@article{43a03fa044fd47c090c1e2643fc2374b,
title = "Building clinically relevant outcomes across the Alzheimer's disease spectrum",
abstract = "Demonstrating that treatments are clinically meaningful across the Alzheimer's disease (AD) continuum is critical for meeting our goals of accelerating a cure by 2025. While this topic has been a focus of several Alzheimer's Association Research Roundtable (AARR) meetings, there remains no consensus as to what constitutes a “clinically meaningful outcome” in the eyes of patients, clinicians, care partners, policymakers, payers, and regulatory bodies. Furthermore, the field has not come to agreement as to what constitutes a clinically meaningful treatment effect at each stage of disease severity. The AARR meeting on November 19–20, 2019, reviewed current approaches to defining clinical meaningfulness from various perspectives including those of patients and care partners, clinicians, regulators, health economists, and public policymakers. Participants discussed approaches that may confer clinical relevance at each stage of the disease continuum and fostered discussion about what should guide us in the future.",
keywords = "Alzheimer's disease, clinical meaningfulness, cognitive decline, dementia, Research Roundtable, treatment",
author = "Rentz, {Dorene M.} and Wessels, {Alette M.} and Annapragada, {Ananth V.} and Berger, {Anna Karin} and Edgar, {Chris J.} and Michael Gold and Miller, {David S.} and Christopher Randolph and Ryan, {J. Michael} and Glen Wunderlich and Zoschg, {Megan Canniere} and Dominic Tr{\'e}pel and Knopman, {David S.} and Staffaroni, {Adam M.} and Bain, {Lisa J.} and Carrillo, {Maria C.} and Weber, {Christopher J.}",
note = "Funding Information: AMS receives funding from the NIH/NIA (K23 AG061253) and the Larry L. Hillblom Foundation (2018‐A‐025‐FEL) Funding Information: AW is a full‐time employee and shareholder of Eli Lilly and Company. AA declares stock ownership and consulting fees from Alzeca Inc, stock ownership in Sensulin LLC. CJE is a full‐time employee of Cogstate Ltd. MG is a full‐time employee of Abbvie, Inc. DSM is a full‐time employee of Signant Health. CR is a full‐time employee of MedAvante‐ProPhase. JMR, previously with Rodin Therapeutics, at time of publication is a full‐time employee of Carnot Pharma, LLC dba RA Ventures. GW is a full‐time employee of Boehringer Ingelheim. DSK served on a Data Safety Monitoring Board for the DIAN study. He serves on a Data Safety monitoring Board for a tau therapeutic for Biogen, but receives no personal compensation. He is an investigator in clinical trials sponsored by Biogen, Lilly Pharmaceuticals, and the University of Southern California. He serves as a consultant for Samus Therapeutics, Third Rock, Roche, and Alzeca Biosciences but receives no personal compensation. He receives research support from the NIH. AMS receives support from the NIH/NIA, the Larry L. Hillblom Foundation, and the Bluefield Project to Cure FTD. MCC, CW are full‐time employees of the Alzheimer's Association. Funding Information: InformationAMS receives funding from the NIH/NIA (K23 AG061253) and the Larry L. Hillblom Foundation (2018-A-025-FEL)The authors thank our contributing speakers, panelists, and moderators: David Knopman, MD; Dan Gibbs, MD; Katie Brandt, MM; John Hsiao; Megan Canniere Zoschg, PharmD; Michelle Campbell, PhD; James Rollins, MD; Pei Jung Lin, PhD; Dominic Trepel, PhD; Eric Bastings; Caroline Petit-Turcotte; Ananth Annapragada, PhD; Eric Siemers, MD; Ira Shoulson, MD; Ralph Benedict, PhD; Adam Staffaroni, PhD; J. Michael Ryan, MD; Dorene Rentz, PsyD; Alette Wessels, PhD; Jessica Langbaum, PhD; Glenn Stebbins, PhD; Sonya Eremenco, MA; Kenneth Rockwood, MD; Fiona McDougall, PhD; Kate Papp, PhD; Sam Dickson, PhD; Michael Donohue, PhD. Publisher Copyright: {\textcopyright} 2021 the Alzheimer's Association",
year = "2021",
doi = "10.1002/trc2.12181",
language = "English (US)",
volume = "7",
journal = "Alzheimer's and Dementia: Translational Research and Clinical Interventions",
issn = "2352-8737",
publisher = "Elsevier Inc.",
number = "1",
}