The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.
Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.
Trial participants who were dosed with donanemab in the main study will be enrolled to a 3-year follow up addendum. No study drug will be administered during this follow up.
Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain amyloid and tau pathology.
Following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. Participants from the addendum safety cohort are not eligible for the extension period.
Participants previously dosed with donanemab in the main study will be monitored to track re-accumulation of amyloid plaque for 3 years.
