Skip to main content

Finding Clinical Meaningfulness in CDR-SB Scores

With an increasing number of FDA-approved treatments for early symptomatic Alzheimer’s disease coming to market, there’s a growing need to understand the real-world implications of changes observed in clinical trials. Research presented during the poster session at the 2023 Clinical Trials on Alzheimer’s Disease conference addressed this issue.

Specifically, researchers explored attaching clinical meaningfulness to changes in the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) scores in AD clinical trials.


CDR-SB serves as a primary endpoint in many Alzheimer’s disease (AD) clinical trials, particularly those evaluating early symptomatic stages. However, it is less commonly used in regular clinical practice.

This discrepancy raises questions about the clinical significance of minor score changes between treatment and placebo groups. Researchers hoped to clarify the real-life implications of these changes for patients and their families.

About the Study

The research investigated the correlation between CDR-SB scores and functional abilities, using the Amsterdam Independent Activities of Daily Living (A-IADL) scale. This approach offers fresh insights into interpreting clinical trial results, focusing on the practical challenges faced by those living with AD.

The study analyzed data from seven secondary prevention and early symptomatic AD trials involving biomarker-positive participants, yielding 6,452 pairs of CDR-SB and A-IADL scores. Notably, the analysis identified specific functional losses associated with each incremental increase in CDR-SB score.

Findings and Implications

The study revealed a significant correlation between CDR-SB scores and specifc functional losses in the participants, shedding light on the real-world consequences of score changes in clinical trials. This understanding is vital for determining what constitutes meaningful progression in AD and can inform both clinical practice and future research.

The findings emphasize the value of real-world data in interpreting the clinical relevance of CDR-SB score changes on participant functioning. Particularly in the context of emerging treatments, according to the authors, the results presented concrete, real-world understanding of the association between CDR-SB scores and functional status in AD trial participants.

Schedule a consultation with our experts

There’s no time for doubt or delays. WCG’s clinical endpoint solutions demystify trial efficacy by reducing clinical trial error rate and, subsequently, the risk of inconclusive and unsalvageable studies. Complete the form to schedule complimentary consultation with our experts today. We’ll help assess your need, and discuss how WCG can assist.