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Ethical Considerations in Alzheimer's Drug Trials

Le Dieu Nhu s48001362 16/12/2023 A 2021 trial conducted by Swanson et al. tested various doses of Lecanemab in 856 early- stage Alzheimer's patients for optimal efficacy, which was 90% of the maximum effect (ED90). Assessments include the Alzheimer's Disease Composite Score (ADCOMS), cerebrospinal fluid (CSF), and blood tests were done at baseline, 12 and 18 months. Participants were allocated to 6 groups of dosage infusions (placebo, 2.5, 5, and 10 mg/kg biweekly/monthly). The result showed a 30% less clinical decline in patients treated with the 10 mg/kg biweekly dose compared to the placebo, with a P value of 0.034. After analysis and cross-comparison, I can argue that this study is ethical as it aligns with Australian Medical Board ethics principles and is supported by key elements outlined in Rutnam's 1988 paper. Consent was mandatory for this research involving drug administration as well as CSF and blood collection (lumbar puncture and vein draw). The paper confirms full consent for all subjects in data collection as well as optional sub-studies. Participants' withdrawal and sample destruction rights were also ensured. (Appendix A, page. 139) In addition to consent, the safety evaluations of the participants were also taken into consideration. Page. 24 states that participants are ensured to be provided with additional physical examinations and screening of vital signs for out-of-normal-range findings. Sample collection and handling procedures followed a protocol that ensured that they were following the study flow chart and were contingency-proofed (Appendix A, page. 138). The presence of risks was displayed on Page. 87 of Appendix A, listing out potential life- threatening scenarios and risks of death. Other important medical events that may not be immediately life-threatening were also addressed with proper procedures. The diagnosed patients were allocated by a computer algorithm modelled on the ADCOMS database to doses that have the highest chance of being their ED90, minimizing the number of patients getting suboptimal treatment. Furthermore, Appendix A, page. 139, also elaborated that participants' identifying information was not associated with the samples, preventing bias. The paper also showed transparency to readers as the limitations of the research were explained and fully acknowledged on Page. 12. However, there was no specific mention of the participants' welfare or quality of life while undergoing research. The only way one could assume that they are being provided with the necessary amenities is found in the declaration that this trial was approved by an independent ethics committee. (Page. 13) There were also a notable number of complications and adverse events that occurred during the treatment, which raises an ethical concern. Nonetheless, the paper provided a full, transparent record of all treatment-emergent adverse events (TEAEs) and addressed the types of TEAEs that occurred as well as their correlation among the subject population. (Table 3, page. 10) In conclusion, this paper has tackled the concept of medical treatment and research being involved in the ambiguity of human physiology. Weighing the risks and recorded adverse events against the outcome, this research has met ethical standards from a utilitarian