Anticipating Trial Design Challenges Across the Alzheimer’s Disease Severity Continuum

Alzheimer’s disease (AD) exists across a vast continuum of disease severity, from early biological changes in the brain that may go completely unnoticed to the debilitating functional decline experienced by mid to late-stage dementia patients. With such a wide range of symptomology, clinical trial teams must approach different stages of AD almost like different diseases, aligning endpoints and trial design to match the disease stage and related patient and caregiver experiences.

In this whitepaper, we will examine trial design challenges across the AD severity continuum. We will explore how careful endpoint selection, targeted rater training, and strategic electronic clinical outcome assessment (eCOA) implementation can address the unique demands of each disease stage. With a thoughtful participant and rater-centric trial design, sponsors can capture the high-quality data needed to make drug development decisions and bring new treatments to market, all while supporting patients and caregivers as they navigate this debilitating disease.

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