Eli Lily Changes Goal of EXPEDITION3 (Alzheimer's Trial)
Eli Lilly has altered the primary objective of the scientific study of closely analyzing Alzheimer’s drug trial called Expedition 3, which was launched in July, 2013 as one of the biggest trial and was considered as a big bet on Alzheimer’s at that time.
Expedition 3 is a Phase III, placebo-controlled, double-blind, parallel-group, bayesian adaptive randomized design and dose regimen-finding study with the objectives to evaluate safety, tolerability and efficacy of Solanezumab (humanized monoclonal antibody) in subjects with early Alzheimer’s disease.
Lilly quoted that the Expedition 3 clinical trial for the drug Solanezumab in people with mild Alzheimer will now focus on the cognition as the clinical endpoint for the trial. The previous objective of this study was to focus on both cognition and function as the clinical endpoint for the drug trial but company has revived the strategy.
The reason for the change was that cognitive decline signs such as forgetfulness and memory lapses; symptoms often associated with dementia, develop relatively earlier than the symptoms of functional impairment where patients are unable to do the daily-life tasks such as dressing, cooking, appear later; quoted by the company.
The fact that this study is third attempt of the company to prove that solanezumab can change the course of Alzheimer’s disease. This therapy is primarily an antibody therapy and is designed to decline the progression of the disease that worsens in the course of years.
Lilly says that change in the primary goals of the study will not have any effect on how the study is conducted or give researcher’s any hint of which patients are getting the solanezumab and which are not. The major difference, as stated by Lilly, lies in the interpretation and analysis of the result and not in the procedure of conducting the study.
Alzheimer’s disease is a progressive kind of dementia that causes cognitive decline as well as functional impairment in the people suffering from it. This trial is primarily focused to seek approval for the drug designed by the corp.
Figure credit: Expedition 3 study logo, Boston University, USA
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