Trial reportAlzheimer's & dementia : the journal of the Alzheimer's Association2014
Simulating effects of biomarker enrichment on Alzheimer's disease prevention trials: conceptual framework and example.
Trial report in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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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.
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Who cites it
5 citing papers in PubMed.
- Imaging-based enrichment criteria using deep learning algorithms for efficient clinical trials in mild cognitive impairment.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2015Article
- Five-year biomarker progression variability for Alzheimer's disease dementia prediction: Can a complex instrumental activities of daily living marker fill in the gaps?Alzheimer's & dementia (Amsterdam, Netherlands) · 2015Article
- Use of High-Frequency In-Home Monitoring Data May Reduce Sample Sizes Needed in Clinical Trials.PloS one · 2015Article
- Latent Classes of Neuropsychiatric Symptoms in NACC Controls and Conversion to Mild Cognitive Impairment or Dementia.Journal of Alzheimer's disease : JAD · 2015Article
- Big Data Analytical Approaches to the NACC Dataset: Aiding Preclinical Trial Enrichment.Alzheimer disease and associated disordersArticle
Corrections and comments
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Authors and funding
4 authors.
Funding
Abstract
backgroundWe present a conceptual framework for simulations to determine the utility of biomarker enrichment to increase statistical power to detect a treatment effect in future Alzheimer's disease prevention trials. We include a limited set of simulation results to illustrate aspects of this framework.
methodsWe simulated data based on the Alzheimer's Disease Anti-Inflammatory Prevention Trial, and a range of sample sizes, biomarker positive predictive values, and treatment effects. We also investigated the consequences of assuming homogeneity of parameter estimates as a function of dementia outcome.
resultsUse of biomarkers to increase the sample fraction that would develop Alzheimer's disease in the absence of intervention from 0.5 to 0.8 would increase power from 0.35 to 0.69 with n = 200. Ignoring sample heterogeneity resulted in overestimation of power.
conclusionBiomarker enrichment can increase statistical power, but estimates of the expected increase are sensitive to a variety of assumptions outlined in the framework.
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Registered trials
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