The landscape for Alzheimer’s disease diagnosis has changed significantly over the past decade, but there is still only one conditionally FDA-approved medication. Despite extensive research and many expensive clinical trials, more than 200 investigational programs have failed or been abandoned in the past 10 years alone. New treatments are needed to prevent Alzheimer’s, delay its onset, slow its progression, improve cognition, and reduce behavioral disturbances.
Important advances have been made in our understanding of the underlying pathology and ability to measure in vivo biomarkers to make possible early detection and confirmation of the disease. However, there remain several challenges in successfully bringing new disease-modifying treatments through the clinical development process.
Key Learning Objectives
- Historical and current trends in Alzheimer’s disease
- Main reasons for clinical trial failures
- Current scientific hypotheses and related therapeutic approaches
- When treatment should begin in relation to the underlying disease
- Study design options
- Identifying the right sites, patients, and study partners
- Patient retention and other keys to running long-term trials
- The role of adjudication committees