前駆期から軽度アルツハイマー病（AD）患者を対象とした、クレネズマブとプラセボの有効性および安全性を評価する研究。

基本情報

NCT ID

NCT02670083

ステータス

中止

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

813

治験依頼者名

Hoffmann-La Roche

概要

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

対象疾患

介入

依頼者（Sponsor）

実施施設 (10)