Expert panel identifies critical challenges in recruiting study participants

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Unless cures are found, Alzheimer’s dementia is projected to affect nearly 13 million Americans by 2050, overwhelming families, caregivers, and our health care system. However, only one new therapy, aducanumab, has come to market in the past 20 years, and therapeutic progress remains hampered for several reasons: Recruiting study participants into clinical trials for Alzheimer’s disease is more difficult than in other areas of disease, trials take longer to complete and are more expensive. A significant increase in the number of qualified volunteers from diverse backgrounds will be needed in the coming years for clinical trials for Alzheimer’s disease to be successful.

To develop solutions that overcome some of the steepest barriers to recruitment, the USC Schaeffer Center for Health Economics and Policy and the Alzheimer’s Therapeutic Research Institute (ATRI) joined Gates Ventures to convene more than 35 experts from the public and private sectors. The advisory panel was chaired by Julie Zissimopoulos, Paul Aisen, and Jessica Langbaum. An article published in Alzheimer’s and dementia identifies actionable and inclusive solutions to accelerate the development of new therapies for Alzheimer’s disease that resulted from the panel.

The most pronounced barriers to more efficient Alzheimer’s clinical trials are those that prevent potential volunteers from participating in the first place.”

Julie Zissimopoulos, Co-Director, Aging and Cognition Program, Schaeffer Center for Health Economics and Policy, University of Southern California

“Lowering these barriers to support progress in Alzheimer’s treatments, even modest progress, would have a profound impact on communities affected by this disease.”

“There is no answer,” says Aisen, who runs ATRI and oversees many clinical trials. “These issues need to be tackled from multiple angles. Recruitment, however, is the main bottleneck.”

Current models prevent approximately 99% of eligible volunteers from being referred or considering trial enrollment. Black and Latino populations are especially underrepresented, even though they face higher risks of Alzheimer’s disease than white Americans.

Even if a patient is referred to a clinical trial and considers enrollment, there are additional barriers. Most participants do not meet the screening criteria, leading to failed screening rates of up to 88%. Additionally, some of these exclusion criteria, such as chronic conditions such as cardiovascular disease, may result in the disproportionate exclusion of diverse populations.

“We need to increase the enrollment of diverse populations in Alzheimer’s disease clinical research,” says Langbaum, co-director of the Banner Alzheimer’s Institute-led Alzheimer’s Prevention Initiative. “These communities are disproportionately affected by the disease, and we can learn more about the disease and how best to detect, treat and prevent it if we have diverse representation in studies. But to do this, we must address unique logistics, financial and trust barriers that prevent diverse populations from participating in Alzheimer’s disease research.

The expert panel met over the course of a year to identify critical challenges and potential solutions that are scalable and most likely to turn the tide.

“By bringing together a large and diverse group of thought leaders and stakeholders spanning research, industry, policy and philanthropy, we fostered conversations that would normally happen in silos, resulting in a set of unique and impactful ideas that they address Alzheimer’s trial bottlenecks,” says Desi Peneva, a research leader at the Schaeffer Center who managed the advisory panel project.

Panel suggestions include:

  • Expanding cognitive screening and early detection efforts in both asymptomatic adults and those showing early symptoms of Alzheimer’s disease.
  • Develop better tools for primary care providers to identify populations at risk, recognizing that the disease begins decades before symptoms appear.
  • Change payment models, such as expanding Medicare reimbursement to encourage early diagnosis and clinical trial referrals.
  • Expansion of the use of blood biomarkers for the detection of Alzheimer’s disease.
  • Increase public awareness and outreach with personalized messages to engage diverse communities.
  • Scale clinical trial architecture to bring Alzheimer’s trials to diverse communities by leveraging health system satellite sites, mobile clinical trial units, or local networks of diagnostic clinics.
  • Use digital engagement and a screening failure registry to share information from multiple trial enrollees, as a potential participant who fails screening in one study might be a good fit for other trials.
  • Conducting virtual clinical trials where appropriate to reduce travel burden and time on trial participants; although it would be necessary to provide Internet access to some patients to ensure equitable access.

Implementation of some of these strategies is already underway. The Schaeffer Center and ATRI are spearheading the new Clinical Trials Recruitment Lab, which launched earlier this year and aims to test and evaluate innovative solutions that have the potential to increase access and reduce disparities in clinical trials.


University of Southern California

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