Lilly to initiate second Phase III study of Alzheimer’s drug

Identity 2 is expected to enroll 1,100 patients, and includes a treatment period of approximately 21 months. An open-label extension will be available to all participants completing the study. In Identity 2, patients will be randomized to receive either 140mg of LY450139 or placebo. Patients who are taking currently available symptomatic treatments for Alzheimer’s disease can continue treatment during their participation in Identity 2.

The study also incorporates a ‘randomized delayed start’ design, which means that even those subjects initially assigned to the placebo arm will be started on LY450139 sometime before the end of the 21-month study period. Also, because investigators have the flexibility to lower and then increase the dose based on patient tolerability, Identity 2 is designed to provide a more real-world simulation of how LY450139 could be used in clinical practice.

The primary endpoints for Identity 2 are the same co-primary endpoints as the Identity trial: Alzheimer’s disease assessment scale-cognition (ADAS-cog), which measures cognitive function with an emphasis on memory, and the Alzheimer’s disease cooperative study – activities of daily living scale (ADCS-ADL), which measures the ability to independently perform daily activities such as eating, bathing, and using the telephone.

A number of optional biomarker substudies will be available to patients that will utilize brain-scanning and biochemical techniques to detect markers of Alzheimer’s disease, the company said.

Eric Siemers, medical director, Alzheimer’s disease research for Eli Lilly and Company, said: “The start of this key trial is an important landmark for Lilly, especially considering the ongoing Identity study, and the planned initiation of a Phase III study of our other investigational treatment for Alzheimer’s disease, an anti-amyloid beta monoclonal antibody, in 2009.”