In a letter released today by UsAgainstAlzheimer's, Co-Founder and Chairman George Vradenburg said the negative clinical trial of a once-promising Alzheimer's drug, Solanezumab, which showed clinically insignificant ability to slow cognitive decline in Alzheimer's patients, should be viewed not as a failure, but as a development that "provides valuable lessons and suggests a way forward in the fight against Alzheimer's."
The letter expresses gratitude to Eli Lilly and Company for years of investment in Solanezumab, to the researchers involved with its development and testing, and to the families who sacrificed and participated in the trials. In addition, the letter outlines lessons learned in the aftermath of Lilly's announcement and essential actions that must be taken to ensure future therapies reach the millions of Alzheimer's patients and their caregivers.
In the letter, Vradenburg also stressed that the Solanezumab news underscores the need for more aggressive dosing and testing even earlier in the disease course. Solanezumab targets the beta amyloid protein that forms most of the plaque that builds up in the brains of Alzheimer's patients, and many researchers remain convinced that beta amyloid is a principal hallmark of the disease and a critical target for disease modification. Vradenburg urges the field to assess more aggressive dosing when treating this fatal disease.
"Patients and families experiencing this disease have limited and minimally effective pharmacological options," Vradenburg said. "They are demanding aggressive treatments. The devastating effects of Alzheimer's and our limited therapeutic arsenal mean that, for many with the disease, the possibility of treatment benefits far outweighs the risk of the most common side effects associated with anti-amyloid therapies. We should reflect this perception in our approach to clinical trial dosing, which has been relatively constrained in the past. Moreover, even modest disease-modifying interventions during earlier stages of disease would produce powerful cumulative effects over time that could delay or prevent symptoms of the disease."
Vradenburg emphasized that Solanezumab's results escalate the need to double down on other efforts to end Alzheimer's, incidences of which will triple by 2050. Among those efforts are the following:
- Obtaining a minimum of $2 billion in annual U.S. federal funding for Alzheimer's research, with an insistence that, in the near future, every government in the world provide funding equivalent to one percent of their Alzheimer's care costs (which, in the United States would equal $2.3 billion, according to 2016 figures).
- Calling upon President-elect Trump to exercise global leadership in this effort.
- Transforming the clinical trial system to reduce trial activation timelines, speed clinical trial recruitment and enable the more rapid testing of combination therapies to decrease trial costs and potential delays.
- Utilizing "big data" to improve the accuracy of detecting Alzheimer's disease in the early stages, thus improving researchers' abilities to target the disease at the earliest and every subsequent step of its progression.
- Achieving greater racial, income and educational diversity among clinical trial participants, realizing that, by 2030, a majority of Americans with Alzheimer's are expected to be members of current "minority" populations.
"Recent trial results must embolden us, not discourage us," he said. "Moreover, they must move us to collaborate more broadly to increase the speed of learning and the acceleration of innovative medicines to those with or at risk of Alzheimer's."