Clinical Meaningfulness of Donanemab in Early Symptomatic Alzheimer Disease
6 affiliations
- 1Banner Sun Health Research Institute and Banner Alzheimer's Institute, Banner Health, Sun City and Phoenix, AZ;
- 2Center for Brain/Mind Medicine, Department of Neurology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA;
- 3Department of Neurology, and Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN;
- 4Department of Radiology, Indiana University School of Medicine, Indianapolis, IN;
- 5Tokyo Metropolitan Institute for Geriatrics and Gerontology, Tokyo, Japan; and
- 6Eli Lilly and Company, Indianapolis, IN
Abstract
BACKGROUND AND OBJECTIVES: Understanding the meaningfulness of clinical trial outcomes is essential for people living with Alzheimer disease (AD) and their clinicians to make evidence-based shared treatment decisions in real-world clinical care. Donanemab, a monoclonal antibody targeting the insoluble form of β-amyloid found in plaques, significantly slows cognitive and functional decline of AD in participants with mild cognitive impairment (MCI) or mild AD-related dementia. This analysis reviews the efficacy of donanemab across various clinical outcome assessments, using both published data and new complementary analyses to provide context on its potential benefits for patients and caregivers. METHODS: ) and AD Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL); Clinical Dementia Rating (CDR)-Sum of Boxes (CDR-SB) for clinical severity and individual cognitive and functional domains; CDR-Global for clinical severity stage progression; meaningful within-patient change (MWPC); and ADCS-Activities of Daily Living dependence score. RESULTS: = 0.005). DISCUSSION: These results add to the evidence and further support clinically meaningful donanemab-mediated effects on cognition and function for patients and their caregivers and may aid communication of realistic treatment expectations and informed decision-making. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov NCT04437511. Submitted: June 17, 2020; First patient enrolled: June 19, 2020. clinicaltrials.gov/study/NCT04437511 EudraCT Number 2020-000077-25. Start date of recruitment: June 19, 2020. clinicaltrialsregister.eu/ctr-search/trial/2020-000077-25/results.
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BibTeX
@article{atri2026clinical,
title = {{Clinical Meaningfulness of Donanemab in Early Symptomatic Alzheimer Disease}},
author = {Alireza Atri and Liana G. Apostolova and Atsushi Iwata and Alette M. Wessels and Alexandra S. Atkins and Ming Lu and Wenyu Ye and Sinéad Ryan and Erin Gautier Doty},
journal = {Neurology Clinical Practice},
year = {2026},
month = may,
doi = {10.1212/cpj.0000000000200621},
url = {https://doi.org/10.1212/cpj.0000000000200621},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Clinical Meaningfulness of Donanemab in Early Symptomatic Alzheimer Disease
AU - Alireza Atri
AU - Liana G. Apostolova
AU - Atsushi Iwata
AU - Alette M. Wessels
AU - Alexandra S. Atkins
AU - Ming Lu
AU - Wenyu Ye
AU - Sinéad Ryan
AU - Erin Gautier Doty
PY - 2026
DA - 2026/05/14
JO - Neurology Clinical Practice
DO - 10.1212/cpj.0000000000200621
UR - https://doi.org/10.1212/cpj.0000000000200621
AB - BACKGROUND AND OBJECTIVES: Understanding the meaningfulness of clinical trial outcomes is essential for people living with Alzheimer disease (AD) and their clinicians to make evidence-based shared treatment decisions in real-world clinical care. Donanemab, a monoclonal antibody targeting the insoluble form of β-amyloid found in plaques, significantly slows cognitive and functional decline of AD in participants with mild cognitive impairment (MCI) or mild AD-related dementia. This analysis reviews the efficacy of donanemab across various clinical outcome assessments, using both published data and new complementary analyses to provide context on its potential benefits for patients and caregivers. METHODS: ) and AD Cooperative Study-Instrumental Activities of Daily Living (ADCS-iADL); Clinical Dementia Rating (CDR)-Sum of Boxes (CDR-SB) for clinical severity and individual cognitive and functional domains; CDR-Global for clinical severity stage progression; meaningful within-patient change (MWPC); and ADCS-Activities of Daily Living dependence score. RESULTS: = 0.005). DISCUSSION: These results add to the evidence and further support clinically meaningful donanemab-mediated effects on cognition and function for patients and their caregivers and may aid communication of realistic treatment expectations and informed decision-making. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov NCT04437511. Submitted: June 17, 2020; First patient enrolled: June 19, 2020. clinicaltrials.gov/study/NCT04437511 EudraCT Number 2020-000077-25. Start date of recruitment: June 19, 2020. clinicaltrialsregister.eu/ctr-search/trial/2020-000077-25/results.
SN - 2163-0402
SN - 2163-0933
ER -