Prof. Frank Jessen, MD, Department of Psychiatry, University of Cologne, Kerpener Strasse 62, 50937 Cologne, Germany, Tel.: +49-(0)221 478-4010 e-mail:
J Prev Alzheimers Dis. 2024;11(5):1212-1218. doi: 10.14283/jpad.2024.153.
β-amyloid-targeting antibodies represent the first generation of effective causal treatment of Alzheimer's disease (AD) and can be considered historical research milestones. Their effect sizes, side effects, implementation challenges and costs, however, have stimulated debates about their overall value. In this position statement academic clinicians of the European Alzheimer's Disease Consortium (EADC) discuss the critical relevance of introducing these new treatments in clinical care now. Given the complexity of AD it is unlikely that molecular single-target treatments will achieve substantially larger effects than those seen with current β-amyloid-targeting antibodies. Larger effects will most likely only be achieved incrementally by continuous optimization of molecular approaches, patient selection and combinations therapies. To be successful in this regard, drug development must be informed by the use of innovative treatments in real world practice, because full understanding of all facets of novel treatments requires experience and data of real-world care beyond those of clinical trials. Regarding the antibodies under discussion we consider their effects meaningful and potential side effects manageable. We assume that the number of eventually treated patient will only be a fraction of all early AD patients due to narrow eligibility criteria and barriers of access. We strongly endorse the use of these new compound in clinical practice in selected patients with treatment documentation in registries. We understand this as a critical step in advancing the field of AD treatment, and in shaping the health care systems for the new area of molecular-targeted treatment of neurodegenerative diseases.
β-淀粉样蛋白靶向抗体代表了阿尔茨海默病(AD)第一代有效病因治疗药物,可以被视为具有历史意义的研究里程碑。然而,这些药物的疗效、副作用、实施挑战和成本引发了关于其总体价值的争论。在此立场声明中,欧洲阿尔茨海默病联合会(EADC)的临床学术专家讨论了现在在临床护理中引入这些新治疗方法的关键相关性。鉴于 AD 的复杂性,单一分子靶向治疗不太可能产生比当前β-淀粉样蛋白靶向抗体更大的效果。更大的效果很可能只能通过不断优化分子方法、患者选择和联合治疗来逐步实现。在这方面取得成功,药物开发必须借鉴实际应用中的创新治疗方法,因为要全面了解新型治疗方法的各个方面,需要在临床试验之外的真实世界护理中积累经验和数据。关于正在讨论的这些抗体,我们认为它们的疗效有意义,潜在的副作用可以控制。我们假设,由于严格的入选标准和准入障碍,最终接受治疗的患者数量只会是所有早期 AD 患者的一小部分。我们强烈支持在有治疗记录的登记处中,为选定的患者在临床实践中使用这些新化合物。我们认为这是推进 AD 治疗领域和为神经退行性疾病的分子靶向治疗这一新领域塑造医疗保健系统的关键步骤。