Jeffrey Cummings, Sharon Cohen, Jennifer Murphy, Holly M. Brothers, Mina Nejati, Fiona Forrestal, Carl de Moor, John O'Gorman, John Harrison, Judith Jaeger, Catherine Jane Mummery, Anton P. Porsteinsson, Michele Potashman, Ying Tian, Lili Yang, Ping He, Samantha Budd Haeberlein
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引用次数: 0
Abstract
INTRODUCTION
In EMERGE (NCT02484547), participants receiving aducanumab had significantly less progression versus placebo on all prespecified clinical endpoints at week 78. Here, we explicate the clinical meaningfulness of these treatment effects by analyzing item-level data and the persistence of treatment benefit.
METHODS
Participants with early Alzheimer's disease (AD) were stratified by apolipoprotein E (APOE) ε4 status and randomized (1:1:1) to receive low- or high-dose aducanumab, or placebo. Prespecified principal component analyses (PCAs) per the Statistical Analysis Plan were followed by post hoc examination of individual domains/items across all five clinical endpoints. Progression analysis assessed reduction in clinical decline.
RESULTS
High-dose aducanumab demonstrated clinically meaningful slowing of progression across clinical endpoints measuring cognition, daily function, and behavioral symptoms. Delay of progression over 18 months was consistent across measures; treatment effects increased over time.
DISCUSSION
Across multiple analyses aducanumab slowed cognitive decline, prolonged functional independence, and attenuated behavioral symptoms in participants with early AD. These outcomes comprise the elements of a clinically meaningful response to treatment.
Highlights
Endpoints in EMERGE assessed different aspects of cognition, daily function, and behavioral symptoms.
Treatment benefits were observed across subdomains on all five clinical endpoints.
Aducanumab meaningfully slowed disease progression in participants with early AD.
期刊介绍：
Alzheimer's & Dementia is a peer-reviewed journal that aims to bridge knowledge gaps in dementia research by covering the entire spectrum, from basic science to clinical trials to social and behavioral investigations. It provides a platform for rapid communication of new findings and ideas, optimal translation of research into practical applications, increasing knowledge across diverse disciplines for early detection, diagnosis, and intervention, and identifying promising new research directions. In July 2008, Alzheimer's & Dementia was accepted for indexing by MEDLINE, recognizing its scientific merit and contribution to Alzheimer's research.
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