Long-Term Real-World Study of Donanemab Plus Usual Care Compared to Usual Care Alone in US Patients with Early Alzheimers Disease

What this Trial Is About

Researchers are evaluating the long-term effectiveness of donanemab combined with usual care compared to usual care alone in people with early symptomatic Alzheimers disease. This observational study is designed to reflect real-world medical practice by using ongoing assessments and linking to past and future electronic health records. The study will last about 273 weeks and may involve up to 28 visits. Participants will either receive open-label donanemab administered intravenously along with usual care, or they will receive usual care alone, which may include medications excluding amyloid-targeting agents or non-drug therapies like watchful waiting. The study groups are observed prospectively without blinding. During the study, participants will be monitored regularly through various assessments including the Dependence Scale, Functional Assessment Questionnaire, and Neuropsychiatric Inventory, among others, up to five years. Researchers will track changes in cognition, independence, living situation, and caregiver burden. Electronic health records will be accessed throughout, and safety and outcome data will be collected over the long term.

A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease