Evidence map›Paper›PMID 38706421›Full record

ArticleAlzheimer's & dementia : the journal of the Alzheimer's Association2024

Generating real-world evidence in Alzheimer's disease: Considerations for establishing a core dataset.

James E Galvin, Jeffrey L Cummings, Mihaela Levitchi Benea, Carl de Moor, Ricardo F Allegri, Alireza Atri, Howard Chertkow, Claire Paquet, Verna R Porter, Craig W Ritchie and 4 more

Abstract read
In one paragraph

Article in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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.

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

17 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Usage and positivity rates of Alzheimer's disease biomarkers in a memory clinic.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  5. Review
  6. Observational
  7. Article
  8. Article
  9. Article
  10. Everyday functioning in young onset dementia: differences between diagnostic groups.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  11. Real-world brain imaging in a population-based cohort enables accurate markers for dementia.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025
    Article
  12. Donanemab: Appropriate use recommendations.The journal of prevention of Alzheimer's disease · 2025
    Article
  13. Article
  14. Brain sciences · 2024
    Article
  15. Generating real-world evidence in Alzheimer's disease: Considerations for establishing a core dataset.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Article
  16. Article
  17. 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

14 authors.

James E GalvinComprehensive Center for Brain Health, Department of Neurology, University of Miami Miller School of Medicine, Boca Raton, Florida, USA.
Jeffrey L CummingsChambers-Grundy Center for Transformative Neuroscience, Department of Brain Health, University of Nevada Las Vegas (UNLV), Las Vegas, Nevada, USA.
Mihaela Levitchi BeneaFulcrum Therapeutics, Cambridge, Massachusetts, USA.
Carl de MoorBiogen, Cambridge, Massachusetts, USA.
Ricardo F AllegriInstituto de Investigaciones Neurológicas Fleni, Buenos Aires, Argentina.
Alireza AtriBanner Sun Health Research Institute, Sun City, Arizona, USA.
Howard ChertkowRotman Research Institute, Baycrest Health Sciences, Toronto, Ontario, Canada.
Claire PaquetUniversité de Paris GHU AP-HP Nord Lariboisière Hospital, Paris, France.
Verna R PorterPacific Brain Health Center, Pacific Neuroscience Institute, Santa Monica, California, USA.
Craig W RitchieScottish Brain Sciences, Edinburgh, UK.
Sietske A M SikkesAlzheimer Center Amsterdam, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Michael R SmithBiogen, Cambridge, Massachusetts, USA.
Christina Marsica GrassiBiogen, Cambridge, Massachusetts, USA.
Ivana RubinoBiogen, Cambridge, Massachusetts, USA.

Funding

Research Education ComponentP30AG072980 · NIA · BANNER HEALTH · PI ALIREZA ATRI · 2021 to 2026
$24.9M
Renewal of Centers of Biomedical Research Excellence (COBRE) (Phase 2) CNTN - ResubmissionP20GM109025 · NIGMS · CLEVELAND CLINIC FOUNDATION · PI JESSICA KIRKLAND CALDWELL · 2015 to 2026
$22.8M
Alzheimer's Clinical Trial InnOvatioN (ACTION) InitiativeR35AG071476 · NIA · UNIVERSITY OF NEVADA LAS VEGAS · PI CUMMINGS, JEFFREY L. · 2021 to 2025
$2.9M
Alzheimer's Disease and Related Dementias Innovation Incubator (InnovaTor)R25AG083721 · NIA · UNIVERSITY OF NEVADA LAS VEGAS · PI JEFFREY L. CUMMINGS, Xue K Zhong · 2023 to 2026
$1.0M
BiogenNIA NIH HHS P30 AG072980NIA NIH HHS R25 AG083721NIA NIH HHS R35 AG071476NIGMS NIH HHS P20 GM109025
6 · The paper itself

Abstract

Ongoing assessment of patients with Alzheimer's disease (AD) in postapproval studies is important for mapping disease progression and evaluating real-world treatment effectiveness and safety. However, interpreting outcomes in the real world is challenging owing to variation in data collected across centers and specialties and greater heterogeneity of patients compared with trial participants. Here, we share considerations for observational postapproval studies designed to collect harmonized longitudinal data from individuals with mild cognitive impairment or mild dementia stage of disease who receive therapies targeting the underlying pathological processes of AD in routine practice. This paper considers key study design parameters, including proposed aims and objectives, study populations, approaches to data collection, and measures of cognition, functional abilities, neuropsychiatric status, quality of life, health economics, safety, and drug utilization. Postapproval studies that capture these considerations will be important to provide standardized data on AD treatment effectiveness and safety in real-world settings.

Indexed as

Alzheimer DiseaseCognitive DysfunctionDisease ProgressionHumansObservational Studies as TopicQuality of LifeResearch DesignAlzheimer's diseasecore outcomesdata collectionpopulationreal‐world evidencestudy aims

Identifiers

PMID38706421
PMCPMC11180865

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.