PHOENIX (Aug. 16, 2022) – A high-level panel of experts has issued recommendations to accelerate recruitment for Alzheimer’s disease clinical trials. There is growing urgency to increase awareness and recruitment for studies on Alzheimer’s disease, many of which need to enroll healthy volunteers as well as people with the disease, to find effective treatments and preventive strategies. Their conclusions were published in Alzheimer’s & Dementia, the Journal of the Alzheimer’s Association.
“Alzheimer’s trials are slower to enroll participants, take longer to complete, and are more expensive than studies in other therapeutic areas,” said lead author Jessica Langbaum, PhD, co-director of the Alzheimer’s Prevention Initiative led by Banner Alzheimer’s Institute. “If widely implemented, these evidence-based recommendations could help speed clinical research on this debilitating, fatal disease.”
Alzheimer’s threatens to overwhelm the health system, as well as the families who often serve as the caregiver for a person with the disease. An estimated 6.2 million Americans are currently living with Alzheimer’s, and this number is expected to nearly double by 2050. Research suggests that early interventions could greatly reduce the prevalence of dementia, cutting the number of people in 2050 who have the disease by 42 percent. Even a modest delay in the onset of the disease could prevent millions of families from experiencing this devastating disease while also generating billions in savings to society.
Only one therapeutic, aducanumab, has been approved by the Food and Drug Administration over the past two decades. The authors note that if barriers are not reduced for clinical trial enrollment, the discovery of new preventive and therapeutic treatments will be seriously delayed.
The University of Southern California Schaeffer Center for Health Policy & Economics, Alzheimer’s Therapeutic Research Institute (ATRI), and Gates Ventures convened the panel to assess crucial challenges in AD clinical trials, particularly recruitment bottlenecks. Chaired by Dr. Langbaum, Paul Aisen, MD, of USC ATRI and Julie Zissimopoulos, PhD, of USC Schaeffer Center, the panel included more than 35 national and international experts from academia, industry, patient advocacy, philanthropy, nonprofit, and government.
“The steepest barriers to more efficient Alzheimer’s clinical trials are those that are keeping potential volunteers from ever participating in the first place,” says Zissimopoulos, co-director of the Aging and Cognition Program at the USC Schaeffer Center. “Reducing these barriers to support progress on AD treatments —even modest progress—would have a profound impact on the communities affected by this disease.”
After a two-year process, the panel recommended 27 solutions across six categories – ranked by feasibility, capacity to reduce recruitment barriers, and potential to improve diversity in the populations participating in Alzheimer’s research:
- Cognitive screening and early detection to ensure that a lack of formal Alzheimer’s diagnosis does not rule out potential participants from trial eligibility. This includes prescreening strategies (e.g., early detection in primary care to refer more people to trials) and other health system solutions (e.g., incentivizing early diagnosis);
- Blood-based biomarker testing to enable low-cost screening in a wider range of settings;
- Public awareness and outreach for better understanding that Alzheimer’s disease starts decades before symptoms appear, emphasizing the importance of early detection and need for healthy, at-risk adults to participate in research, and improving the inclusion and health equity in research;
- Clinical trial architecture in the community, through health system satellite sites, mobile clinical trial units, and diagnostic clinic networks – to build trust in clinical research, increase screening, and reduce transportation barriers for participants;
- Screen-fail registry and digital engagement to maintain contact with those who do not qualify for a particular trial, so they may be contacted about other future trials; and
- Virtual clinical trials, to recruit more widely and enable more trial activities in participants’ homes.
“The critical barriers facing these clinical trials today can be overcome when stakeholders from academia, industry, philanthropy, government, and volunteers work together to address this immense public health challenge and find novel ways to expedite the development of Alzheimer’s treatment and prevention therapies,” Langbaum added.
About Banner Alzheimer’s Institute
Since its inception in 2006, Banner Alzheimer’s Institute (BAI) has sought to find effective Alzheimer’s disease prevention therapies without losing another generation, to establish a new model of dementia care for patients and family caregivers, and to forge new models of collaboration in biomedical research. It has made groundbreaking contributions to the unusually early detection, tracking, diagnosis, and study of Alzheimer’s, and aims to find an effective prevention therapy by 2025. It includes the pioneering Alzheimer’s Prevention Initiative (API), an extensive profile of research studies and clinical trials, comprehensive clinical, family and community service programs, a leading brain imaging research program, and strategic partnerships with numerous public and private research organizations around the
world. Learn more at www.BannerAlz.org.
About the Alzheimer’s Prevention Initiative
The Alzheimer’s Prevention Initiative (API) is an international collaborative formed in 2009 to launch a new era of Alzheimer’s prevention research. Led by Banner Alzheimer’s Institute, the API conducts prevention trials in cognitively healthy people at increased risk for Alzheimer’s disease. API continues to establish brain imaging, fluid biomarker and cognitive endpoints needed to rapidly test promising prevention therapies. It also leads participant recruitment registries to accelerate enrollment into Alzheimer’s-focused studies. API is intended to provide the scientific means, accelerated approval pathway and enrollment resources needed to evaluate the range of promising Alzheimer’s prevention therapies and find ones that work without losing another generation. For more information about the recruitment registries, visit endALZnow.org.