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Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change estimates

INTRODUCTION: The Integrated Alzheimer's Disease Rating Scale (iADRS) has been used to detect differences in disease progression in early Alzheimer's disease (AD). The objectives of this study were to enhance understanding of iADRS point changes within the context of clinical trials, and t...

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Autores principales: Wessels, Alette M., Rentz, Dorene M., Case, Michael, Lauzon, Steve, Sims, John R.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9169866/
https://www.ncbi.nlm.nih.gov/pubmed/35676941
http://dx.doi.org/10.1002/trc2.12312
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author Wessels, Alette M.
Rentz, Dorene M.
Case, Michael
Lauzon, Steve
Sims, John R.
author_facet Wessels, Alette M.
Rentz, Dorene M.
Case, Michael
Lauzon, Steve
Sims, John R.
author_sort Wessels, Alette M.
collection PubMed
description INTRODUCTION: The Integrated Alzheimer's Disease Rating Scale (iADRS) has been used to detect differences in disease progression in early Alzheimer's disease (AD). The objectives of this study were to enhance understanding of iADRS point changes within the context of clinical trials, and to establish a minimal clinically important difference (MCID) on the iADRS. METHODS: Data from AMARANTH and EXPEDITION3 were analyzed using various approaches, including anchor‐based, distribution‐based, regression analyses, and cumulative distribution function (CDF) plots. Three potential anchors were examined, including the Clinical Dementia Rating—Sum of Boxes, Mini‐Mental State Examination, and Functional Activities Questionnaire. Triangulation of all results was used to determine the MCID for participants with mild cognitive impairment (MCI) due to AD and AD with mild dementia. RESULTS: All three anchors met criteria for “sufficiently associated” (|r| = 0.4–0.7). Cumulatively, results from anchor‐based and distribution‐based results converged to suggest an iADRS MCID of 5 points for MCI due to AD and 9 points for AD with mild dementia. Regression analyses and CDF plots supported these values. DISCUSSION: These findings suggest the iADRS can be used in clinical trials to detect a clinically meaningful outcome of AD progression.
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spelling pubmed-91698662022-06-07 Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change estimates Wessels, Alette M. Rentz, Dorene M. Case, Michael Lauzon, Steve Sims, John R. Alzheimers Dement (N Y) Research Articles INTRODUCTION: The Integrated Alzheimer's Disease Rating Scale (iADRS) has been used to detect differences in disease progression in early Alzheimer's disease (AD). The objectives of this study were to enhance understanding of iADRS point changes within the context of clinical trials, and to establish a minimal clinically important difference (MCID) on the iADRS. METHODS: Data from AMARANTH and EXPEDITION3 were analyzed using various approaches, including anchor‐based, distribution‐based, regression analyses, and cumulative distribution function (CDF) plots. Three potential anchors were examined, including the Clinical Dementia Rating—Sum of Boxes, Mini‐Mental State Examination, and Functional Activities Questionnaire. Triangulation of all results was used to determine the MCID for participants with mild cognitive impairment (MCI) due to AD and AD with mild dementia. RESULTS: All three anchors met criteria for “sufficiently associated” (|r| = 0.4–0.7). Cumulatively, results from anchor‐based and distribution‐based results converged to suggest an iADRS MCID of 5 points for MCI due to AD and 9 points for AD with mild dementia. Regression analyses and CDF plots supported these values. DISCUSSION: These findings suggest the iADRS can be used in clinical trials to detect a clinically meaningful outcome of AD progression. John Wiley and Sons Inc. 2022-06-06 /pmc/articles/PMC9169866/ /pubmed/35676941 http://dx.doi.org/10.1002/trc2.12312 Text en © 2022 Eli Lilly and Company. Alzheimer's & Dementia: Translational Research & Clinical Interventions published by Wiley Periodicals LLC on behlaf of Alzheimer's Association. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Research Articles
Wessels, Alette M.
Rentz, Dorene M.
Case, Michael
Lauzon, Steve
Sims, John R.
Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change estimates
title Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change estimates
title_full Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change estimates
title_fullStr Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change estimates
title_full_unstemmed Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change estimates
title_short Integrated Alzheimer's Disease Rating Scale: Clinically meaningful change estimates
title_sort integrated alzheimer's disease rating scale: clinically meaningful change estimates
topic Research Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9169866/
https://www.ncbi.nlm.nih.gov/pubmed/35676941
http://dx.doi.org/10.1002/trc2.12312
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