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Lilly Announces Initiation of Second Global Phase III Trial of Investigational Alzheimer's Disease Compound
Date:10/1/2008

said Eric Siemers, M.D., medical director, Alzheimer's disease research for Eli Lilly and Company. "IDENTITY 2 is a study that we believe will give us additional insights into how LY450139 might best be given to patients in real clinical situations, information that is often not learned until a medicine is approved and prescribed in clinical practice. 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, next year. Lilly has a strong commitment to Alzheimer's disease -- we have an extensive early research program and are the only pharmaceutical company with two of its own Alzheimer's disease molecules in active late-stage development."

IDENTITY 2 - Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY

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 140 mg 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-Cog
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