Updated Guidance on Antiamyloid Monoclonal Antibody Treatment in Alzheimer Disease
The American Academy of Neurology has released new guidance on the use of antimyloid monoclonal antibodies (mAbs) for treatment of patients with Alzheimer disease (AD).1
Recent research has shown the benefits of monoclonal antibody infusions targeting amyloid-β protein, such as lecanemab, in the treatment of individuals with early symptomatic AD. However, this emerging treatment option is not yet incorporated into clinical practice guidelines. The authors of this article aimed to provide guidance to clinicians in the interim as new evidence continues to emerge and until formal guidelines are developed.
“As the field enters a new era with disease modifying treatment options for AD, it will be critical for neurology practices to prepare and continually innovate to ensure optimal outcomes for patients,” the authors wrote.
The guidance focuses on the use of lecanemab, which was recently approved by the FDA; aducanumab, which is available under accelerated approval for those participating in a clinical trial; and donanemab, which is expected to be approved by the FDA later this year.
Lecanemab is intended for use in individuals with early, symptomatic AD, mild cognitive impairment, or mild dementia due to AD. Due to a risk of amyloid-related imaging abnormalities, individuals with a history of cerebral macrohemorrhage, large territory ischemic stroke, multiple lacunar strokes, or severe small vessel ischemic disease in cerebral white matter, as well as individuals taking certain anticoagulants should not use lecanemab.
In addition to the potential benefits of antimyloid mAbs, the recommendations discuss limitations of the therapy, including additional cost associated with their use, health care shortages that may impact the additional testing and monitoring needed for these therapies, and lack of diversity in study participants to date.
“There is much optimism that anti-amyloid monoclonal antibodies may facilitate slowing of the disease process in some people with Alzheimer disease,” said Carlayne E. Jackson, MD, in a press release, who is the president of the American Academy of Neurology.2 “Additional research is needed to further determine who may be most likely to benefit from these therapies, as well as to find ways to improve outcomes for people using them and enable future advances in this new era of Alzheimer disease care.”
- Ramanan VK, Armstrong MJ, Choudhury P, et al; AAN Quality Committee. Antiamyloid monoclonal antibody therapy for Alzheimer disease: emerging issues in neurology. Neurology. Published online July 26, 2023. https://n.neurology.org/content/early/2023/07/26/WNL.0000000000207757
- AAN issues guidance on new treatments for early Alzheimer disease. News release. American Academy of Neurology; July 26, 2023. Accessed September 13, 2023. https://www.aan.com/PressRoom/Home/PressRelease/5103#:~:text=AAN%20Issues%20Guidance%20on%20New,been%20affected%20by%20the%20disease.