Alzheimer community between disappointment and hope regarding drug development at CTAD conference 2016

clinical-1Almost 50 million people worldwide now have dementia, and it is estimated that 60-70% of them are living with Alzheimer’s disease. There have been no new drugs approved for the treatment of Alzheimer’s since 2003 and the community of people with dementia and their families, researchers, clinicians and Alzheimer associations globally are eagerly looking for some good news. The International Congress on Clinical Trials for Alzheimer’s Disease (CTAD) is always a good place to get an overview of what is in the pipeline and the 9th CTAD took place last week in the city of San Diego in South California, USA.

There are a number of possible new treatments being developed for which people have high expectations. Eli Lilly and Company reported two weeks ago that the results in a second phase III trial of solanezumab were negative. Lilly used the conference to present the data of the study in more detail and this was followed by a panel discussion between experts.

Results of the phase III trial of Solanezumab announced at the 9th CTAD Congress in 2016 showed limited effect when measured against a placebo.

Data from the study showed that participants who used the medication showed a slight improvement on a number of measures compared to those that received a placebo, but the difference was not big enough to be significant. That means that the result of the study was negative and Lilly will not put solanezumab forward for approval.

The mood at the conference was of high disappointment, but at the same time not giving up for the future.

Lilly deserved credit from the audience for the sober and honest way the data was presented. The scientific community will now further debate what these results indicate for the directions to take the search  for a cure for dementia including Alzheimer’s Disease. The mood at the conference was of disappointment, but at the same time of not giving up for the future.

However, there was some more positive news as well …

Firstly, Biogen reported data on the extension of their first trial with a compound called aducanumab. This was a smaller study that was reported on in 2015 and a phase III trial has just started recruitment. In the meantime the participants in the first study were offered an extension for another 12 months and most of them stayed in the study so that results could be measured after 24 months. Although this was a small sample of volunteers, the results were promising, including for those people who originally received a placebo but had  switched to the real drug. We have to wait and see if this data is going to be confirmed in the much bigger phase III study and it will take at least another three years before we know the results.

The other results that caught my attention were from the LipiDiDiet trial – an independent study funded by the European Union investigating the nutritional intervention Souvenaid. This study compares the effect of the medical nutrition drink to a placebo in people with prodromal Alzheimer’s disease. The investigators showed results from the 2 year Randomised Control Trial (RCT) phase of this study. These add to the growing body of evidence for this intervention, demonstrating clearly favourable effects on cognition and function, as well as significantly less brain shrinkage in those taking the product. Further long-term data will become available from the optional extension phases over the course of coming years. The investigators are also developing diet and lifestyle advice for the elderly.

It is important that more research is still needed, and that as many people as possible are encouraged to support this by becoming involved in clinical trials.

I welcome the hope for these and other possible new treatments for dementia at the end of 2016, that could help improve the lives of those affected by dementia and their care partners everywhere. It is important to say that more research is still needed, and that as many people as possible are encouraged to support this by becoming involved in clinical trials.

By Marc Wortmann – Executive Director, Alzheimer’s Disease International (ADI)

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