トレイルブレイザー-ALZ 2 ランダム化臨床試験

John R Sims¹, Jennifer A Zimmer¹, Cynthia D Evans¹

¹Eli Lilly and Company, Indianapolis, Indiana.

JAMA

|July 17, 2023

まとめ

アルツハイマー病の抗体治療であるドナネマブは,初期症状のある患者の疾患進行を著しく遅らせました. このアルツハイマー病の薬は,低/中等および結合タウ病理群の両方で有効性を示しました.

科学分野:

神経学
免疫療法
アルツハイマー病の研究

背景:

アルツハイマー病の有効な治療法は限られている.
ドーナネマブは,アルツハイマー病の特徴である脳内のアミロイドプラークを標的とし,除去します.

研究の目的:

初期症状のアルツハイマー病患者のドナネマブの有効性と安全性を評価する.
認知機能低下に対するドナネマブの影響を評価する.

主な方法:

3期多中心ランダム化ダブルブラインドプラセボ対照試験
初期症状のアルツハイマー病患者の1736人は,ドナネマブまたはプラセボを静脈内投与して72週間投与された.
主要結果:統合アルツハイマー病評価スケール (iADRS) の変化76週間.

主要な成果:

ドーナネマブは,低/ 中程度のタウと組み合わせたタウ病理群の両方で,臨床進行を著しく遅らせました.
統計的に有意な結果は24のゲートアウトカムのうち23で観察されました.
アミロイド関連画像異常 (ARIA) は,ドナネマブ群の24. 0%で,プラセボ群の2. 1%で発生した.

結論:

ドーナネマブは早期症状性アルツハイマー病の有望な治療法です.
この薬は,特に特定のタウ病理プロファイルを持つ患者に,臨床進行を著しく遅らせました.
ARIAのさらなる研究とモニタリングが必要である.

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