Editor's note: This article has been updated to more accurately reflect aducanumab's position in the FDA approval pipeline.
Medical science can do astonishing things.
Eleven months after the first COVID-19 case was diagnosed in the United States, two of the companies developing vaccines to prevent the virus are applying to the FDA for emergency authorization of their drugs. Calling the initiative to discover a cure “Operation Warp Speed” may actually be an understatement.
What we’re witnessing is historic. The money, resources, technology, talent and coordination committed to developing vaccines has been staggering—and the result will go down as one of the most extraordinary feats in the annals of medicine. The task is enormously complex, as is the virus itself, but the pharmaceutical companies have figured out how to compress that complexity and distill a breakthrough that would have otherwise taken years.
Just a few weeks earlier, a different kind of pharmaceutical story was making headlines: the FDA Advisory Committee denial of approval of aducanumab, Biogen’s drug developed as a treatment for cognitive decline. For the millions of families and advocates hoping for an Alzheimer’s-disease breakthrough, the news was devastating.
Biogen had worked for 10 years on the project, and its application to the FDA was the first new Alzheimer’s drug in two decades. It’s been a long time in the wilderness for those of us hoping that drug research will yield a cure for this mystifying and catastrophic illness.
The desperation for an effective Alzheimer’s therapy is profound: “While the trial data has led to some uncertainty among the scientific community, this must be weighed against the certainty of what this disease will do to millions of Americans absent a treatment,” the Alzheimer’s Association wrote in a letter to the panel. “The potential to delay decline would be denied to millions, and that time lost for those spouses, partners, moms, dads, grandmothers, grandfathers, aunts, uncles, friends and neighbors cannot be recovered. In the balance of these considerations, we urge approval.”
An Operation Warp Speed for Alzheimer’s?
Coming so close to the remarkable COVID drug announcements, it begs the question: What if the same urgency and effort were marshaled for an Alzheimer’s cure? While dementia and the COVID-19 virus are vastly different illnesses, is it possible to build on the existing research so that, given a similarly-scaled operation, a discovery could emerge? It’s tempting to consider.
I believe that someday a drug will be discovered, or, more probably, a range of drugs, as the neurological culprits of this complicated disease are unlikely to be identified with a sweeping marker.
Even aducanumab—which works by binding to clumps of a protein called amyloid-beta, a plaque that has been a long-time target of Alzheimer’s research—has been specifically targeted for the two million Americans estimated to have mild Alzheimer’s-related cognitive decline. To put it in context, there are currently 5.6 million Americans with Alzheimer's, a number that is projected to nearly triple by 2050 as the population aged 65 and older soars.
People shouldn’t have to wait
It’s not imperative that people wait, worry and suffer. While the FDA weighs approval of aducanumab, other companies don't have to wait to develop their own advancements in the treatment of Alzheimer’s. Early intervention has been shown to reduce the risk of Alzheimer’s by as much as 40%.
Treatment shouldn’t only have to come in a bottle. Technology is transforming assessments for cognitive health, measuring cognitive strength and the presence of symptoms of decline. Digital data creates reliable and sophisticated information that can be shared with a doctor, enabling a more precise diagnosis and—most importantly—therapy.
Changing habits now can change long-term cognitive health
Managing brain health is no different than taking care of any other major organ. Awareness, testing and lifestyle choices can combat and reduce the risk of illness.
The groundbreaking 2014 FINGER protocol (The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) showed cognitive gains resulting from behavior modifications such as nutrition, exercise, cognitive training, social engagement and management of metabolic and vascular risk factors.
Lifestyle interventions adopted by the study’s 1200 participants resulted in a 25% overall cognitive improvement, 83% improvement in executive function and 150% improvement in processing speed.
While the behavior-modification approach was once dismissed as “soft science,” its clinical results have gotten the attention of Alzheimer’s researchers and organizations like the World Health Organization, which has embraced the potential of lifestyle intervention and established guidelines for action.
The FINGER breakthrough has launched a consortium of countries that have initiated “World Wide Fingers” to share information and research that builds on the initial study. In the United States, the Alzheimer’s Association is behind the initiative, partnering with Wake Forest University Medical Center on “a lifestyle intervention trial to support brain health and prevent cognitive decline.”
Solving the Alzheimer’s riddle
Let’s go back to the Operation Warp Speed proposition. What if that degree of urgency were dedicated to a hybrid effort for an Alzheimer’s cure—where the promise of the new assessment-and-therapy advances was furthered, and combined with continued research of drugs like aducanumab that attack Alzheimer’s core biology?
The COVID-19 pandemic has demonstrated what medical science is capable of in response to a public health crisis. There is no long-term health crisis more pervasive than Alzheimer’s disease. Assessment and therapy are already providing an answer. With the right effort, we can do even more.
Jordan Glenn, Ph.D., is the senior vice president of clinical development at Neurotrack, a company that develops digital solutions for cognitive health.