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Slowing the rate of disease progression could preserve independentfunctioning and quality of life for Alzheimer's patients in the milder stagesof the disease, potentially delaying the onset of the severe stages of thedisease. Currently available treatments for Alzheimer's disease have nodocumented effect on amyloid beta. They provide modest improvements insymptoms but do not slow the underlying disease process.
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The IDENTITY Trial - Interrupting Alzheimer's Dementia by EvaluatiNgTreatment of AmyloId PaThologY
IDENTITY is a randomized, double-blind, placebo-controlled trial that willbe 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 willbe available to all participants completing the study. Patients who aretaking currently available symptomatic treatments for Alzheimer's disease cancontinue treatment during their participation in IDENTITY. Because theIDENTITY study also incorporates a "randomized delayed start" design, eventhose subjects initially assigned to the placebo arm of the study will bestarted on active LY450139 treatment sometime before the end of the 21-monthstudy period. Both the subjects and investigators will be blinded to theexact timing of this delayed start of study drug administration.
"Alzheimer's is a devastating disease that destroys brain cells, affectingeverything from a patient's memory to their work and social life. Currentlyavailable medications treat the symptoms of Alzheimer's disease but have notbeen shown to change its underlying progression, creating an urgent unmetmedical need. Today, we are proud to announce the start of the IDENTITYclinical trial and hold hope that LY450139 will represent an advance in theattempt to slow the progression of this fatal disease. We encourage patientsor their caregivers to review the enrollment criteria for IDENTITY to see ifthey are eligible to participate," said Eric Siemers M.D., Medical Director,Alzheimer's disease research for Eli Lilly and Company.
Alzheimer's disease is a progressive neurodegenerative condition that isthe most common cause of dementia in patients over 65 years of age. Estimatesshow that 6-8% of people over age 65 are affected by Alzheimer's disease(1),totaling approximately 5 million people in the United States alone(2). Every72 seconds, an American is developing Alzheimer's disease(3), and it is theseventh-leading cause of death in the United States(4). The direct andindirect health care costs associated with Alzheimer's disease in the U.S. areestimated to be about $150 billion(5). In 2005, the total cost worldwide wasestimated at $315.4 billion(6).
Given the aging population, without the availability of medicines thatdelay or prevent the onset of Alzheimer's disease, the number of affectedpeople is expected to at least triple by the year 2050 in developednations(7). The average duration between onset of symptoms and death due tocomplications of Alzheimer's disease is about 8-10 years(8). The burden tocaregivers and health care costs can increase dramatically in the late stagesof Alzheimer's disease, when patients cannot maintain independent function andare frequently bedr
