ArticleJournal of Alzheimer's disease : JAD2017
Sample Size Estimation for Alzheimer's Disease Trials from Japanese ADNI Serial Magnetic Resonance Imaging.
Article in Journal of Alzheimer's disease : JAD, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
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Who cites it
15 citing papers in PubMed, 42 citations in OpenAlex.
- The roles of biomarkers in Alzheimer's disease clinical trials.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2026Review
- Early Alzheimer's Disease Detection: A Review of Machine Learning Techniques for Forecasting Transition from Mild Cognitive Impairment.Diagnostics (Basel, Switzerland) · 2024Review
- Polygenic effects on the risk of Alzheimer's disease in the Japanese population.Alzheimer's research & therapy · 2024Article
- Higher longitudinal brain white matter atrophy rate in aquaporin-4 IgG-positive NMOSD compared with healthy controls.Scientific reports · 2023Article
- Forecasting individual progression trajectories in Alzheimer's disease.Nature communications · 2023Article
- Non-standard pipeline without MRI has replicability in computation of Centiloid scale values for PiB andNeuroimage. Reports · 2022Article
- Limitations of clinical trial sample size estimate by subtraction of two measurements.Statistics in medicine · 2022Article
- Predicting progression to dementia with "comprehensive visual rating scale" and machine learning algorithms.Frontiers in neurology · 2022Article
- Coping in Mid- to Late Life and Risk of Mild Cognitive Impairment Subtypes and Dementia: A JPHC Saku Mental Health Study.Journal of Alzheimer's disease : JAD · 2022Article
- Plasma phospholipid n-3 polyunsaturated fatty acids and major depressive disorder in Japanese elderly: the Japan Public Health Center-based Prospective Study.Scientific reports · 2021Article
- Evaluation of PiB visual interpretation with CSF Aβ and longitudinal SUVR in J-ADNI study.Annals of nuclear medicine · 2020Article
- The association between midlife serum high-density lipoprotein and mild cognitive impairment and dementia after 19 years of follow-up.Translational psychiatry · 2019Article
- The association between "Brain-Age Score" (BAS) and traditional neuropsychological screening tools in Alzheimer's disease.Brain and behavior · 2018Article
- Anserine/Carnosine Supplementation Preserves Blood Flow in the Prefrontal Brain of Elderly People Carrying APOE e4.Aging and disease · 2018Article
- The effect of diagnostic criteria on outcome measures in preclinical and prodromal Alzheimer's disease: Implications for trial design.Alzheimer's & dementia (New York, N. Y.) · 2017Article
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
Abstract
backgroundLittle is known about the sample sizes required for clinical trials of Alzheimer's disease (AD)-modifying treatments using atrophy measures from serial brain magnetic resonance imaging (MRI) in the Japanese population.
objectiveThe primary objective of the present study was to estimate how large a sample size would be needed for future clinical trials for AD-modifying treatments in Japan using atrophy measures of the brain as a surrogate biomarker.
methodsSample sizes were estimated from the rates of change of the whole brain and hippocampus by the k-means normalized boundary shift integral (KN-BSI) and cognitive measures using the data of 537 Japanese Alzheimer's Neuroimaging Initiative (J-ADNI) participants with a linear mixed-effects model. We also examined the potential use of ApoE status as a trial enrichment strategy.
resultsThe hippocampal atrophy rate required smaller sample sizes than cognitive measures of AD and mild cognitive impairment (MCI). Inclusion of ApoE status reduced sample sizes for AD and MCI patients in the atrophy measures.
conclusionThese results show the potential use of longitudinal hippocampal atrophy measurement using automated image analysis as a progression biomarker and ApoE status as a trial enrichment strategy in a clinical trial of AD-modifying treatment in Japanese people.
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Registered trials
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