Abstract Body

It has been over 25 years since the first symptomatic treatment for Alzheimer’s disease was approved by the US Food and Drug Administration (FDA) in 1993. Since then, the Alzheimer’s disease research community has made tremendous strides, learning much about biomarkers underlying disease pathophysiology, improving the design of clinical trials, and increasing the diversity of potential therapeutic targets. Emerging positive clinical trial data from several new anti-amyloid beta (Aβ) monoclonal antibodies (mAbs) has given new hope to physicians and patients. Most recently, the FDA’s approval of aducanumab, a human IgG1 mAb that targets Aβ aggregates, via the accelerated approval pathway has ushered in a new era and, for the first time, patients will be treated with a therapy that targets the underlying pathophysiology of the disease. Clinical trial data and real-world evidence generated from ongoing trials of aducanumab will inform key clinical questions such as the optimal duration of treatment and the ideal biomarker profile for benefit, at initiation and as the disease progresses. In addition to these developments, innovations in biomarkers and diagnostics have evolved our collective understanding of how Alzheimer’s disease may be detected, monitored and managed. Together, these advances will help to answer questions about the long-term outcomes of treatment and the impact of delayed progression on the lives of patients, caregivers, and society. Most importantly, these data will also contribute to the generation of new hypotheses for future research that will continue to move the field forward.