Transforming Neurodegeneration Trials: Strategic Decisions in Clinical Development Planning Involving Biomarkers and Precision Medicine

Clinical trials for neurodegenerative diseases (NDDs) face challenges due to patient variability in symptoms and progression, requiring therapies that effectively cross the blood-brain barrier and target specific areas. Biomarkers, such as fluid, digital, and imaging-based, help create enrichment strategies to stratify patients, enable early diagnosis, and predict treatment responses. Despite the utility, successfully employing these methods requires careful planning and a deep understanding of the field.