Experts Discuss Assessing Meaningful Benefits in Early Alzheimer’s Disease (AD)
Watch to learn about the evolving concept of meaningful benefit in AD, measurement of meaningful benefit in clinical trials and clinical practice, and applying a holistic approach that incorporates various stakeholder perspectives.
The new era of AD management applicable to individuals in the early stages of the disease, has necessitated a redefinition of clinical benefit and meaningful benefit.
Presented at the 2024 Alzheimer’s Disease/Parkinson’s Disease (AD/PD™) conference, three leading experts in AD discuss the evolution from clinical meaningfulness to meaningful benefit; review how meaningful benefits are measured in AD clinical trials; present a new framework for assessing meaningful benefits in the evolving AD treatment landscape; and discuss various stakeholders’ perspectives.
1. Dr. Jeffrey Cummings: Clinical meaningfulness and meaningful benefit: Evolution of approaches
As individuals with Alzheimer’s Disease (AD) are being diagnosed and managed earlier in their disease progression, the definition of clinical meaningfulness has evolved.
Dr. Jeffrey Cummings provides an overview of clinical meaningfulness in the AD landscape, covering key domains, measures, and regulatory guidance. He introduces the concept of meaningful benefit and its relevance to early AD populations. Dr. Cummings emphasizes the importance of using a holistic framework with multiple domains, analytical approaches, and stakeholder perspectives to comprehensively measure meaningful benefit.
2. Dr. Robert Perneczky: Assessing meaningful benefits in the new era of AD management
Emerging treatment options are changing the approach of AD management from addressing symptoms to targeting the underlying AD pathology in individuals at earlier stages in their disease.
Dr. Robert Perneczky explores the assessment of meaningful benefits from therapies targeting AD pathology. He discusses the potential cumulative advantages of early disease modification and how to capture the “time saved” by delaying disease progression. Dr. Perneczky highlights the value of integrating global measures and patient perspectives to enhance the interpretation of meaningful benefits.
3. Dr. Miia Kivipelto: Stakeholder perspectives and future outlook of meaningful benefits in AD
Evaluating meaningful benefits necessitates a comprehensive approach that incorporates various stakeholder perspectives along with specific measures designed to describe delayed progression in early AD.
Dr. Miia Kivipelto outlines the specific and shared outcomes of interest related to meaningful benefit among different stakeholders including patient and care partners, advocacy groups, healthcare systems and providers, society and payors, and regulatory agencies. She also discusses the future outlook of meaningful benefits in AD that incorporates a personalized precision medicine approach.
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