Core Insights - The aging population in China is leading to an increased threat from Alzheimer's disease (AD), which has become the fifth leading cause of death in the country, following cardiovascular diseases, malignant tumors, chronic respiratory diseases, and diabetes [1] - There is a significant disease burden from Alzheimer's and other dementias in China, exceeding the global average, necessitating effective intervention measures to help patients capture the early intervention window [1] - Eli Lilly's TRAILBLAZER-ALZ2 long-term extension study results indicate that treatment with donanemab significantly slows disease progression, with benefits increasing over three years [1][2] Company Insights - Eli Lilly's TRAILBLAZER-ALZ2 study is a double-blind extension phase aimed at evaluating the long-term efficacy and safety of donanemab in early symptomatic Alzheimer's patients [2] - Participants originally receiving donanemab either continued treatment or switched to a placebo, while the placebo group began receiving donanemab under blind conditions [2] - The study included an external control group from the Alzheimer's Disease Neuroimaging Initiative (ADNI) to measure treatment outcomes [2] Study Results - Key preliminary results from the TRAILBLAZER-ALZ2 study show that participants receiving donanemab experienced sustained clinical benefits over three years, with a 0.6-point reduction in cognitive decline at 18 months and a 1.2-point reduction at 36 months on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) [3] - Early use of donanemab reduced the risk of disease progression to the next stage by 27% compared to delayed treatment [3] - Over 75% of participants treated with donanemab achieved amyloid clearance within 76 weeks, and the rate of amyloid plaque re-deposition remained slow at approximately 2.4 CL/year over a maximum observation period of 2.5 years [3] - No new safety signals were observed during the long-term extension phase, confirming the existing safety profile of donanemab [3]
多奈单抗注射液三年长期临床研究结果公布 创新疗法支持尽早干预