ArticleAlzheimer's & dementia : the journal of the Alzheimer's Association2023
Why a clinical trial is as good as its outcome measure: A framework for the selection and use of cognitive outcome measures for clinical trials of Alzheimer's disease.
Article in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 3 of them syntheses that pooled it.
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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.
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Who cites it
55 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Efficacy Measures Used in Alzheimer Disease Clinical Trials Between 2015 and 2025: A Systematic Review.Neurology · 2026Pooled it
- Effectiveness of technology-based exercise on motor function and quality of life in individuals with multiple sclerosis: an umbrella review.Journal of health, population, and nutrition · 2025Pooled it
- The Mediterranean-Dietary Approaches to Stop Hypertension Intervention for Neurodegenerative Delay (MIND) Diet for the Aging Brain: A Systematic Review.Advances in nutrition (Bethesda, Md.) · 2024Pooled it
- Outcomes reported in interventional studies for mild cognitive impairment: a scoping umbrella review to inform core outcome set development.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Research satisfaction among participants in a preclinical Alzheimer's disease trial.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Measures used to evaluate psychosocial interventions in dementia care: A narrative review and synthesis.Journal of Alzheimer's disease : JAD · 2026Review
- Smartphone-based detection of subtle memory decline in prodromal Alzheimer's disease.NPJ digital medicine · 2026Article
- Evaluating self- and informant-reported complaints as predictors of cognitive progression in subjective cognitive decline: A clinically-based evaluation.Journal of Alzheimer's disease : JAD · 2026Article
- Cognitive Trajectories from Preclinical Alzheimer's Disease to Dementia.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- Taming the "death receptor": translating the first-in-class p75Journal of translational medicine · 2026Review
- A review of evidence supporting amyloid beta reduction as a surrogate endpoint in Alzheimer's disease.The journal of prevention of Alzheimer's disease · 2026Review
- Remote digital cognitive assessment for aging and dementia using the Oxford Cognitive Testing Portal OCTAL.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
- Validity of gold-standard clinical outcome assessments in U.S. Latinx-Hispanic participants enrolled in Alzheimer's disease clinical trials: A literature review.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Review
- Neuroinflammation PET and long-term cognition and survival in symptomatic Alzheimer's disease.Alzheimer's research & therapy · 2025Article
- Targeting Neurodegeneration with SGLT2is: From Molecular Mechanisms to Clinical Implications.Molecular neurobiology · 2025Review
- Misclassification in memory modification ineLife · 2025Article
- Speech-based digital cognitive assessments for detection of mild cognitive impairment: Validation against paper-based neurocognitive assessment scores.Journal of Alzheimer's disease : JAD · 2025Article
- Infection-Control Protocol Acceptability in Skilled Nursing Facilities During the COVID-19 Pandemic.Journal of the American Medical Directors Association · 2025Article
- Everyday functioning in young onset dementia: differences between diagnostic groups.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Article
Corrections and comments
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Authors and funding
13 authors.
Funding
Abstract
A crucial aspect of any clinical trial is using the right outcome measure to assess treatment efficacy. Compared to the rapidly evolved understanding and measurement of pathophysiology in preclinical and early symptomatic stages of Alzheimer's disease (AD), relatively less progress has been made in the evolution of clinical outcome assessments (COAs) for those stages. The current paper aims to provide a benchmark for the design and evaluation of COAs for use in early AD trials. We discuss lessons learned on capturing cognitive changes in predementia stages of AD, including challenges when validating novel COAs for those early stages and necessary evidence for their implementation in clinical trials. Moving forward, we propose a multi-step framework to advance the use of more effective COAs to assess clinically meaningful changes in early AD, which will hopefully contribute to the much-needed consensus around more appropriate outcome measures to assess clinical efficacy of putative treatments. HIGHLIGHTS: We discuss lessons learned on capturing cognitive changes in predementia stages of AD. We propose a framework for the design and evaluation of performance based cognitive tests for use in early AD trials. We provide recommendations to facilitate the implementation of more effective cognitive outcome measures in AD trials.
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