Building clinically relevant outcomes across the Alzheimer's disease spectrum

Area of Science:

• Neuroscience
• Clinical Research
• Health Policy

Background:

• Achieving a cure for Alzheimer's disease (AD) by 2025 necessitates demonstrating clinically meaningful treatment effects.
• Current understanding of
• clinically meaningful outcomes
• in AD lacks consensus across patient, clinician, and regulatory groups.

Purpose of the Study:

• To review and synthesize various perspectives on defining clinical meaningfulness in Alzheimer's disease.
• To foster discussion on establishing consensus for clinically relevant outcomes at each disease stage.

Main Methods:

• The study is based on discussions from the Alzheimer's Association Research Roundtable (AARR) meeting on November 19-20, 2019.
• Involved a review of current approaches from patients, care partners, clinicians, regulators, health economists, and policymakers.

Main Results:

• No universal agreement exists on what constitutes a clinically meaningful outcome or treatment effect in Alzheimer's disease.
• Perspectives from diverse stakeholders highlight the complexity in defining meaningfulness across the AD continuum.

Conclusions:

• Establishing a consensus on clinical meaningfulness is vital for advancing Alzheimer's disease research and treatment.
• Future efforts should focus on integrating patient and stakeholder perspectives to guide the development of meaningful therapeutic goals.