LY450139 is being tested to see if it can slow the progression associated with Alzheimer’s disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. The Identity trial is a randomized, double-blind, placebo-controlled trial that will be conducted in the US and 21 additional countries.
As part of Identity, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer’s disease can continue treatment during their participation in Identity. Because the IDENTITY study also incorporates a ‘randomized delayed start’ design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.
Eric Siemers, medical director, Alzheimer’s disease research for Eli Lilly and Company, said: “Currently available medications treat the symptoms of Alzheimer’s disease but have not been shown to change its underlying progression, creating an urgent unmet medical need. Today, we are proud to announce the start of the Identity clinical trial and hold hope that LY450139 will represent an advance in the attempt to slow the progression of this fatal disease.”