ReviewClinical and translational science2020
US, EU, and Japanese Regulatory Guidelines for Development of Drugs for Treatment of Alzheimer's Disease: Implications for Global Drug Development.
Review in Clinical and translational science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis 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
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Glaucoma Is Not Associated With Alzheimer's Disease or Dementia: A Meta-Analysis of Cohort Studies.Frontiers in medicine · 2021Pooled it
- Memory Cells in Atopic Dermatitis: Paving the Way to Disease Modification.International journal of molecular sciences · 2026Review
- Challenges and Opportunities of Drug Delivery for Treatment of Alzheimer's Disease.AAPS PharmSciTech · 2026Review
- Clinical trials for Wolfram syndrome neurodegeneration: Novel design, endpoints, and analysis models.PloS one · 2025Article
- The association between antiglaucomatous agents and Alzheimer's disease.Eye (London, England) · 2024Article
- Return on investment in science: twenty years of European Commission funded research in Alzheimer's dementia, breast cancer and prostate cancer.Cost effectiveness and resource allocation : C/E · 2024Article
- Disease-modifying therapies in systemic lupus erythematosus for extrarenal manifestations.Lupus science & medicine · 2024Review
- Latest Trends in Outcome Measures in Dementia and Mild Cognitive Impairment Trials.Brain sciences · 2022Review
- Clinical outcome measures in dementia with Lewy bodies trials: critique and recommendations.Translational neurodegeneration · 2022Review
- Conceptual framework for defining disease modification in systemic lupus erythematosus: a call for formal criteria.Lupus science & medicine · 2022Review
- Looking for a Treatment for the Early Stage of Alzheimer's Disease: Preclinical Evidence with Co-Ultramicronized Palmitoylethanolamide and Luteolin.International journal of molecular sciences · 2020Article
- Utilizing MCID for evaluating clinical relevance of AD therapeutic interventions.Alzheimer's & dementia (New York, N. Y.)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Drug development guidelines from regulatory authorities provide important information to sponsors on requirements for clinical evidence needed to support approval of new drugs. In the field of Alzheimer's disease (AD), recently published guidelines are available from EU, US, and Japanese regulatory authorities. In this review, these three guidelines are compared and discussed with emphasis on the recommendations provided for demonstration of efficacy in pivotal clinical trials conducted in predementia stages of AD. Similarities and differences are highlighted, and impact for global drug development is discussed in the context of the new International Conference on Harmonization E17 guideline on multiregional clinical trials. The AD field is characterized by significant challenges as, to date, no drug approval precedence exists in predementia AD despite numerous and ambitious efforts to slow the progression of the disease by pharmacologic intervention. Despite these uncertainties regulatory authorities across regions have blazed a trail for proactive multistakeholder collaboration, involvement, and continuous dialogue, setting a positive example on how to foster a supportive environment for development of new and meaningful treatments for patients with AD globally.
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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.