Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials

Jessica B Langbaum; Julie Zissimopoulos; Rhoda Au; Niranjan Bose; Chris J Edgar; Evan Ehrenberg; Howard Fillit; Carl V Hill; Lynne Hughes; Michael Irizarry; Sarah Kremen; Darius Lakdawalla; Nancy Lynn; Kristina Malzbender; Tetsuyuki Maruyama; Holly A Massett; Deep Patel; Desi Peneva; Eric M Reiman; Klaus Romero; Carol Routledge; Michael W Weiner; Stacie Weninger; Paul S Aisen

doi:10.1002/alz.12737

Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials

Alzheimers Dement. 2023 Feb;19(2):696-707. doi: 10.1002/alz.12737. Epub 2022 Aug 10.

Authors

Jessica B Langbaum¹, Julie Zissimopoulos², Rhoda Au³, Niranjan Bose⁴, Chris J Edgar⁵, Evan Ehrenberg⁶, Howard Fillit⁷, Carl V Hill⁸, Lynne Hughes⁹, Michael Irizarry¹⁰, Sarah Kremen¹¹, Darius Lakdawalla¹², Nancy Lynn¹³, Kristina Malzbender⁴, Tetsuyuki Maruyama¹⁴, Holly A Massett¹⁵, Deep Patel¹⁶, Desi Peneva¹², Eric M Reiman¹, Klaus Romero¹⁷, Carol Routledge¹⁸, Michael W Weiner¹⁹, Stacie Weninger²⁰, Paul S Aisen²¹

Affiliations

¹ Banner Alzheimer's Institute, Phoenix, Arizona, USA.
² Sol Price School of Public Policy and Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, California, USA.
³ Departments of Anatomy & Neurobiology, Neurology and Epidemiology, Boston University Schools of Medicine and Public Health, Boston, Massachusetts, USA.
⁴ Gates Ventures, Kirkland, Washington, USA.
⁵ Cogstate Ltd, Reading, UK.
⁶ Clara Health, San Francisco, California, USA.
⁷ Alzheimer's Drug Discovery Foundation, New York, New York, USA.
⁸ Alzheimer's Association, Chicago, Illinois, USA.
⁹ Lynne Hughes Consulting, Berkshire, UK.
¹⁰ Eisai, Woodcliff Lake, New Jersey, USA.
¹¹ The Jona Goldrich Center for Alzheimer's and Memory Disorders, Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
¹² Leonard D. Schaeffer Center for Health Policy and Economics, University of Southern California, Los Angeles, California, USA.
¹³ BrightFocus Foundation, Clarksburg, Maryland, USA.
¹⁴ Alzheimer's Disease Data Initiative, Kirkland, Washington, USA.
¹⁵ National Institute on Aging, Bethesda, Maryland, USA.
¹⁶ IQVIA, New York, New York, USA.
¹⁷ Critical Path Institute, Tucson, Arizona, USA.
¹⁸ Small Pharma Ltd, London, UK.
¹⁹ Departments of Radiology and Biomedical Imaging, Medicine, Psychiatry, and Neurology, University of California San Francisco, San Francisco, California, USA.
²⁰ FBRI, Cambridge, Massachusetts, USA.
²¹ Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, California, USA.

Abstract

Clinical trials for Alzheimer's disease (AD) are slower to enroll study participants, take longer to complete, and are more expensive than trials in most other therapeutic areas. The recruitment and retention of a large number of qualified, diverse volunteers to participate in clinical research studies remain among the key barriers to the successful completion of AD clinical trials. An advisory panel of experts from academia, patient-advocacy organizations, philanthropy, non-profit, government, and industry convened in 2020 to assess the critical challenges facing recruitment in Alzheimer's clinical trials and develop a set of recommendations to overcome them. This paper briefly reviews existing challenges in AD clinical research and discusses the feasibility and implications of the panel's recommendations for actionable and inclusive solutions to accelerate the development of novel therapies for AD.

Keywords: Alzheimer's disease; clinical trials; diversity in clinical trials; recruitment; retention; trial participation.

Recommendations to address key recruitment challenges of Alzheimer's disease clinical trials

Authors

Affiliations

Abstract

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MeSH terms

Grants and funding