Alzheimer's Association statement on solanezumab Phase 3 results
The Alzheimer's Association, the leading advocate for the more than 5 million people with Alzheimer's in the U.S., their caregivers and family members, closely observes the trials of experimental Alzheimer's and dementia therapies. While we have high hopes for every Alzheimer's and dementia therapy trial, history shows that progress is incremental and we will have setbacks along the way. These setbacks also provide critical information to the research community for application in future studies.
Eli Lilly and Company announced today that two Phase 3 studies of an experimental drug therapy called solanezumab in mild to moderate Alzheimer's disease did not meet their primary endpoints.
However, there is new and encouraging information here. According to the company, in a secondary pooled analysis of both studies, the drug at the tested dose showed a statistically significant slowing of cognitive decline in people with mild to moderate Alzheimer's disease; the results were driven by people with mild Alzheimer's. If this finding can be duplicated, it suggests that an Alzheimer's therapy targeting beta amyloid can have a beneficial effect on cognitive abilities in people with mild to moderate Alzheimer's. That would be a major step forward in the fight against Alzheimer's disease.
Another hopeful sign is that, according to the company, an open label extension study of this drug will continue. This means that people who were in the Phase 3 trials will have an opportunity to continue taking the drug. This will give us further insight into the effects of this drug over a longer period of time, and also into the value of amyloid-based therapies for people with Alzheimer's.
The company has only reported "topline" results at this time. More details will be available at the American Neurological Association annual meeting in Boston in early October. The company also says that "next steps for solanezumab have not yet been decided and will be determined after discussions with regulators." The Alzheimer's Association looks forward to seeing the full data from these studies, and also hearing about the company's discussions with the FDA about next steps for this drug.
Individuals with Alzheimer's disease and their families desperately need better treatments and new prevention strategies, and they need hope. We must not stop now. The Alzheimer's Association remains unwaveringly committed to finding better therapies and prevention strategies for Alzheimer's disease and related disorders, as well as providing support and education for people and families facing Alzheimer's disease today.
Alzheimer's disease cannot wait. By midcentury, care for people with Alzheimer's will cost the U.S. more than $1 trillion every year. This will be an enormous and unsustainable strain on the healthcare system, families, and federal and state budgets. Better treatments and preventions are absolutely necessary to reduce the financial and personal toll the disease takes on individuals, families and the healthcare system.
The U.S. National Plan to Address Alzheimer's was unveiled in May, and this plan must be speedily and effectively implemented. An additional $100 million is needed now for Alzheimer's research, education, and community support.
In addition to increased research funding, in order to develop better treatments and preventions for Alzheimer's disease, we need more volunteers for clinical trials and other research studies. Alzheimer's Association TrialMatch is a free, easy-to-use tool that matches people with Alzheimer's, friends, family, healthy volunteers, and doctors with Alzheimer's and dementia clinical studies for which they are eligible. For more information or to use TrialMatch, go to www.alz.org or call 800-272-3900.
This summer, the Alzheimer's Association is hosting town hall events in local communities across the country. These events will allow you and your fellow members of the Alzheimer's community to publicly voice your opinions about the impact that a successfully implemented National Alzheimer's Plan. Visit www.alz.org/plan to participate.
The Alzheimer's Association leads the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. For more information, visit www.alz.org or call the 24/7 Helpline at 800.272.3900.