Publications & White Papers

Archive for February, 2008

An Adaptive Optimal Design for the EMAX Model and its Application in Alzheimer’s Disease

February 1st, 2008

An Adaptive Optimal Design for the EMAX Model and its Application in Alzheimer’s Disease

Sergei Leonov and Sam Miller

Abstract: A project team working on a compound to treat Alzheimer’s disease is carrying out a first-time-in-human dose-escalation study in patients. The team wished to maximize the efficiency of the study by using doses targeted at maximizing information about the dose-response relationship within certain safety constraints. We have developed a GUI-based adaptive optimal design tool to recommend doses when the response follows an Emax model, with functionality for pre-trial simulation and in-stream analysis.