Patient-Guided Clinical Research for Alzheimer's Disease

This article is a guide focused on building a program for patient-guided clinical research specifically for Alzheimer's disease. It outlines the importance of incorporating patient perspectives in trial designs due to the communication challenges faced by patients as the disease progresses. The discussion highlights the need for trials to consider the burden on participants, including the frequency of assessments and sample sizes, while still meeting regulatory requirements. It also documents various approaches to data collection, including less frequent efficacy assessments to ease patient participation. Additionally, the article presents methods like genomic and biomarker classification to tailor treatments to specific patient subtypes. Digital technologies are mentioned as tools that can facilitate remote monitoring of cognitive endpoints. Lastly, the guide discusses adaptive trial designs, showcasing examples of efficient methodologies that reduce participant stress while maintaining regulatory standards.