Week of April 6 - April 12, 2008

Eli Lilly & Co. is beginning the decisive phase of its IDENTITY trial to gain approval for a potentially revolutionary Alzheimer's medication. The success of the medication would be a treatment revolution because it interrupts the progress of Alzheimer's. Currently, there are 5 FDA-approved medications for Alzheimer's which compensate for losses caused by Alzheimer's, without actually preventing its progression.

The IDENTITY Trial - Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY - is a randomized, double-blind, placebo-controlled trial that will be conducted in the U.S. and 21 additional countries. 1,500 patients will be studied for 21 months.

The medicine being test is Eli Lilly's LY450139, a gamma secretase inhibitor for the treatment of mild to moderate Alzheimer's disease. 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. Current Alzheimer's disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.

Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer's patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer's disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.

Eli Lilly's IDENTITY trial now enters Phase III, and will be conducted in the U.S. 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.

"Alzheimer's is a devastating disease that destroys brain cells, affecting everything from a patient's memory to their work and social life. 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. We encourage patients or their caregivers to review the enrollment criteria for IDENTITY to see if they are eligible to participate," said Eric Siemers M.D., Medical Director, Alzheimer's disease research for Eli Lilly and Company.

To more completely characterize the disease-modifying effects of LY450139, a number of optional biomarker sub-studies will be available to patients. These optional sub-studies will utilize new brain-scanning techniques to determine the amount of amyloid beta plaque in the brain, employ other, more established scanning techniques to examine brain structure and function, and evaluate a number of additional biochemical measures of Alzheimer's disease. By determining the effect of LY450139 on these objective biomarkers, a more complete understanding of the effect of LY450139 on underlying Alzheimer's disease pathology is possible.

Additional information regarding the IDENTITY trial, including global recruitment sites, may be found by visiting www.clinicaltrials.gov or www.lillytrials.com, or by calling 1-877-CTLilly (1-877-285-4559).

MORE INFORMATION

Trial Recruitement:

www.clinicaltrials.gov

www.lillytrials.com

USA: 1-877-CTLilly (1-877-285-4559)

About LY450139

LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creating a shorter, sticky protein called amyloid beta. Alzheimer's disease theory suggests that some subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. Clinical studies have examined the effect of LY450139 on amyloid beta in blood and cerebrospinal fluid. The most frequently occurring side effects experienced in earlier clinical studies with LY450139 include diarrhea, upset stomach, and fatigue. For a more complete listing of potential side effects, prospective clinical trial participants should refer to the informed consent document.

About Lilly

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com. P-LLY

This research article contains forward-looking statements about the potential of the investigational compound LY450139 and reflects Ely Lilly's current beliefs. However, as with any pharmaceutical product under development, there are substantial risks and uncertainties in the process of development and regulatory review.

BY:

Edited by Peter Berger, Alzheimer's Weekly

Reviewed for medical accuracy by
Dr. Boaz Ancselovic, MD, Geriatrician, Alzheimer's Weekly

SOURCES:

Eli Lilly and Company

COPYRIGHT:

Copyright © 2008 Alzheimer's Weekly LLC. All rights reserved.