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Lilly Presents Follow-Up Data on Semagacestat to Assist Future Alzheimer's Disease Research
Date:7/19/2011

itially treated with semagacestat remained worse than the deficits of patients initially treated with placebo. However, the course of the decline over time in the two groups did not diverge further after dosing was stopped.

Alzheimer's disease is a fatal form of dementia that causes progressive decline in memory and other aspects of cognition.(1) Researchers do not know exactly what causes Alzheimer's, but one hypothesis is that beta-amyloid protein plays an important role.(1,2)

"Although today we focused on what happened with semagacestat, the broader important point is that Lilly remains committed to Alzheimer's research and the Alzheimer's disease community," said Dr. Siemers. "We continue to move forward with the development of other molecules in our pipeline aimed at slowing the progression of Alzheimer's disease."

Study Methods

An external Data Monitoring Committee (DMC) was established prior to beginning the semagacestat IDENTITY studies so that they could monitor safety during the trials; unlike the patients and investigators, the DMC knew which patients were taking semagacestat and which patients were taking placebo. A planned analysis of the cognitive data by the DMC partway through the trial showed the increased rate of worsening, leading to the decision to discontinue dosing of semagacestat. The IDENTITY trials were then modified substantially in order to obtain more data for approximately seven months while the patients were no longer taking semagacestat. By studying the patients after stopping dosing, some of the factors that may have led to the increased cognitive decline could be more fully understood.  

Study Findings

After 76 weeks of treatment with semagacestat or placebo, patients taking placebo (501 patients) worsened by 6.19 points on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog11), which is approximately the amount of change expected for placebo-treated patie
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SOURCE Eli Lilly and Company
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