ArticleEuropean journal of epidemiology2018
The importance of endpoint selection: How effective does a drug need to be for success in a clinical trial of a possible Alzheimer's disease treatment?
Article in European journal of epidemiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled 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.
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.
Who cites it
21 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Effect of hearing aids on cognitive functions in middle-aged and older adults with hearing loss: A systematic review and meta-analysis.Frontiers in aging neuroscience · 2022Pooled it
- Clinical Outcome Measure Crosswalks in Alzheimer's Disease: A Systematic Review.Journal of Alzheimer's disease : JAD · 2021Pooled it
- Trial
- Smartphone-based detection of subtle memory decline in prodromal Alzheimer's disease.NPJ digital medicine · 2026Article
- A real-world feasibility study: at home longitudinal use of the Cumulus NeuLogiq® platform for electrophysiological and neurocognitive measures in patients with mild Alzheimer's Disease dementia.Frontiers in digital health · 2026Article
- Qualitative research and literature review support the integrated Alzheimer's Disease Rating Scale (iADRS) content validity in early symptomatic AD.The journal of prevention of Alzheimer's disease · 2025Review
- Mobility-Based Smartphone Digital Phenotypes for Unobtrusively Capturing Everyday Cognition, Mood, and Community Life-Space in Older Adults: Feasibility, Acceptability, and Preliminary Validity Study.JMIR human factors · 2024Article
- Safety and efficacy of intranasal insulin in patients with Alzheimer's disease: a systematic review and meta-analysis.Journal of clinical and translational research · 2023Review
- Assessing the Clinical Meaningfulness of the Alzheimer's Disease Composite Score (ADCOMS) Tool.Neurology and therapy · 2022Article
- Staging Disease Severity Using the Alzheimer's Disease Composite Score (ADCOMS): A Retrospective Data Analysis.Neurology and therapy · 2022Article
- Improving Assessment of Disease Severity and Strategies for Monitoring Progression in Degenerative Cervical Myelopathy [AO Spine RECODE-DCM Research Priority Number 4].Global spine journal · 2022Article
- Impact of non-binding FDA guidances on primary endpoint selection in Alzheimer's disease trials.Alzheimer's & dementia (New York, N. Y.) · 2022Article
- Developing the ATX(N) classification for use across the Alzheimer disease continuum.Nature reviews. Neurology · 2021Review
- Identifying Sensitive Measures of Cognitive Decline at Different Clinical Stages of Alzheimer's Disease.Journal of the International Neuropsychological Society : JINS · 2021Article
- Safety and efficacy of sargramostim (GM-CSF) in the treatment of Alzheimer's disease.Alzheimer's & dementia (New York, N. Y.) · 2021Article
- Objectives, design and main findings until 2020 from the Rotterdam Study.European journal of epidemiology · 2020Article
- A precision medicine framework using artificial intelligence for the identification and confirmation of genomic biomarkers of response to an Alzheimer's disease therapy: Analysis of the blarcamesine (ANAVEX2-73) Phase 2a clinical study.Alzheimer's & dementia (New York, N. Y.) · 2020Article
- The Cognitive-Functional Composite is sensitive to clinical progression in early dementia: Longitudinal findings from the Catch-Cog study cohort.Alzheimer's & dementia (New York, N. Y.) · 2020Article
- Combining hippocampal volume metrics to better understand Alzheimer's disease progression in at-risk individuals.Scientific reports · 2019Article
- Broadening the scope of epidemiologic dementia research.European journal of epidemiology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
Abstract
To date, Alzheimer's disease (AD) clinical trials have been largely unsuccessful. Failures have been attributed to a number of factors including ineffective drugs, inadequate targets, and poor trial design, of which the choice of endpoint is crucial. Using data from the Alzheimer's Disease Neuroimaging Initiative, we have calculated the minimum detectable effect size (MDES) in change from baseline of a range of measures over time, and in different diagnostic groups along the AD development trajectory. The Functional Activities Questionnaire score had the smallest MDES for a single endpoint where an effect of 27% could be detected within 3 years in participants with Late Mild Cognitive Impairment (LMCI) at baseline, closely followed by the Clinical Dementia Rating Sum of Boxes (CDRSB) score at 28% after 2 years in the same group. Composite measures were even more successful than single endpoints with an MDES of 21% in 3 years. Using alternative cognitive, imaging, functional, or composite endpoints, and recruiting patients that have LMCI could improve the success rate of AD clinical trials.
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Registered trials
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.