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Biogen, Eisai Stop Phase 3 Trials of Aducanumab in Alzheimer’s Disease

Biogen, Eisai Stop Phase 3 Trials of Aducanumab in Alzheimer’s Disease
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March 22, 2019
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CHICAGO, March 22, 2019 — On behalf of the millions of people living with Alzheimer’s disease and their families that we serve and represent, the Alzheimer’s Association is disappointed to hear the report from Biogen and Eisai that an analysis conducted by an independent data monitoring committee indicated two Phase 3 trials of aducanumab were unlikely to be successful. As a result, the companies have discontinued Phase 3 clinical trials of aducanumab in people with mild cognitive impairment (MCI) and mild Alzheimer’s disease.
It is important to note that much of the knowledge we have gained about potential new treatments, and how to properly conduct clinical trials in people with and at risk for Alzheimer’s disease, has been from clinical trials that have not met their endpoints. Learnings from these trials will eventually lead to therapies that successfully slow, stop or prevent this devastating disease in the future. It is important that the full trial data be shared with the field; we look forward to it being reported at an upcoming scientific meeting.
Alzheimer’s and other dementias are complex diseases, and their effective treatment and prevention will likely also be a complex — but achievable — task. We must advance all potential treatment targets and also explore methods for combining these approaches. No stone can be left unturned.
That said, all currently pursued treatments that are considered safe should be continued to determine their efficacy. This includes amyloid-based research for Alzheimer’s, especially in those forms of Alzheimer’s that are genetically amyloid-based, such as in the younger-onset Alzheimer's being studied in Dominantly Inherited Alzheimer’s Network Trial Unit (DIAN TU) and the Alzheimer’s Prevention Initiative (API).
When there has been urgent and high level commitment by governments and societies to funding and conducting research into the major killers — heart disease, cancer, HIV/AIDS — new methods of early detection, treatment and prevention have been the result. It is also important to acknowledge that these treatments often took many decades to discover, refine and make personal.
At the Alzheimer’s Association, we will not slow down in our fight against this terrible disease. We must continue to be relentless in our efforts to better understand the causes of Alzheimer’s disease and other dementias, and to explore additional therapeutic targets. Currently, 5.8 million Americans are living with dementia due to  Alzheimer’s disease. By 2050, this number could nearly triple to 14 million, so our efforts to change the course of Alzheimer’s disease must continue to be a priority.
The Alzheimer’s Association continues to see great progress in science, and with increased investments by the federal government in Alzheimer’s and dementia research – driven largely by Alzheimer’s Association/AIM advocacy – we are confident that progress will continue to accelerate.
The Alzheimer’s Association is leading the way in efforts to investigate new treatment strategies and targets. For example, our Part the Cloud program has invested over $30 million to advance more than 30 clinical trials. These studies are targeting a wide variety of known and potential new aspects of the disease, such as inflammation and other promising new targets for therapy. In addition, the Alzheimer’s Association is leading the U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER); the first study of a multi-component lifestyle interventions to protect cognitive function in a large-scale U.S.-based population.
Even knowing the obstacles, we have never been as optimistic as we are today. The Alzheimer’s Association is confident that we will change the trajectory of this disease.

About the Alzheimer's Association

The Alzheimer’s Association is a worldwide voluntary health organization dedicated to Alzheimer’s care, support and research. Our mission is to lead 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®. Visit or call 800.272.3900.

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