Affiliations: [a] Science Norms Democracy UMR 8011, Sorbonne Université, Paris, France
| [b] Bioethics Program, FLACSO Argentina, Buenos Aires, Argentina
Correspondence:
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Correspondence to: Timothy Daly, PhD, Bioethics Program, FLACSO Argentina, Buenos Aires, Argentina. E-mail: [email protected].
Abstract: Maintaining diversity in drug development in research into Alzheimer’s disease (AD) is necessary to avoid over-reliance on targeting AD neuropathology. Treatments that reduce or prevent the generation of oxidative stress, frequently cited for its causal role in the aging process and AD, could be useful in at-risk populations or diagnosed AD patients. However, in this review, it is argued that clinical research into antioxidants in AD could provide more useful feedback as to the therapeutic value of the oxidative stress theory of AD. Improving comparability between randomized controlled trials (RCTs) is vital from a waste-reduction and priority-setting point of view for AD clinical research. For as well as attempting to improve meaningful outcomes for patients, RCTs of antioxidants in AD should strive to maximize the extraction of clinically useful information and actionable feedback from trial outcomes. Solutions to maximize information flow from RCTs of antioxidants in AD are offered here in the form of checklist questions to improve ongoing and future trials centered around the following dimensions: adhesion to reporting guidelines like CONSORT, biomarker enrichment, simple tests of treatment, and innovative trial design.
Keywords: Alzheimer’s disease, antioxidants, biomarkers, clinical trials, drug pipeline, information flow, oxidative stress, standardization, trial innovation
