With AD Drug Failures, Non-Pharma Efforts Become More Critical

Lisa Henderson

The Phase III failure and discontinuance of Biogen’s aducanumab for Alzheimer’s disease sealed the fate for drug development concerning the amyloid “plaque” build-up theory around the condition’s cause. As Dr. RJ Tesi explained

in this article

, amyloid “went from being a biomarker of the disease to the cause of the disease”-even when data to prove this was lacking. Tesi and others believe it’s time to rethink what actually is Alzheimer’s disease.

Theories abound. Alzheimer’s as an immunologic disease caused by neuroinflammation; Alzheimer’s caused by infection, metabolic disorder, or environmental toxins-all with the underlying connection of aging. Alzheimer’s also might not be one disease, and like cancer, would need combination drugs to effectively treat it. Factor in, again, the lack of biomarker or effective diagnosis-for example, vascular dementia and Lewy body dementia exhibit as Alzheimer’s in patients-as well as the crisis of clinical trial enrollment, and the research paradigm looks grim.

Last fall, I spoke with George P. Sillup, PhD, associate professor, pharmaceutical and healthcare marketing at Saint Joseph’s University, about non-pharmaceutical interventions in Alzheimer’s. According to Sillup, there are 1.3 million nursing home residents, and up to half have some kind of cognitive impairment. While one might assume that it would be easier to conduct a clinical study or enroll through or in a nursing home, that is not the case. Sillup says there is a hesitancy among the facilities, which have clients that don’t get regular family visits or have relegated their powers of attorney. Also, according to Cherian Verghese, MD, a neurologist and medical director and principal investigator of Keystone Clinical Studies, clinical trial enrollment is difficult because of a lack of awareness, as well as the separation between healthcare and clinical trials, which does not foster collaboration of care.

For those that work for or with nursing care facilities, the lack of pharmaceutical interventions for Alzheimer’s means a greater reliance on non-traditional medicines, or physical and mental exercise. Soffy Vilson, chief nursing officer for Parker Life, an aging services organization, says they work to stimulate the elders’ brains and engage with them often. “We pride ourselves on taking the time with their home visit. We ask how did they live? How are things arranged in their house? Where are their pictures? How is the bed positioned? And we try to replicate that in their new environment.” Vilson believes the increased attention on exercise, diet, and environment provides a necessary holistic approach to care.

Susan Cade and Tatyana Shargorodsky, founders of Senior & Chair Ballet, are firm believers that movement and exercise is key to longevity and happiness for all elderly people, not just those with Alzheimer’s. But for those that need memory care, Cade and Shargorodsky have witnessed first-hand the changes those individuals experience listening to music, moving their hands, or singing. “Often, they are isolated, or they are experiencing agitation or fear or anxiety because of their condition,” says Cade. “But during these sessions, their body language changes. They are distracted from their pain or isolation.”

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mmhgroup.com. Follow Lisa on Twitter: @trialsonline