Cited by 18Dementia and Cognitive Impairment ResearchAlzheimer's disease research and treatmentsStatistical Methods in Clinical Trials

The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.

Reproducibility and replicability of high‐frequency, in‐home digital biomarkers in reducing sample sizes for clinical trials

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Wu, Chao‐Yi, Beattie, Zachary, Mattek, Nora, Sharma, Nicole, Kaye, Jeffrey, Dodge, Hiroko H.·2021·Alzheimer's & Dementia: Translational Research & Clinical Interventions

Abstract

Introduction: Reproducibility and replicability of results are rarely achieved for digital biomarkers analyses. We reproduced and replicated previously reported sample size estimates based on digital biomarker and neuropsychological test outcomes in a hypothetical 4‐year early‐phase Alzheimer's disease trial. Methods: Original data and newly collected data (using a different motion sensor) came from the Oregon Center for Aging & Technology (ORCATECH). Given trajectories of those with incident mild cognitive impairment and normal cognition would represent trajectories of the control and experimental groups in a hypothetical trial, sample sizes to provide 80% power to detect effect sizes ranging from 20% to 50% were calculated. Results: For the reproducibility, identical P ‐values and slope estimates were found with both digital biomarkers and neuropsychological test measures between the previous and current studies. As for the replicability, a greater correlation was found between original and replicated sample size estimates for digital biomarkers ( r = 0.87, P < .001) than neuropsychological test outcomes ( r = 0.75, P < .001). Discussion: Reproducibility and replicability of digital biomarker analyses are feasible and encouraged to establish the reliability of findings.

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  • Digital biomarkers used in clinical trials are capable of significantly reducing needed sample sizes.

    “digital biomarkers used in clinical trials that are capable of significantly reducing needed sample sizes. 39 , 40”

    From Developing digital health technologies for frontotemporal degeneration (2025) · cites this paper as [39]

    The Introduction (page unavailable) reports markedly lower projected sample sizes for specific in-home digital biomarkers compared with cognitive tests. The estimates concern hypothetical preclinical Alzheimer’s trials; the paper does not establish that digital biomarkers have reduced sample sizes in clinical trials generally. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

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Research works printed but not linked: 23

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Metadata

Authors
Wu, C., Beattie, Z., Mattek, N., Sharma, N., Kaye, J., & Dodge, H. H.
Affiliations
Oregon Health & Science University (US)
Corresponding author
Wu, Chao‐Yi
Venue
Alzheimer's & Dementia: Translational Research & Clinical Interventions
Publisher
Wiley
Published
2021-01
Volume
7
Issue
1
Pages
e12220-e12220
ISSN
2352-8737 (ISSN-L)
OpenAlex
W4205092819
Cited by
18
References
4
Citations by year
2026: 2 · 2025: 4 · 2024: 5 · 2023: 5 · 2022: 1 · 2021: 1
FWCI
2.15
Type
journal article
Language
en
Open access
Locations
  • Alzheimer s & Dementia Translational Research & Clinical Interventions (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Funders
National Center for Advancing Translational Sciences (UL1 TR002369)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
digital biomarkers, reproducibility, replicability, sample size determination, clinical trial design, Alzheimer's disease, mild cognitive impairment, neuropsychological assessment, motion sensors, statistical power

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