TY - JOUR
T1 - Evaluation of clinical benefits of treatments for Alzheimer's disease
AU - Liu, Kathy Y.
AU - Walsh, Sebastian
AU - Brayne, Carol
AU - Merrick, Richard
AU - Richard, Edo
AU - Howard, Robert
N1 - Funding Information: KYL is supported by the UK Medical Research Council (MR/S021418/1). SW is funded by a National Institute for Health and Care Research Doctoral Fellowship. RM is funded by Alzheimer's Research UK (doctoral studentship ARUK-PhD2017–34). RH is supported by the University College London Hospitals NHS Foundation Trust National Institute for Health Research Biomedical Research Centre. The authors' funding sources were not involved in the writing of the manuscript or the decision to submit it for publication. Publisher Copyright: © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license
PY - 2023/11/1
Y1 - 2023/11/1
N2 - The need for regulatory approval of new therapies for the treatment of Alzheimer's disease—a progressive neurodegenerative condition—has made the assessment of treatment efficacy an urgent priority for discussion and investigation in the field. In the first part of this Personal View, we summarise current views on what constitutes a clinically meaningful benefit from treatment for Alzheimer's disease, including the concept of a minimum treatment effect against which to compare trial outcomes and its limitations. Considering existing and divergent definitions of clinically meaningful change, we define this concept in the second part of the Personal View by proposing a new approach that consecutively considers whether a treatment benefit for Alzheimer's disease is noticeable, valuable, and worthwhile in the context of costs and risks. This approach could be a useful foundation from which the field can move forwards on this issue and address existing gaps in understanding.
AB - The need for regulatory approval of new therapies for the treatment of Alzheimer's disease—a progressive neurodegenerative condition—has made the assessment of treatment efficacy an urgent priority for discussion and investigation in the field. In the first part of this Personal View, we summarise current views on what constitutes a clinically meaningful benefit from treatment for Alzheimer's disease, including the concept of a minimum treatment effect against which to compare trial outcomes and its limitations. Considering existing and divergent definitions of clinically meaningful change, we define this concept in the second part of the Personal View by proposing a new approach that consecutively considers whether a treatment benefit for Alzheimer's disease is noticeable, valuable, and worthwhile in the context of costs and risks. This approach could be a useful foundation from which the field can move forwards on this issue and address existing gaps in understanding.
UR - http://www.scopus.com/inward/record.url?scp=85175417110&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/S2666-7568(23)00193-9
DO - https://doi.org/10.1016/S2666-7568(23)00193-9
M3 - Review article
C2 - 37924845
SN - 2666-7568
VL - 4
SP - e645-e651
JO - The Lancet Healthy Longevity
JF - The Lancet Healthy Longevity
IS - 11
ER -