Eli Lilly’s semagacestat targeted amyloid beta plaques but patients got worse, excellent Senior Journal article says

Eli Lilly’s semagacestat targeted amyloid beta plaques but patients got worse, excellent Senior Journal article says

Alzheimer's, Dementia & Mental Health: Battle Against Alzheimer’s Disease Hits Wall as Drug Test Stopped; Maybe Plaque Not Cause seniorjournal.com

Note by Alexei Koudinov: I noticed this excellent article at www.seniorjournal.com 20 August 2010 AM Jerusalem time. Please make a visit to the original publication to appreciate this excellent report, thanks!

Excerpt: ...The efforts to prevent or successfully treat Alzheimer’s disease – the disease most feared by senior citizens - with drugs has never advanced very far, but these efforts suffered a major setback this week when Eli Lilly and Company announced it was halting development of semagacestat. This potential treatment for AD was in advanced clinical trials when it was discovered to be making patients worse instead of better. Many see this failure as a major blow to the most popular theory on the cause of the disease. The Lilly announcement said, “Studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living.”...

Lilly is instructing clinical trial investigators for all semagacestat studies to contact study participants as soon as possible and tell them to immediately stop taking the study drug. Study participants or caregivers should call their study physician to schedule their next appointment. Lilly has also informed regulatory agencies and is providing instructions to investigators outlining the process for finalizing the studies. In two pivotal Phase III trials, semagacestat was compared with placebo in more than 2,600 patients with mild-to-moderate Alzheimer's disease.

Semagacestat was designed to reduce the body's production of amyloid beta plaques, which scientists believe play an important role in causing Alzheimer's disease. Semagacestat is believed to block the activity of gamma secretase, an enzyme that is essential to the body's production of amyloid beta plaques, according to the company. It was being tested in two Phase III clinical trials called IDENTITY and IDENTITY-2.

Lilly’s interim analysis showed that, as expected, cognition and the ability to complete activities of daily living of placebo-treated patients worsened. However, by these same measures, patients treated with semagacestat worsened to a statistically significantly greater degree than those treated with placebo...

...Semagacestat was one of many drugs being tested that focus on amyloid-beta proteins, which are believed to play a critical role in Alzheimer's disease. Lilly actually has another amyloid-beta compound, solanezumab, in Phase III trials and says this testing will continue. The company says these two compounds have “different mechanisms of action”...

About the IDENTITY trials

IDENTITY (Interrupting Alzheimer's Dementia by EvaluatiNg Treatment of AmyloId PaThologY) and IDENTITY-2 are Lilly's Phase III placebo-controlled trials studying semagacestat, a gamma-secretase inhibitor being investigated as a potential treatment to slow the progression of mild to moderate Alzheimer's disease. Both Phase III trials are fully enrolled, with more than 2,600 patients from 31 countries, and include a treatment period of approximately 21 months. An open-label extension study (IDENTITY-XT) is available to all participants completing either study.

All study participants had to be at least 55 years old and meet the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease, with certain assessment scores indicating mild to moderate Alzheimer's disease. Patients with more advanced Alzheimer's disease were not included in the studies.

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