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达雷妥尤单抗皮下注射治疗轻度至中度阿尔茨海默病的开放标签、试点研究。

An Open-Label, Pilot Study of Daratumumab SC in Mild to Moderate Alzheimer's Disease.

作者信息

Gordon Marc L, Christen Erica, Keehlisen Lynda, Gong Michelle, Lam Fung, Giliberto Luca, Gomar Jesus J, Koppel Jeremy

机构信息

Northwell, NY, USA.

Litwin-Zucker Research Center, Feinstein Institutes for Medical Research, Manhasset, NY, USA.

出版信息

J Alzheimers Dis Rep. 2024 Jul 31;8(1):1111-1114. doi: 10.3233/ADR-240089. eCollection 2024.

DOI:10.3233/ADR-240089
PMID:39114556
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11305838/
Abstract

We conducted a small, open-label, pilot study of daratumumab to explore target engagement, safety, and potential efficacy in patients with mild to moderate Alzheimer's disease. Daratumumab SC 1800 mg was given subcutaneously weekly for 8 weeks, then every 2 weeks for 16 weeks. Flow cytometry to measure the CD38+ proportion of CD8 + CD4- T cells and cognitive assessments were performed at baseline, day 176, and day 246. Daratumumab significantly reduced CD38 + CD8 + CD4- T cells after 24 weeks and this effect persisted 11 weeks thereafter. There was no hematological toxicity or unexpected adverse events. Responder analysis showed no improvement on cognitive outcome measures.

摘要

我们开展了一项小型、开放标签的达雷妥尤单抗试点研究，以探究其在轻度至中度阿尔茨海默病患者中的靶点结合情况、安全性和潜在疗效。皮下注射达雷妥尤单抗1800毫克，每周一次，共8周，然后每2周一次，共16周。在基线、第176天和第246天进行流式细胞术检测CD8⁺CD4⁻T细胞的CD38⁺比例以及认知评估。24周后，达雷妥尤单抗显著降低了CD38⁺CD8⁺CD4⁻T细胞水平，且该效果在之后的11周持续存在。未出现血液学毒性或意外不良事件。反应者分析显示认知结果指标无改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9ed/11305838/420acdea28ad/adr-8-adr240089-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9ed/11305838/420acdea28ad/adr-8-adr240089-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b9ed/11305838/420acdea28ad/adr-8-adr240089-g001.jpg

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