早期アルツハイマー病（AD）患者を対象としたガンテネルマブの安全性および有効性に関する研究

基本情報

NCT ID

NCT03443973

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

975

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 gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 116. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.

対象疾患

介入

依頼者（Sponsor）

実施施設 (16)