軽度アルツハイマー病患者を対象としたガンテネルマブの研究

基本情報

NCT ID

NCT02051608

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

389

治験依頼者名

Hoffmann-La Roche

概要

Part 1 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab in participants with mild Alzheimer disease. Participants will be randomized to receive either gantenerumab subcutaneously every 4 weeks or placebo subcutaneously every 4 weeks. Approved Alzheimer medication is allowed if on stable dose for 3 months prior to screening. Part 2 is an open-label extension (OLE). A positron emission tomography (PET) imaging substudy will be conducted within the main study. Eligible participants who provide separate informed consent will undergo PET imaging scans using the radioligand florbetapir as a pharmacodynamic measure of changes in brain amyloid load over time.

対象疾患

介入

依頼者（Sponsor）

実施施設 (11)