, it is common for participants to initiate concurrent symptomatic medications for Alzheimer’s after randomization to the experimental therapy. One strategy for dealing with this occurrence is to censor any observations that occur after the concurrent medication is initiated. The rationale for this approach is that these observations might reflect a symptomatic benefit of the concurrent medication that would adversely bias efficacy estimates for an effective experimental therapy. We interrogate the assumptions underlying such an approach by estimating the effect of newly prescribed concurrent medications in an observational study, the Alzheimer’s Disease Neuroimaging Initiative.