In It Together: Encouraging Greater Participation in Alzheimer’s Clinical Trials
Prevention or treatment of Alzheimer's disease can only happen with the generosity and commitment of volunteers enrolling in clinical trials.
The entire clinical and research community, along with support from the government, nonprofit and industrial sectors, is coming together to tackle the challenge of how to encourage greater participation in research studies.
With Alzheimer's disease and other dementias, the recruitment process can be complicated, due to the need in some trials for the enrollment of participants as a "dyad." This is the pairing of an affected individual and a caregiver (whether that is a spouse, family member, or other person) who are both committed to the clinical trial process.
A further level of complication is that some studies recruit individuals before the signs of cognitive issues have begun or as they are just starting (the so-called pre-symptomatic or prodromal/MCI stages). Many trials may need participation from individuals not currently affected by the disease and, understandably, volunteering for an Alzheimer's trial may not be their top priority.
One potential change to allow more volunteers to participate is to lift some of the strict exclusion criteria on certain trial protocols, as long as it doesn't compromise the ability of the researchers to interpret the study results.
Another adaptation would be to use sophisticated crossover study design to reduce the number of participants needed to enable statistically significant results. BrightFocus has recognized that recruitment is an issue, and has contributed to the solution by funding a number of clinical studies where modern crossover trial designs were created and tested. We are also funding a research group to strategically test ways to improve recruitment to prodromal Alzheimer's disease clinical trials.
Other ways to encourage participation are more pragmatic, especially for trials involving dyad, pre-symptomatic or prodromal recruitment where affected individuals and their caregivers may still be working, unable to drive, or engaged in other life pursuits. Some strategies for greater participation include: conducting more studies at night or on the weekend; using easily-available transportation, like taxis, Lyft or Uber, to assist participants getting to and from the scheduled trial visits; and having places of employment offer paid time off for caregivers.
Ultimately, having a cheaper and more accessible fluid-based biomarker test, in addition to the current brain imaging biomarker tests, will revolutionize the ability of clinicians and researchers to better identify those individuals who are eligible to participate. This is another area where BrightFocus has funded, and will continue to fund, the most innovative ideas to propel these ideas forward.
We need to better engage clinicians, researchers, government, non-profit and industry leaders through greater education and communication. To this end, we have a short guide, Clinical Trials: Your Questions Answered which can be found here.
With more than 5 million Americans diagnosed with Alzheimer's disease, at least 50 million people living with Alzheimer's or other dementias around the world, and more than 15 million Americans providing unpaid care for someone with Alzheimer's or other dementias, nearly all of us are connected in some way to persons with these diseases. If we all work together and contribute in our own way to finding a prevention, treatment or cure, we can someday make Alzheimer's a thing of the past.
Diane Bovenkamp, PhD, is Vice President for Scientific Affairs at BrightFocus Foundation, a premier source of private research funding for Alzheimer's, macular degeneration, and glaucoma. BrightFocus is a presentation partner for Turning Point, a new documentary by James Keach that follows a clinical trial seeking to slow and treat Alzheimer's.