Additional Relevant Details
PRIME is the ongoing Phase 1b randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and clinical effects of aducanumab in patients with prodromal or mild AD.The placebo-controlled portion of the study included fixed doses of aducanumab at 1, 3, 6 and 10 mg/kg and a titration regimen. PRIME also has a long-term extension for patients who completed the one-year placebo-controlled portion of the study.In a recently completed interim analysis from PRIME, efficacy and safety data were consistent with results previously reported. These data support the design of the ongoing Phase 3 ENGAGE and EMERGE studies. Biogen plans to share detailed information about these results at upcoming medical meetings.