Research from LCP Health Analytics and Trinity College Dublin highlights the importance of aligning clinical trials and real-world data in Alzheimer’s disease to enable faster access approvals

As the pipeline of disease-modifying therapies (DMTs) for Alzheimer’s disease accelerates, a new study published today by LCP Health Analytics and Trinity College Dublin, in collaboration with Novo Nordisk, introduces a new method for comparing evidence across clinical trials and real-world studies to improve outcomes for patients with Alzheimer’s disease.

Published in the scientific journal Alzheimer’s & Dementia, the research maps two commonly used cognitive assessments: the Mini-Mental State Examination (MMSE) and the Clinical Dementia Rating – Sum of Boxes (CDR-SB). The aim of the mapping is to allow users to translate scores from one assessment tool to the other. These measures are often used independently in clinical trials and clinical practice, making comparing results across different studies challenging. This paper addresses that gap, providing a complete mapping to translate measurements of clinical severity across data from clinical trials, real-world evidence, and clinical practice.

The model was developed using MMSE and CDR-SB scores from 26,729 patients in the US National Alzheimer’s Coordinating Centres (NACC) database. The mapping demonstrated strong performance, particularly in the earlier stages of the disease.

Looking ahead, the mapping offers different opportunities. It can support randomised controlled trials (RCTs) by enhancing feasibility assessments and extending the use of routinely collected data to track long-term outcomes. Additionally, the model has the potential to play a critical role in standardising evidence submitted for health technology assessments (HTAs) across markets.

Dr Ben Bray, Partner and Evidence Generation Lead at LCP Health Analytics, said: “Our goal was to create a reliable, universal method for translating between MMSE and CDR-SB, enabling researchers and decision-makers to understand results across a fragmented evidence landscape better.

“As we enter a new era of disease modifying therapies in dementia, timely and accurate ability to compare varying sources of evidence will be critical to allow fast market access approvals and quicker access for patients.”

Dr Andrew Thompson, Senior Epidemiologist at LCP Health Analytics, commented: “As new Alzheimer’s treatments emerge, this mapping is more important than ever. This work helps lay the foundation for a more connected evidence base, supporting faster and more effective decision-making in research, regulation, and clinical care.”

Dr Dominic Trépel, Associate Professor of Health Economics at the Global Brain Health Institute and School of Medicine at Trinity College Dublin, said: “As breakthrough drug treatments for Alzheimer’s and dementia are becoming increasingly likely, regulators worldwide must compare new and existing treatments in deciding to recommend market authorisation. This collaboration between Trinity College Dublin and the Danish pharmaceutical company, Novo Nordisk, is an example of Industry-University Collaboration that produces high quality and rigorous scientific output.”