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Biopharma Support for Alzheimer Disease Trials Has Decreased In Recent Years

SAP Partner | <b>Cleveland Clinic</b>

Since 2016, there has been consistent growth in the number of Alzheimer disease trials sponsored both in part and fully by academic medical centers and/or the National Institutes of Health.

An overview of the funding sources of all Alzheimer disease (AD) trials over the past 5 years showed a decrease in the number of trials supported by the biopharmaceutical industry, while trials from federal sources and public-private partnerships (PPP) have increased in that time frame.

Lead author Jeffrey Cummings, MD, ScD, director emeritus, Lou Ruvo Center for Brain Health, Cleveland Clinic, and vice-chair, Department of Brain Health, University of Nevada–Las Vegas, and colleagues analyzed the funding of 136 active AD trials between 2016 and the index date of review (February 27, 2020). This included 110 trials of disease-modifying therapies (DMTs), 15 trials of drugs seeking to reduce neuropsychiatric symptoms, and 11 trials of drugs targeting cognitive enhancement.

Investigators documented a 16% decrease in the number of trials sponsored solely by biopharmaceutical companies; however, they noted that there was variability, with some years showing increases. Trends in trial sponsorship over the last 5 years showed a consistent increase in the number of academic medical centers (AMCs)- and/or National Institutes of Health (NIH)-funded trials over the observation period, from 27 in 2016 to 48 in 2020. Likewise, there was a steady increase of PPP trials, from 6 in 2016 to 22 in 2020.

Of phase 3 DMT trials, 100% had industry participation and 11 of 14 are sponsored solely by biopharmaceutical companies. Sponsorship of phase 2 trials was more heterogenous, with many more AMC/NIH trials (21 in phase 2 vs 0 in phase 3) and somewhat more trials in each of the other sponsor categories (19 biopharmaceutical in phase 2, 12 in phase 3; 9 PPP in phase 2, 3 in phase 3; 1 “other” in phase 2, 0 in phase 3).

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There was an 89% increase in DMT trials sponsored by AMCs/NIH, while a 2% decrease was observed for trials funded by the biopharmaceutical industry. A 3-fold increase in DMT trials from PPP sponsors was observed and there was no change in the number of DMT trials sponsored by other entities.

"This study of funding for clinical trials in AD provides the foundation for recommendations for how best to increase the number and value of AD trials. AMC/NIH-funded trials are increasing, and that trend should be sustained and championed,” Cummings et al wrote. “PPP are growing in number and offer advantages to all collaborators including biopharmaceutical enterprises and AMC/NIH; these collaborations should be supported and expanded."

Overall funding by biopharmaceutical companies decreased from 67% to 20% for cognitive enhancer and neuropsychiatric trials, whereas there was an increase from 25% to 250% in these trials sponsored by AMC/NIH. For PPP trials, there is currently 1 cognitive-enhancing trial and none investigating behavioral or neuropsychiatric symptoms.

There are 36 trials of repurposed agents with disease-modifying objectives in the current pipeline. A 3-fold increase in the number of AMC/NIH-sponsored trials was observed for these agents, as well as a 7-fold increase in PPP-sponsored trials. Trials of repurposed drugs sponsored by biopharmaceutical companies and other entities remained constant throughout the study period.

A total of 7 trials, 5 in phase 3 and 2 in phase 2, involving cognitive normal preclinical participants and examining prevention or delay of symptomatic AD were identified in the 2020 pipeline. Most of the prevention trials in phase 3 (3 of 5) are sponsored by the PPPs and have a recruitment period of 216 weeks, treatment duration of 236 weeks, and 273 participants per treatment arm.

Phase 3 trials tended to take longer to recruit when biopharmaceutical companies were the sole sponsor. The total trial time equaled 204 weeks for pharmaceutical trials compared to 96 weeks for the PPP trials. Additionally, these pharmaceutical trials were also larger in number of participants (416 vs 258 per arm) and have a somewhat shorter drug treatment period (79 vs 77 weeks).

Cummings has been at the forefront of evaluating the AD pipeline by publishing a systematic review each year. In 2020, his research demonstrated the progressive emphasis on nonamyloid targets, including candidate treatments for inflammation, synapse and neuronal protection, vascular factors, neurogenesis, and epigenic interventions. Listen to our conversation with Cummings below as he details trends in AD research.

REFERENCE
Cummings J, Bauzon J, Lee G. Who funds Alzheimer’s disease drug development? Alzheimers Dement. Published on May 25, 2021. doi: 10.1002/trc2.12185