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Activity Number: 547
Type: Contributed
Date/Time: Wednesday, August 7, 2013 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract - #309853
Title: Assessing the Cumulative Exposure Response in Alzheimer's Disease Studies
Author(s): Jianing Di*+ and Xin Zhao and Daniel Wang and Ming Lu and Michael Krams
Companies: Janssen R&D, LLC and Janssen R&D, LLC and Janssen R&D, LLC and Janssen R&D, LLC and Janssen R&D, LLC
Keywords: Cumulative exposure response ; disease progression model ; Alzheimer's disease ; MMRM ; dropout effect
Abstract:

To assess long-term cumulative benefit of a treatment, the relationship between cumulative drug exposure and outcomes could be explored to understand dose response. However, cumulative exposure corresponds to the longitudinal profile of an outcome, which is heavily confounded with natural disease progression and missing data. A model-based approach is developed to account for the confounding factors. In particular, the observed measures are adjusted by the projected disease progression at the corresponding time points before exposure response is assessed. The proposed approach introduces new insights to the interpretation of study data. In the case study used to demonstrate the method, there seem to be various degrees of efficacy trend favoring higher level of cumulative exposure in active drug, based on selected clinical and biomarker endpoints.


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