Related Experiment Video
Updated: Aug 6, 2026

Full- versus Sub-Regional Quantification of Amyloid-Beta Load on Mouse Brain Sections
Published on: May 19, 2022
Further data to address the Alzheimer's coverage with evidence development questions
Malaz Boustani1, Eric G Klein2, Jennifer A Zimmer2
1Indiana University School of Medicine, Indianapolis, Indiana, USA.
Introduction:
Medicare patients currently access amyloid-targeting therapies for Alzheimer's disease through the class-based National Coverage Determination (NCD) with coverage with evidence development (CED) established in 2022. Evidence addressing the stated CED questions was previously published in a 2024 review; however, the original 2022 NCD remains unchanged.
Methods:
Update the previously published review responding to the CED questions by summarizing recently published donanemab and lecanemab extension data and new safety-related data.
Results:
New evidence addresses each of the three CED questions. Extension data show that the benefit of amyloid-targeting therapy continues to accrue with no new safety signals observed. Safety analyses identified baseline risk factors for amyloid-related imaging abnormalities (ARIA). Further, a more gradual donanemab titration regimen decreased risk of ARIA-edema/effusions.
Discussion:
With CED questions addressed, reconsideration of the class-based NCD is scientifically justified.
Clinical Trial Registration:
NCT04437511, NCT05738486, NCT03887455.
Related Concept Videos
Alzheimer's Disease: Overview
The clinical diagnosis of AD hinges on the presence of memory and other cognitive impairments. Biomarkers, such as changes in Aβ and tau...
Alzheimer Disease l: Introduction
Alzheimer's Disease: Treatment
Dementia
The progression of dementia is generally gradual.
Alzheimer Disease ll: Pathophysiology
Dementia l: Introduction
