Evidence map›Paper›PMID 36933140›Full record

ArticleNeurology and therapy2023

Clinical and Scientific Challenges to Effectiveness Studies Under Coverage with Evidence Development in Alzheimer's Disease.

Peter J Morin, Quanwu Zhang, Weiming Xia, Donald Miller, Henry Querfurth, Amir Abbas Tahami Monfared

Open access · goldAbstract read
In one paragraph

Article in Neurology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 18% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
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

6 authors at 5 institutions in 3 countries.

Peter J MorinDepartment of Neurology, Boston University School of Medicine, Boston, MA, USA.
Quanwu ZhangGlobal Alzheimer's Disease and Brain Health, Eisai Inc., Nutley, NJ, USA.
Weiming XiaDepartment of Biological Science, Kennedy College of Sciences, University of Massachusetts Lowell, Lowell, MA, USA.
Donald MillerDepartment of Biological Science, Kennedy College of Sciences, University of Massachusetts Lowell, Lowell, MA, USA.
Henry QuerfurthDepartment of Neurology, Tufts Medical Center, Boston, MA, USA.
Amir Abbas Tahami MonfaredGlobal Alzheimer's Disease and Brain Health, Eisai Inc., Nutley, NJ, USA. amir_tahami@eisai.com.ORCID http://orcid.org/0000-0003-4003-3192
Boston University · USEisai (United States) · USMcGill University Health Centre · CATufts Medical Center · USUniversity of Massachusetts Lowell · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Centers for Medicare and Medicaid Services (CMS) has recently issued a national coverage determination for US Food and Drug Administration (FDA)-approved anti-amyloid monoclonal antibodies (mAbs) for the treatment of Alzheimer's disease (AD) under coverage with evidence development (CED). CED schemes are complex, costly, and challenging, and often fail to achieve intended objectives because of administrative and implementation issues. AD is a heterogeneous, progressive neurodegenerative disorder with complex care pathway that additionally presents scientific challenges related to the choice of study design and methods used in evaluating CED schemes. These challenges are herein discussed. Clinical findings from the US Veterans Affairs healthcare system help inform our discussion of specific challenges to CED-required effectiveness studies in AD.

Indexed as

Alzheimer’s diseaseAnti-amyloid monoclonal antibodiesCenters for Medicare & Medicaid ServicesCoverage with evidence developmentDisease-modifying treatmentMild cognitive impairmentNational coverage determination

Identifiers

PMID36933140
PMCPMC10195925
OpenAlexW4327811413

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.