Defining benefit: Clinically and biologically meaningful outcomes in the next‐generation Alzheimer's disease clinical care pathway Article Swipe
Aya Elhage
,
Sharon Cohen
,
Jeffrey L. Cummings
,
Wiesje M. van der Flier
,
Paul Aisen
,
Min Cho
,
Joanne Bell
,
Harald Hampel
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1002/alz.14425
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1002/alz.14425
To understand the potential benefits of emerging Alzheimer's disease (AD) therapies within and beyond clinical trial settings, there is a need to advance current outcome measurements into meaningful information relevant to all stakeholders. The relationship between the impact on disease biology and clinically measurable outcomes in cognition, function, and behavior must be considered when defining the meaningful benefit of early AD therapies. In this review, we discuss: (1) the lack of consideration for biomarkers in the current concept of meaningfulness in AD; (2) the lack of gold standards for determining minimal biologically and clinically important differences (MBCIDs) in AD trials; (3) how the treatment benefits of disease‐modifying treatments are cumulative and increase over time; and (4) the different concepts of meaningfulness among key stakeholders. This review utilizes the future clinical biological framework of AD and aims to further integrate and expand the parameters of meaningful benefits toward a precision medicine framework. Highlights Definition of meaningful benefit from Alzheimer's disease (AD) treatment varies across disease stage and stakeholder perspectives. Observable and meaningful outcomes must consider the clinical‐biological nature of AD. Statistically significant effects or outcomes do not always equate to clinically meaningfulness. Assessment tools must reflect stage‐specific subtle changes following treatment. Real‐world evidence will support consensus, definition, and interpretation of clinical meaningfulness.
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Metadata
- Type
- review
- Language
- en
- Landing Page
- https://doi.org/10.1002/alz.14425
- OA Status
- hybrid
- Cited By
- 8
- References
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- Related Works
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- OpenAlex ID
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All OpenAlex metadata
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https://openalex.org/W4405590182Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1002/alz.14425Digital Object Identifier
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Defining benefit: Clinically and biologically meaningful outcomes in the next‐generation Alzheimer's disease clinical care pathwayWork title
- Type
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reviewOpenAlex work type
- Language
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enPrimary language
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2024Year of publication
- Publication date
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2024-12-19Full publication date if available
- Authors
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Aya Elhage, Sharon Cohen, Jeffrey L. Cummings, Wiesje M. van der Flier, Paul Aisen, Min Cho, Joanne Bell, Harald HampelList of authors in order
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https://doi.org/10.1002/alz.14425Publisher landing page
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YesWhether a free full text is available
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hybridOpen access status per OpenAlex
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https://doi.org/10.1002/alz.14425Direct OA link when available
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Disease, Clinical trial, Psychology, Cognition, Stakeholder, Medicine, Intensive care medicine, Neuroscience, Pathology, Public relations, Political scienceTop concepts (fields/topics) attached by OpenAlex
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8Total citation count in OpenAlex
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2025: 8Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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