Last week brought a disappointing blow to the development of new treatment options for Alzheimer’s disease when Medivation and Pfizer’s Dimebon (latrepirdine) failed the Phase III CONNECTION trial. Results from the CONNECTION study showed that Dimebon didn’t meet its primary and secondary efficacy endpoints and failed to differentiate from placebo, sending Medivation’s stocks crashing by more than 65%. There was a lot of positive anticipation before the results were released; the Phase II trial had shown that a three-times-daily 20mg dose of Dimebon preserved function in patients at or near their original levels on entering the trial across all key aspects of Alzheimer's disease; specifically memory and thinking, behaviour, activities of daily living and overall function. (Medivation press release)
Dr Mark Smith, a consultant to Medivation and professor of pathology at Case Western Reserve University, said he expected the CONNECTION trial results would not be as good as the Russian trial but even replicating 50% of the original results would be meaningful to patients. (Financial Times)
In the UK alone there are nearly 685,000 people living with some form of dementia. This is expected to rise to 940,000 by 2021, and 1.7 million by 2051, according to the Alzheimer’s Society.
With an ageing population, the prevalence of diseases like Alzheimer’s can only rise and while current therapies can alleviate symptoms there are no available options to stop its progression.
The next treatment expected to announce Phase III results is Johnson&Johnson’s bapineuzumab, a humanised monoclonal antibody targeting β-amyloid, followed closely by Lilly’s solanezumab which is currently in Phase III trials. Both of these agents work by clearing existing β-amyloid deposits from the brain or by hindering their formation. The dominant view is that other processes considered hallmarks of Alzheimer’s occur downstream from β-amyloid plaque formation.
There is a lot of scepticism surrounding Alzheimer’s treatments, with few patients continuing treatment long enough to see any real benefits. Quoted in the Financial Times, Dr Gary Kennedy, director of the division of geriatric psychology at Montefiore Medical Center in New York, said “We’re not close enough to the cause of this illness to get the silver bullet. People have to be really cautious about this.”
Despite the lack of definite causality, there are hopes that we will one day have a therapy to treat the underlying disease, not just the symptoms of Alzheimer’s. Meanwhile, symptomatic therapies, such as Aricept, Namenda and Exelon, remain important and are likely to remain the mainstay of treatment.
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