Results of a phase 3 trial of Alzheimer’s drug solanezumab are to be presented today (22 July) at the Alzheimer’s Association International Conference 2015.
The trial, which followed 1,322 people with mild Alzheimer’s disease, showed that the drug was able to slow the decline in memory and thinking skills over time, and suggest that the treatment may be able to slow the underlying disease process.
The anti-amyloid treatment solanezumab completed two phase III trials in 2012 (Expedition and Expedition 2), failing to reach its pre-defined endpoints in patients with mild to moderate Alzheimer’s disease. Detailed analysis of the trial results showed that those with mild Alzheimer’s did show some improvements in memory, thinking and function and the drug is currently entering another phase III trial (Expedition 3), only in people in the mild stages of the disease.
The researchers then carried out an extension study of the initial Expedition and Expedition 2 trials. In this extension, all patients with mild Alzheimer’s were moved onto solanezumab, which included those originally being given the placebo. The researchers observed the treatment response over a two-year period. The results show that people who had been treated with the drug initially as part of the trial continued to have slower decline than those moved over to the drug from placebo at the start of the extension, with thinking and memory problems reduced by around a third. This treatment effect of solanezumab was maintained over the three and a half year extension study, suggesting the drug could be having a disease-modifying effect.
Dr Eric Karran Director of Research at Alzheimer’s Research UK, the UK’s leading dementia research charity, said:
“While everyone was disappointed when solanezumab failed to meet its primary outcome measures in two phase III trials, there was evidence that the treatment was slowing down the disease process in people with mild Alzheimer’s.
“The results of the extension study show that those who were treated with solanezumab in the phase III study, and then continued on the drug, saw a sustained improvement over patients initially treated with the placebo and then moved over to the drug later. The results provide encouraging evidence that solanezumab could indeed be acting on the disease processes that drive Alzheimer’s. Although this effect represents a small improvement for people experiencing mild symptoms, it will be important for longer trials to explore whether this treatment could produce greater benefits in the long-term.
“While this could be evidence of the first disease-modifying treatment for Alzheimer’s, the ultimate test will be whether these promising effects repeat again in the third, more targeted, phase III trial in people with mild Alzheimer’s due to finish late next year. We await the results of that trial with great interest.”
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