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Another major Alzheimer's drug failed in clinical trials. Is it time for a new approach?


Read Advisory Board's take: What this failure means for providers

Biogen and Japan-based Eisai last week announced a highly anticipated experimental drug designed to treat Alzheimer's disease failed to show clinical benefits, marking the latest failure in Alzheimer's treatment research that has many in the scientific community considering alternative approaches to attack the disease.

About Alzheimer's disease

Alzheimer's disease is a type of dementia traditionally defined as a clinical syndrome involving the progressive decline of cognitive abilities—particularly memory loss—that ultimately results in the loss of independence. About 5.8 million U.S. residents have Alzheimer's disease, and CDC projects that number will reach 13.9 million by 2060 as baby boomers age. There is no proven treatment.

 


Cheat sheet: What you need to know about the geriatrics market

 

Pharmaceutical companies over more than a decade have spent billions of dollars on research to find a treatment for Alzheimer's.

Research, including the trials for Biogen and Eisai, has largely focused on the beta amyloid protein, which accumulates in the brains of Alzheimer's patients years before they experience memory loss. Researchers have hypothesized that the buildup in the brain from the beta-amyloid was responsible for the cognitive decline seen in Alzheimer's patients.

The latest setback in finding a treatment for Alzheimer's disease

Biogen and Eisai's experimental drug, called aducanumab, aimed to treat Alzheimer's disease by targeting and removing the beta-amyloid that accumulates in the brains of Alzheimer's patients.  The companies enrolled in their trials patients who exhibited early signs of Alzheimer's disease to test whether aducanumab could remove the buildup and improve patients' cognitive abilities.

But an independent analysis of the trials determined the drug would likely not be successful in the trials. As such, the companies last week announced they would end two late-stage clinical trials evaluating the drug.

Biogen and Eisai's drug is the latest of an estimated 150 to 300 experimental Alzheimer's treatments that have failed to show clinical benefits, according to Axios' "Vitals." As a result, Samuel Gandy, associate director of the Mount Sinai Alzheimer's Disease Research Center, told Bloomberg, "I admit to you, we are getting pretty desperate."

That said, the failed drug trials still have helped researchers learn more about Alzheimer's and the disease, CNBC reports.

Researchers explore other ways to treat Alzheimer's

George Yancopoulos, the chief scientific officer at Regeneron, which is developing an Alzheimer's drug targeting infectious-like proteins called prions that might play a major role in the disease, said, "Any breakthrough requires deep understanding of pathways and targets." He added, "In neurodegenerative disease, we're only just beginning to get to that point to understand what the targets are for intervention."

Separately, Heather Snyder, senior director of medical and scientific operations for the Alzheimer's Association, said, researchers are "are optimistic that as [their] understanding of the science" surrounding Alzheimer's "continues to grow and go forward, [their] ability to … target the different biologies" of the disease will improve" (Baker, "Vitals," Axios, 3/25; LaVito/Lovelace, CNBC, 3/23; Langreth, Philadelphia Inquirer, 3/24; Walker/Loftus, Wall Street Journal, 3/24; Feuerstein, STAT News, 3/21; Molina, CNBC, 9/21/18).

Advisory Board's take

Brandi Greenberg, Managing Director and Emily Zuehlke Heuser, Senior Consultant

This new trial failure is just the most recent in a long string of failed trials for drugs aimed at meaningfully affecting the progression of Alzheimer's disease. It reinforces just how hard it is to find therapies that truly inflect outcomes for complex, debilitating conditions like Alzheimer's— a difficulty that's further exacerbated in Alzheimer's by how hard it is to diagnose the disease at an early enough stage to allow potential therapies to have an impact.

 

“The field is still not really closer to success.”

 

Many analysts are wondering if this recent trial will precipitate a pivot away from drugs that attempt to block the buildup of beta-amyloid (a protein that some scientists think is responsible for brain deterioration with the condition) to those targeting other possible causes. Certainly, while scientists may not be ready to give up on treatments targeting the protein, it's become harder for pharmaceutical companies to convince Wall Street to continue with the 'amyloid hypothesis.' Regardless, this recent failure shows how much the field is in flux and that there's unlikely to be any silver bullet cure for Alzheimer's anytime soon. Rather, we've seen that, despite millions having been poured into finding treatments for the condition in the past few years, the field is not really closer to success.

For providers, this should be especially concerning. As life expectancy increases and the baby boomer generation reaches Medicare age, the number of Americans diagnosed with dementia—particularly Alzheimer's disease—is projected to skyrocket. Currently, 5.7 million Americans have Alzheimer's—a figure expected to rise to 14 million by 2050.

Providers need to make sure they are prepared to address this rise and meet the unique needs of patients with dementia. Here are 5 ways they can begin to prepare:

  1. Educating the community about the condition

    Providers can play a valuable role in the community by providing patients and their caregivers with information about early detection of dementia. This education is pivotal for encouraging early detection and decreasing the cost burden of dementia care—as a patient with mild symptoms costs $18,400 to treat annually, whereas a patient with severe symptoms costs up to $36,132 on average.

    Our research on baby boomers indicates that they are highly apprehensive about developing the condition—in one survey 87% of boomers said they were 'extremely' or 'very concerned' about staying mentally sharp in the future—and are highly receptive to education about early detection. Therefore, this education is not only appreciated, but can also brand your hospital as a go-to dementia provider.

  2. Strengthening staff skills

    Dementia patients require unique skills among care staff, who can best excel in providing high-level care when they fully understand the condition and its progression. Your organization can encourage staff to exceed state requirements for dementia training by becoming a Certified Dementia Practitioner or taking other Alzheimer's and dementia trainings offered through the National Council of Certified Dementia Practitioners

  3. Creating cross-service line dementia care teams

    Cross-service line care teams can help to improve care coordination for dementia patients and make their hospital experience less overwhelming and stressful. For instance, at New York-Presbyterian Hospital, dementia patients receive care from a multidisciplinary team of healthcare professionals including neurologists, neuropsychologists, social workers, nurse practitioners, and rehabilitation specialists. In addition to screening and treatment services, this team provides neuropsychological assessments, patient and caregiver education, and assistance in managing patient care.

  4. Promoting treatment in outpatient settings

    Work with PCPs to encourage dementia patients to seek care at outpatient centers. Although patients can still feel disoriented and confused in outpatient clinics, these sites of care tend to be less overwhelming and upsetting to dementia patients than inpatient settings.

    When possible, you can structure consultations or tests to be conducted in outpatient facilities before inpatient admission. Learn more about outpatient geriatric assessment centers and geriatric emergency departments if you're interested in alternative options for better accommodating dementia patients.

  5. Demystifying the discharge process

    Create easily-understandable, printed discharge materials about planning for future care for dementia patients and their caregivers. A JAMA study found that even elderly patients without dementia struggle to understand normal discharge directions. Materials written at an accessible reading level and accompanied by pictures can help patients and their caregivers understand post-treatment procedures and how to prevent complications.

To learn the best practices in creating a dementia program, download our research report on Building a Financially Sustainable Alzheimer's Disease & Memory Disorders Program.

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