The availability of US Food and Drug Administration (FDA)-approved therapies for early Alzheimer's disease (AD) challenges clinicians and health-care providers with effectively communicating the risks, benefits, burdens, costs and available support associated with these treatments to patients, families, and other health-care providers. The task is essential but complex.

The Alzheimer's Association Clinical Meaningfulness Workgroup has developed recommendations and suggested language to help health-care providers explain newly approved AD treatments to patients and caregivers. “Benefits and Risks of FDA-Approved Amyloid-Targeting Antibodies for Treatment of Early Alzheimer's Disease: Navigating Clinician-Patient Engagement” was published online October 15.¹

The paper focuses on FDA-approved amyloid-targeting antibody therapies for early AD, which offer hope by slowing disease progression. However, these treatments are not cures, and thoughtful management—including ongoing, clear, factual communication—is required.

“The language and guidance in the article emphasizes the need for clear and empathetic communication between clinicians, patients, and caregivers regarding treatment eligibility, risks, benefits, and costs,” said Maria C. Carrillo, PhD, Alzheimer's Association chief science officer and medical affairs lead, and senior author on the article. “It also stresses the importance of genetic testing in advance, ongoing monitoring for side effects, and managing the logistical and financial issues associated with treatment.”

“This effort was catalyzed by Alzheimer's patients and families sharing their enthusiasm, but also their concerns—telling us what they want and need to know about these drugs, and the confusion and discord they have experienced because of the contentious public discussion about the FDA-approved treatments for early Alzheimer's,” Carrillo explained. “The issues are complex, but can be discussed in a way that everyone can understand. We do this for cancer treatment. We can do this for Alzheimer's.”

The Workgroup was formed in 2022 as part of the Alzheimer's Association's efforts to provide resources for clinicians about the benefits and risks of FDA-approved amyloid-targeting therapies for AD. It brought together experts in dementia care, academia, drug development, and the clinical community. The Workgroup received input from experienced clinicians outside the academic and industry communities and from the Alzheimer's Association Early-Stage Advisory Group, which includes individuals with early Alzheimer's dementia or mild cognitive impairment, to incorporate patient perspectives.

“As new Alzheimer's therapies are approved, there may be different risks and expectations,” said Dorene M. Rentz, PsyD, professor of neurology, Harvard Medical School, and lead author of the paper. “Our goal is to update this resource to facilitate those discussions, as needed.”

“The Alzheimer's Association is committed to providing dementia professionals with guidance to tackle challenges in the fight against Alzheimer's,” Carrillo said.

美国食品药品监督管理局 （FDA） 批准的早期阿尔茨海默病 （AD） 疗法的可用性要求临床医生和医疗保健提供者有效地将与这些治疗相关的风险、益处、负担、成本和可用支持传达给患者、家庭和其他医疗保健提供者。这项任务是必不可少的，但很复杂。

阿尔茨海默病协会临床意义工作组制定了建议和建议的语言，以帮助医疗保健提供者向患者和护理人员解释新批准的 AD 治疗方法。10 月 15 日，“FDA 批准的淀粉样蛋白靶向抗体治疗早期阿尔茨海默病的益处和风险：引导临床医生-患者参与”在线发布。¹

该论文重点介绍了 FDA 批准的针对早期 AD 的淀粉样蛋白靶向抗体疗法，该疗法通过减缓疾病进展带来了希望。然而，这些治疗并不能治愈，需要周到的管理，包括持续、清晰、事实性的沟通。

“文章中的语言和指导强调了临床医生、患者和护理人员之间就治疗资格、风险、收益和成本进行清晰和善解人意的沟通的必要性，”阿尔茨海默病协会首席科学官兼医疗事务负责人、文章的资深作者 Maria C. Carrillo 博士说。“它还强调了提前进行基因检测、持续监测副作用以及管理与治疗相关的后勤和财务问题的重要性。”

“这项努力是由阿尔茨海默病患者和家人分享他们的热情和他们的担忧所推动的——告诉我们他们想和需要了解的有关这些药物的信息，以及他们由于关于 FDA 批准的早期阿尔茨海默病治疗方法的有争议的公开讨论而经历的困惑和不和谐，”Carrillo 解释说。“这些问题很复杂，但可以以每个人都能理解的方式进行讨论。我们这样做是为了癌症治疗。我们可以为阿尔茨海默氏症做这件事。

该工作组成立于 2022 年，是阿尔茨海默病协会努力的一部分，旨在为临床医生提供有关 FDA 批准的淀粉样蛋白靶向治疗 AD 的益处和风险的资源。它汇集了痴呆护理、学术界、药物开发和临床界的专家。该工作组收到了来自学术和行业界之外经验丰富的临床医生以及阿尔茨海默病协会早期咨询小组的意见，该小组包括患有早期阿尔茨海默病痴呆或轻度认知障碍的个体，以纳入患者的观点。

“随着新的阿尔茨海默病疗法获得批准，可能会有不同的风险和预期，”哈佛医学院神经病学教授、该论文的主要作者、心理学博士 Dorene M. Rentz 说。“我们的目标是根据需要更新此资源以促进这些讨论。”

“阿尔茨海默氏症协会致力于为痴呆症专业人士提供指导，以应对与阿尔茨海默氏症作斗争的挑战，”卡里略说。