Safety concerns for the new anti-amyloid therapies are such that 1) The patients should be made aware of all possible effects of the treatment and 2) Physicians and practitioners should be systematically tracking the administration of the drugs that are interspersed with regularly scheduled MRIs. Any concerns should be brought up immediately, communication is key to the success of these new therapeutics.

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Anti-amyloid therapies are slowing the progression of Alzheimer's dementia, but they are not without risks. The main risk is amyloid-related imaging abnormalities [ARIAs] which can be brain swelling or microhemorrhages in the brain. Because of the possible risk of ARIAs, steps need to be put in place to carefully monitor and manage the patient's progress with the treatments.

 

There are currently 2 FDA-approved ATTs in the United States: lecanemab (Leqembi; Eisai, Nutley, NJ; accelerated approval January 2023, traditional approval July 2023) and donanemab (Kisunla; Eli Lilly, Indianapolis, IN; approved July 2024). These therapies mark a dramatic pharmacologic change for the treatment of mild cognitive impairment and mild dementia due to AD, and they have different infrastructural requirements. ATTs require a more extensive diagnostic, treatment, and monitoring process and increased participation of health care personnel compared with previous therapies (eg, acetylcholinesterase inhibitors, memantine, neuropsychiatric management). It is crucial that AD be diagnosed and disclosed in a timely manner. Initial clinical visits should focus on the clinical stage of the disease, overall health and comorbid conditions, and caregiver support. Later visits should include discussions with patients based on genetic and imaging findings, evidence of amyloid in cerebrospinal fluid samples or positron emission tomography images, and careful and thoughtful selection for therapy which requires informed patient consent. After beginning ATT therapy, individuals with AD require appropriate MRI monitoring, infusion scheduling, ARIA management, and ongoing discussions with physicians to ensure compliance, expectations, and understanding*. 

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What is your plan to safely administer these drugs? Is it a spreadsheet? Is it an app? Is it paper? What checklists are in place prior to the first dose? 

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The paradigm shift associated with the emergence of ATTs has created the need for new clinical systems and workflows, interdisciplinary teams, and technical expertise for effective ATT administration. Treating physicians find themselves in various stages of motivation and readiness; however, individuals and families interested in pursuing ATT are often placed on a waiting list. In this article, we describe the components of an optimal ATT program, including workflow, staffing, oversight, and billing considerations; flexibility needs; and troubleshooting pointers. An optimal ATT program can help physicians maximize patient wellbeing, autonomy, and safety. Every program should be built for optimal flow while anticipating potential barriers which could disrupt patient care*.

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*Weisman, D., & Cabral, D. (2025, July 25). Building an infrastructure to administer amyloid-targeting treatments. Practical Neurology. https://practicalneurology.com/diseases-diagnoses/alzheimer-disease-dementias/building-an-infrastructure-to-administer-amyloid-targeting-treatments/36187/