回复

多奈单抗对晚期阿尔茨海默病患者的安全性和有效性尚未确定。

多奈单抗可减缓阿尔茨海默病 (AD) 的疾病进展。 患有以下疾病的患者应开始使用多奈单抗治疗

• AD神经病理学证据，以及
• 轻度认知障碍 (MCI) 或疾病的轻度痴呆阶段。¹

与临床试验中的研究相比，在 更晚期AD阶段开始多奈单抗治疗的安全性和有效性尚未得到评估或确定。¹ 

已完成的2期研究以及已完成和正在进行的3期 多奈单抗 研究已入组或正在入组患有早期症状AD或临床前AD的患者。 这些研究将早期症状性AD定义为

• 前驱期AD，即 MCI 明显的AD症状阶段，或
• 患有轻度痴呆的AD，其症状严重到足以满足痴呆的诊断标准。^2-8

上次审阅日期：2023年8月22日

参考文献

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Mintun MA, Lo AC, Evans CD, et al. Donanemab in early Alzheimer’s disease. N Engl J Med. 2021;384(18):1691-1704. https://doi.org/10.1056/NEJMoa2100708

3. A follow-on study of donanemab (LY3002813) with video assessments in participants with Alzheimer's disease (TRAILBLAZER-EXT). ClinicalTrials.gov. May 26, 2022. Accessed July 19, 2022. https://clinicaltrials.gov/ct2/show/NCT04640077

4. Sims JR, Zimmer JA, Evans CD, et al; TRAILBLAZER-ALZ 2 Investigators. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512-527. https://doi.org/10.1001/jama.2023.13239

5. Tariot PN, Reiman EM, Alexander RC, et al. TRAILBLAZER-ALZ 3 trial design and rationale. J Prev Alzheimers Dis. 2021;8(suppl 1):S3. 14th Annual Clinical Trials on Alzheimer's Disease Conference abstract S3. http://dx.doi.org/10.14283/jpad.2021.57

6. A study of donanemab (LY3002813) compared with aducanumab in participants with early symptomatic Alzheimer's disease (TRAILBLAZER-ALZ 4). ClinicalTrials.gov identifier NCT05108922. Updated July 20, 2023. Accessed October 9, 2023. https://clinicaltrials.gov/ct2/show/NCT05108922

7. A study of donanemab (LY3002813) in participants with early symptomatic Alzheimer's disease (TRAILBLAZER-ALZ 5). ClinicalTrials.gov. February 21, 2023. Accessed February 24, 2023. https://www.clinicaltrials.gov/ct2/show/NCT05508789

8. A study of different donanemab (LY3002813) dosing regimens in adults with early Alzheimer's disease (TRAILBLAZER-ALZ 6). ClinicalTrials.gov. June 12, 2023. Accessed June 19, 2023. https://clinicaltrials.gov/ct2/show/NCT05738486