The FDA has approved the monoclonal antibody donanemab, a groundbreaking treatment for early Alzheimer’s disease (AD), marking a significant milestone in geriatric psychiatry. Donanemab, developed by Eli Lilly and marketed as Kisunla, has shown promise in slowing the progression of AD in clinical trials, offering new hope for patients and their families.

The approval is based on data from the TRAILBLAZER-ALZ 2 study, which demonstrated that monthly intravenous donanemab infusion significantly slowed cognitive and functional decline in patients with early symptomatic AD or mild cognitive impairment (MCI). The study enrolled over 1,700 participants, with results showing a 35% reduction in the rate of decline compared to placebo over an 18-month period. Notably, patients in the early stages of the disease with confirmed elevated beta-amyloid plaques in the brain experienced the most pronounced benefits.

Donanemab works by targeting beta-amyloid plaques. By binding to and facilitating the removal of these plaques, the drug aims to modify the disease process itself rather than merely alleviating symptoms. This mechanism may offer a new therapeutic avenue for clinicians to manage patients with AD, potentially altering the standard of care. Similar to treatment with the monoclonal agents aducanumab and lecanemab, amyloid-related imaging abnormalities (ARIAs) may occur, so repeat MRI monitoring is recommended.

Although the approval of donanemab represents a significant advancement in the arsenal of treatments available for AD, its long-term safety and efficacy are not yet fully understood. Real-world data will be essential in evaluating donanemab’s overall impact. Furthermore, the cost and accessibility of the treatment may pose challenges for widespread adoption.