The Alzheimer's Association Clinical Meaningfulness Workgroup developed recommendations to help health care providers explain novel anti-amyloid treatments, focusing on balancing hope with realism, discussing potential risks like amyloid-related imaging abnormalities (ARIA), and personalizing care plans.

"Benefits and risks of FDA-approved amyloid-targeting antibodies for treatment of early Alzheimer's disease: Navigating clinician-patient engagement", published in late 2024 in Alzheimer’s & Dementia®: The Journal of the Alzheimer’s Association, discusses the complexities surrounding the use of amyloid-targeting therapies approved by the FDA for treating early-stage Alzheimer’s disease. It emphasizes the need for clear and empathetic communication between clinicians, patients and caregivers regarding treatment eligibility, risks, benefits and costs. The paper also stresses the importance of APOE genotyping, ongoing monitoring and managing the logistical and financial burdens associated with treatment.

Background

The Alzheimer's Association Clinical Meaningfulness Workgroup was formed in 2022 as part of the Association’s efforts to provide resources for clinicians in communicating about the benefits and risks of FDA-approved amyloid-targeting therapies for Alzheimer's disease. This workgroup brought together experts in dementia care, academia, drug development and the clinical community. They also sought input from experienced clinicians outside the academic and industry communities, and the Alzheimer’s Association Early-Stage Advisory Group (ESAG), which includes individuals with early-stage Alzheimer's or mild cognitive impairment, to incorporate patient perspectives.

Recommendations

FDA-approved amyloid targeting antibody therapies for Alzheimer's disease offer hope to those living with the disease and their families by slowing disease progression. However, these treatments are not cures, and careful management is required. The Alzheimer's Association's Clinical Meaningfulness Workgroup's recommendations help health care providers explain these novel treatments through a patient-first approach by emphasizing the importance of balancing hope with realism, discussing potential benefits and risks like amyloid-related imaging abnormalities (ARIA) and personalizing care plans.

The workgroup’s recommendations include:

• Balanced communication: Clearly communicate the potential benefits and risks of FDA-approved amyloid-targeting antibodies for early Alzheimer's. Balance optimism with realism, ensuring patients and caregivers understand that these treatments can slow disease progression but are not cures.

• Eligibility and personalization: Tailor discussions about treatment eligibility based on individual patient factors, including disease stage, overall health and genetic markers like APOE status. Personalize care plans to align with each patient’s goals and circumstances.

• Informed consent and risks: Emphasize the importance of informed consent by thoroughly explaining the potential side effects, particularly ARIA. Discuss how these risks will be managed throughout treatment, including the need for regular monitoring.

• APOE genotyping: Encourage APOE genotyping for patients considering amyloid-targeting therapies, as it can provide critical information about risk profiles, particularly in relation to ARIA.

• Ongoing monitoring and safety: Highlight the necessity of close, ongoing monitoring during treatment, including frequent imaging and clinical evaluations to detect and manage any adverse effects or complications.

• Financial and logistical considerations: Discuss the financial and logistical aspects of treatment, including costs, insurance coverage, and the travel and time commitment required for repeated clinic visits, treatment infusions and monitoring. Help patients and caregivers navigate these challenges.

• Support for caregivers: Engage with caregivers as key partners in care, providing them with resources and information about managing the disease, treatment logistics and their role in monitoring for side effects or changes in the patient’s condition.

• Holistic care approach: Encourage a holistic approach to care that goes beyond amyloid-targeting therapies, which may include incorporating lifestyle interventions, supporting mental health, and addressing the emotional and psychological needs of both patients and caregivers. 

Summary tool and checklist for clinicians

A summary tool and checklist for clinicians will be available soon.

2022 clinical meaningfulness workgroup members

The Alzheimer’s Association Clinical Meaningfulness Workgroup includes members from industry, academia, the clinical community and the Alzheimer’s Association. Individual ICMJE disclosure forms detailing workgroup members' relationships, activities and interests are linked in the published manuscript. 

Contact us

Questions and concerns about the Alzheimer's Association Clinical Meaningfulness Workgroup can be directed to Christopher Weber, Ph.D., senior director, Global Science Initiatives at cweber@alz.org.