Evidence map›Paper›PMID 42552749›Full record

ReviewAlzheimer's & dementia : the journal of the Alzheimer's Association2026

Further data to address the Alzheimer's coverage with evidence development questions.

Malaz Boustani, Eric G Klein, Jennifer A Zimmer, Hong Wang, Staci E Engle, Adam Phipps, Maureen Japha, Traci Schilling, Ann Hartry, Alzheimer's Disease Neuroimaging Initiative

3 registry-linked trialsAbstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03887455 phase3active not recruitingnot on this map

A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

TypeinterventionalSponsorEisai Inc.Ran2019 to 2029Enrolled1,906ConditionsEarly Alzheimer's DiseaseArmsLecanemab IV, Placebo, Lecanemab SC
NCT04437511 phase3active not recruitingnot on this map

Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

TypeinterventionalSponsorEli Lilly and CompanyRan2020 to 2028Enrolled1,736ConditionsAlzheimer DiseaseArmsDonanemab, Placebo
NCT05738486 phase3active not recruitingnot on this map

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

TypeinterventionalSponsorEli Lilly and CompanyRan2023 to 2027Enrolled1,175ConditionsAlzheimer's Disease, Dementia, Brain Diseases, Central Nervous System DiseasesArmsDonanemab, Placebo, Dexamethasone
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Malaz BoustaniIndiana University School of Medicine, Indianapolis, Indiana, USA.
Eric G KleinEli Lilly and Company, Indianapolis, Indiana, USA.
Jennifer A ZimmerEli Lilly and Company, Indianapolis, Indiana, USA.
Hong WangEli Lilly and Company, Indianapolis, Indiana, USA.
Staci E EngleEli Lilly and Company, Indianapolis, Indiana, USA.
Adam PhippsEli Lilly and Company, Indianapolis, Indiana, USA.
Maureen JaphaEli Lilly and Company, Indianapolis, Indiana, USA.
Traci SchillingEli Lilly and Company, Indianapolis, Indiana, USA.
Ann HartryEli Lilly and Company, Indianapolis, Indiana, USA.
Alzheimer's Disease Neuroimaging Initiative

Funding

Project 1U19AG024904 · NIA · NORTHERN CALIFORNIA INSTITUTE/RES/EDU · PI MONICA G. RIVERA-MINDT · 2016 to 2026
$226.7M
Eli Lilly and CompanyNIA NIH HHS U19 AG024904
6 · The paper itself

Abstract

introductionMedicare 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.

methodsUpdate the previously published review responding to the CED questions by summarizing recently published donanemab and lecanemab extension data and new safety-related data.

resultsNew 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 registrationNCT04437511, NCT05738486, NCT03887455.

Indexed as

Alzheimer DiseaseAntibodies, Monoclonal, HumanizedMedicareHumansUnited StatesAntibodies, Monoclonal, HumanizedAlzheimer diseaseamyloid‐related imaging abnormalitiesamyloid‐targeting therapyanti‐amyloid monoclonal antibodyCenters for Medicare and Medicaid Servicescerebral edemacognitive and functional declinecoverage with evidence developmentdementiaDonanemabearly symptomatic Alzheimer's diseasehealth outcomesMedicaremild cognitive impairmentNational Coverage Determination

Identifiers

PMID42552749
PMCPMC13438179

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.