Pharma Blog

The growing number of clinical trials and increasing number of drugs in the pipeline are reasons for optimism in the quest for new treatments for Alzheimer’s disease (AD). At the same time, there are concerns that many of the clinical assessments used to evaluate cognition are no longer fit for purpose.

Alzheimer’s researcher Jeffrey Cummings, MD, a neurologist and research professor at the University of Nevada, Las Vegas, notes, “The assessments often date from the 1970s and 1980s, when we had a much less thorough understanding of early disease presentation.” Digital testing offers a solution.

In a new episode of a Pearson-sponsored podcast series, “The Progress Profile: Alzheimer’s Research in Focus,” Cummings joined moderator John Harrison, Ph.D., CPsychol, CSci, AFBPsS, an associate professor at Alzheimercentrum, AUmc, Amsterdam, to share his thoughts on the role of digital testing in Alzheimer’s disease.

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Tracking cognitive functioning remains a critical part of Alzheimer’s disease (AD) and dementia research. When used properly, COAs offer valuable insights into patients’ conditions, helping researchers track patients’ progress and assess a drug’s efficacy throughout clinical trials.

However, choosing suboptimal scales can be catastrophic for clinical research. The cognitive scales used in the majority of clinical trials for AD, for example, have been pivotal to the failure of 98% of Phase 2 and 3 clinical trials.

In this blog, we’ll discuss how COAs can make or break clinical trial outcomes and share how sponsors can select the optimal scales for their AD clinical research programs.

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Growth scale values (GSVs) have gained traction as a more precise option for measuring outcomes in clinical trials.

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Over the last ten years, the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-3), a leading developmental assessment for children ages 1–42 months, has been referenced as an endpoint in 145 clinical trials (Citeline, 2024). Of those, 6.21% have included sites in the Finno-Ugric countries of Estonia, Finland, and Hungary.

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Dr. Lynsey Psimas, Ph.D and Dr. Paul Williams PsyD attended CNS Summit 2023 and were fortunate to have the opportunity to present their poster, Precision Matters: An Analysis on How Various Scores Behave When Measuring Change Over Time; Factors That Inform Score Selection for the Best Results”.

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“Rare Genetic/Monogenic Disorders & Co-Occurring Conditions in Intellectual and Developmental Disabilities”

Each year, Gatlinburg brings together numerous behavioral scientists from around the world to discuss their research and collaborations in related fields such as intellectual and developmental disabilities. While it is a smaller conference, the attendees represent all professional levels and include students, post-docs, support and research staff, professors, and researchers. Our Pharma Services team also attended, excited to learn about the important and ground-breaking research being conducted in the IDD sphere.

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Presenters: Lynsey Psimas, PhD and Paul Williams PsyD

Growth Scale Values (GSVs) have a long 50-year history within research. However, GSVs are only now gaining traction as an alternative and more precise way to measure outcomes in clinical trials.

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In testing and in research, you must have an effective and reliable way to measure change. While raw scores have typically been the go-to for this important role, Growth Scale Values (GSVs) are quickly becoming the preferred method.

Our Director of Pharma Sales, Lynsey Psimas, had the opportunity to speak with Mark Daniel, author of Growth Scale Value (GSV): Theory, Development, and Applications to discuss the importance of GSVs. He spent some time explaining GSVs and their importance in test scoring and pharma research.

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