[Editor’s note: This story originally was published by Real Clear Health.]
By Howard Fillit, M.D.
Real Clear Health
Here are some staggering facts: nearly six million Americans currently live with Alzheimer’s disease, and the number of people living with the disease doubles every five years after age 65. Despite these massive numbers, 99% of patients eligible for clinical trials testing new treatments are never referred to a clinical trial or even consider participating in one. Trial participation rates are even lower among Black, Hispanic, and Asian candidates.
Without patients willing to enroll, there can be no clinical trials. And without clinical trials, it is impossible to approve new treatments. Though participating in clinical trials poses some very real challenges for patients, there are some very real incentives to make them worthwhile.
Today’s clinical trials are more precise and, therefore, more likely to succeed. They now offer access to the widest array of experimental therapies that target more of the many underlying causes of Alzheimer’s disease, including inflammation, vascular problems, and metabolic dysfunction. These are not the one-size-fits-all clinical trials of ten or even five years ago.
Challenges to participating in Alzheimer’s clinical trials
To evaluate whether a drug is working, clinical trials ask every participant to follow the same strict guidelines. This can be challenging for Alzheimer’s patients because the clinical trials treat the same illness that hampers their memory and cognitive skills, which are essential for following instructions. For this reason, Alzheimer’s clinical trials always require an available caregiver, most often an elderly spouse, which can add a further layer of logistical complexity.
Like most clinical trials, those for Alzheimer’s also require regular in-person meetings so researchers can monitor participant progress. Travel can be challenging for aging Alzheimer’s patients and their caregivers. In addition, phase 3 Alzheimer’s trials—the ones that prove whether a treatment works or not—usually take years to complete.
Patients and caregivers are asked to make a years-long commitment when joining a clinical trial. In exchange, they may benefit from early access to state-of-the-art experimental therapies and care. Even those who only receive a placebo still benefit from regular visits with experts and the knowledge that they are contributing to the progress of important science, bringing us closer to effective Alzheimer’s treatments.
For a progressive disease like Alzheimer’s, an early start on therapy can make an enormous difference. In the best scenario, we want to stop or at least slow the disease early. That may happen in the preclinical stage— before patients exhibit symptoms —or in the mild cognitive impairment stage when symptoms are often attributed to “normal” aging.
Slow patient recruitment can increase already long and costly Alzheimer’s trials
Alzheimer’s is complex and so are its clinical trials. Compared to trials for other diseases, Alzheimer’s trials are slower to enroll participants, take longer to complete, and are more expensive.
Well-designed clinical trials are our best opportunity to gather information on how people of different ages, races and ethnicities respond to medical treatments. But, in order to fully benefit from Alzheimer’s clinical trials, we need to speed up the process and increase enrollment, especially among individuals who represent the diversity of the U.S. population.
Today’s trials are succeeding
This is an exciting time for Alzheimer’s research. The latest clinical trials are establishing a new research model, which combines clinical measures—like changes in memory and the ability to complete certain tasks— with measures of how experimental treatments work inside the body.
This new model is being replicated by more new trials every day and was made possible by incredible advances in medical technology and diagnostic tools (also called biomarkers) over the past decade. Biomarkers such as the Amyvid™ PET brain imaging scan, which was approved in 2012, can measure whether drugs that aim to remove amyloid plaques in the brain are actually having an effect.
Other types of brain scans, blood tests, and spinal fluid taps can also be used to enroll the right patients in clinical trials and to monitor their progress. We are even developing digital biomarkers, which use a variety of technologies including wearable devices and smartphone apps, and which can measure cognition in a less costly and more efficient way than ever before. This means patients can feel confident that they are enrolled in trials with the best chance of helping them.
These advances, and every new one on the horizon, are only possible because of the tens of thousands of patients who have participated in clinical trials.
Alzheimer’s is a complex disease, with the exact combination of factors that contribute to it differing from one patient to the next. By understanding how it works in different people and enrolling a large and diverse population of patients in clinical trials, we will be able to develop more effective methods of prevention, diagnosis, and treatment.
Howard Fillit, M.D. is the Founding Executive Director and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF).
[Editor’s note: This story originally was published by Real Clear Health.]
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