In the world of Alzheimer’s disease research, few reports are as anticipated each year as Dr. Jeffrey Cummings’s review of the therapeutic development pipeline. Over the course of almost a decade, his annual report has tracked a remarkable growth in the number and diversity of Alzheimer’s drug candidates—a trend that inspires hope but also concern.
A quick snapshot tells the story of this progress. In 2016, the first year of the report, there were 24 agents in Phase III development, three-quarters of which targeted buildup of amyloid proteins in the brain. While amyloid was the first druggable and measurable target—and we now have two FDA-approved amyloid-clearing therapies that can slow Alzheimer’s—a broad range of approaches is needed to overcome this complex disease. This year’s report finds there are over 180 clinical trials in the pipeline aimed at 15 different disease processes. The opportunity to advance innovation and help patients is astounding, if only we can ensure speedy, representative and robust trials.
We know from USC Schaeffer Center research that Alzheimer’s trials are indeed longer, slower and more costly to recruit than other therapeutic areas, including other neurological disorders. There are many reasons for this, including beliefs and stigma in the community, a systemwide lack of timely detection of cognitive impairment, and a lack of access to diagnostics that can reduce challenges for an accurate diagnosis, among many other administrative hurdles. These findings led to the formation of USC’s Clinical Trial Recruitment Lab (CTRL) to test and share innovative strategies for improving access and representation in clinical trials.
Of the millions of Alzheimer’s patients potentially eligible for clinical trials, only about 12,000 enroll each year—well short of the 50,000-plus participants that are needed to fully enroll the 182 clinical trials in the 2025 pipeline. The math is simple: If we don’t do something to make clinical trials statically more efficient and require fewer patients, or increase the speed of recruitment, this work will take far too many years.
Enrolling more patients and more diverse patients in clinical trials raises the chances of a breakthrough that slows the progression of the disease in more people. However, many may never get that chance unless we can better identify potential participants in the first place.
Many adults who show clear signs of Alzheimer’s or other forms of dementia never receive a diagnosis. Not only are these patients not receiving the care and support they and their families need, they are also precluded from participating in clinical trials if they would choose to do so. Polling shows most American adults are interested in joining Alzheimer’s clinical trials, but less than 10% of diagnosed patients are actually participating. Qualitative research in The Gerontologist showed participants feel that clinical trial involvement transforms them “from Victimhood to Warriors,” reinforcing the personal accounts that many of us hear in the clinical trial setting.
CTRL recently launched a request for applications to use technology-enabled solutions, such as artificial intelligence and machine learning, to speed clinical trial recruitment. There are broad possibilities. For example, technology can be used to reduce administrative hurdles, and advancements in risk projection can help better identify potential trial participants who meet inclusion criteria and are likelier to enroll.
There will not be one solution that addresses every recruitment barrier, but the scientific innovation curve in front of us is too exciting to ignore. Faster completion of clinical trials increases our understanding of Alzheimer’s and our ability to find treatments and a cure. Patients are waiting.
Phyllis Barkman Ferrell is a Nonresident Scholar at the USC Schaeffer Institute for Public Policy & Government Service.
