ArticleThe journal of prevention of Alzheimer's disease2024
Clinical Meaningfulness in Alzheimer's Disease Clinical Trials. A Report from the EU-US CTAD Task Force.
Article in The journal of prevention of Alzheimer's disease, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed.
- Enhancing Interpretation of Cognitive Changes in Alzheimer's Intervention Trials: Application of Standardized Regression-Based Change Scores.Archives of clinical neuropsychology : the official journal of the National Academy of Neuropsychologists · 2025Trial
- Beyond the Cochrane review: Re-evaluating anti-amyloid therapy in Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Article
- Systemic inflammation, delirium and clinical progression in mild-moderate Alzheimer disease.EBioMedicine · 2026Article
- Clinical meaningfulness of anti-amyloid therapies in early Alzheimer's disease: Perspectives from the East and Southeast Asia region.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026Review
- Associations Between Cognitive Performance and Motor Signs in Older Adults with Alzheimer's Dementia.Medicina (Kaunas, Lithuania) · 2025Article
- Linking traditional and technological activities of daily living: Building modern, adaptable measures of daily functioning.Journal of the International Neuropsychological Society : JINS · 2025Article
- Challenges and opportunities for novel combination therapies in Alzheimer's disease: a report from the EU/US CTAD Task Force.The journal of prevention of Alzheimer's disease · 2025Review
- Safety and effectiveness of the anti-amyloid monoclonal antibody (mAb) drug lecanemab for early Alzheimer's disease: The pharmacovigilance perspective.British journal of clinical pharmacology · 2025Review
- Cost-effectiveness of diagnosing and treating patients with early Alzheimer's disease with anti-amyloid treatment in a clinical setting.Journal of Alzheimer's disease : JAD · 2025Article
- Differential Transcriptional Programs Reveal Modular Network Rearrangements Associated with Late-Onset Alzheimer's Disease.International journal of molecular sciences · 2025Article
- Appropriate use of meaningful within-patient change (MWPC) thresholds in Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2025Article
- The elusive relationship between retinal anatomy and brain amyloid.Brain communications · 2025Article
- Predicting progression from amnestic mild cognitive impairment to Alzheimer's disease using longitudinal EEG data: a 12-month cohort study.Frontiers in aging neuroscience · 2025Article
- Alzheimer's disease drug development in an evolving therapeutic landscape.Alzheimer's & dementia (New York, N. Y.)Article
- Utilizing MCID for evaluating clinical relevance of AD therapeutic interventions.Alzheimer's & dementia (New York, N. Y.)Article
- Measuring time saved in Alzheimer's disease: What is a meaningful slowing of progression?Alzheimer's & dementia (New York, N. Y.)Article
Corrections and comments
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Authors and funding
18 authors.
Funding
Abstract
Recent positive results of three phase III anti-amyloid monoclonal antibody trials are transforming the landscape of disease-modifying therapeutics for Alzheimer's disease, following several decades of failures. Indeed, all three trials have met their primary endpoints. However, the absolute size of the benefit measured in these trials has generated a debate on whether the change scores observed on clinical outcome assessments represent a clinically meaningful benefit to patients. An evidence-based conclusion is urgently required to inform decision-making related to the approval, reimbursement, and ultimately, the management of emerging therapies in clinical practice. The EU-US CTAD Task Force met in Boston to address this important question. The current state-of-the-art knowledge for interpreting clinical meaningfulness of AD clinical trial results, including the point of view of patients and study partners on what is clinically meaningful, was discussed and is summarized here. A combination of methodologies to address the challenges emerged. There remain gaps in the understanding of clinical meaningfulness that only long-term longitudinal studies will be able to address.
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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.