Abstract
INTRODUCTION: Despite the increase in Alzheimer's disease (AD) cases in the United States, no new treatments have been approved in the United States since 2003. The costs associated with drug development programs are high and serve as a significant deterrent to AD therapeutic investigations. In this study, we analyze the sponsorship data for AD clinical trials conducted since 2016 to assess the fiscal support for AD clinical trials. METHODS: We analyzed the funding sources of all AD trials over the past 5 years as reported on ClinicalTrials.gov. RESULTS: There were 136 trials being conducted for treatments in the US AD therapeutic pipeline on the index date of this study. Among non-prevention trials, disease-modifying therapies (DMT) in Phase 3 were almost entirely sponsored by the biopharmaceutical industry; Phase 2 DMT trials were split between the biopharmaceutical industry and funding from the National Institutes of Health (NIH) to academic medical centers (AMCs). The majority of prevention trials received sponsorship from public-private partnerships (PPP). Trials of symptomatic agents are equally likely to have biopharmaceutical or NIH/AMC sponsorship. Most trials with repurposed agents had NIH/AMC funding (89%). Since 2016, there has been consistent growth in the number of trials sponsored both in part and fully by NIH/AMC sources and in PPP, and there has been a reduction in biopharmaceutical company-sponsored trials. DISCUSSION: The number of trials supported by the biopharmaceutical industry has decreased over the past 5 years; trials supported from federal sources and PPP have increased. Repurposed compounds are mostly in Phase 2 trials and provide critical mechanistic information.