Angela Bradshaw, Alzheimer Europe, Luxembourg,
J Prev Alzheimers Dis. 2024;11(2):265-273. doi: 10.14283/jpad.2024.37.
The growing prevalence and burden of Alzheimer's disease has catalysed huge investments in research on its causes, diagnosis, treatment and care. After many high-profile failures, recent clinical trials of anti-amyloid drugs have marked a turning point for the field, leading to the approval of the first disease-modifying therapies for Alzheimer's disease by the FDA. It is now up to European regulators to determine whether there is sufficient evidence to approve these drugs for patients with mild cognitive impairment or mild dementia due to Alzheimer's disease. Here, we outline Alzheimer Europe's position on anti-amyloid therapies for Alzheimer's disease, which was adopted by the Board of Alzheimer Europe following consultations with our member associations and with the European Working Group of People with Dementia. Beyond questions of drug efficacy, safety and cost, we highlight important issues that must be addressed by industry, regulators, payers, healthcare systems and governments, to ensure that patients have timely, appropriate and equitable access to innovative treatments, regardless of their socio-economic background, insurance status, or place of residence. We also call for continued investment in research on treatments that might benefit people with more advanced Alzheimer's disease - as well as support and care services that can help people live well with dementia at all stages of the disease.
阿尔茨海默病的发病率和负担不断增加,这促使人们对其病因、诊断、治疗和护理进行了大量投资。在多次备受瞩目的失败之后,最近针对抗淀粉样蛋白药物的临床试验为该领域带来了一个转折点,导致 FDA 批准了首个用于治疗阿尔茨海默病的疾病修正疗法。现在,由欧洲监管机构决定是否有足够的证据批准这些药物用于轻度认知障碍或轻度痴呆症患者。在此,我们概述了阿尔茨海默病欧洲协会对阿尔茨海默病抗淀粉样蛋白疗法的立场,该立场在与我们的成员协会以及欧洲痴呆症患者工作组协商后,由阿尔茨海默病欧洲理事会通过。除了药物疗效、安全性和成本问题外,我们还强调了行业、监管机构、支付方、医疗保健系统和政府必须解决的重要问题,以确保无论患者的社会经济背景、保险状况或居住地点如何,都能及时、适当地获得创新治疗。我们还呼吁继续投资于可能使更多患有晚期阿尔茨海默病的人受益的治疗方法,以及支持和护理服务,以帮助人们在疾病的各个阶段都能良好地生活。