Aducanumab for Alzheimer's disease: Observations and opportunities.

Abstract

Objective: To analyse the overseas approval of aducanumab for Alzheimer's disease, in order to derive lessons of potential interest to individuals and groups involved in dementia drug development and regulation in Australia.

Conclusions: Opportunities were identified regarding optimising clinical trial design and solidifying regulatory responsibilities. Increased awareness of the attitudes and needs of patients and patient advocacy organisations would likely improve the patient-clinician alliance. Incorporation of these factors into research design has the potential to improve patient satisfaction with outcomes.