New Alzheimer’s Treatment Using Donanemab Begins in Milan
The IRCCS Policlinico San Donato in Milan has initiated a novel Alzheimer’s treatment using donanemab, a monoclonal antibody targeting beta-amyloid plaques, according to medical officials. Two patients, aged 63 and 67, are the first to receive the therapy under a compassionate use program, marking a significant step in early-stage Alzheimer’s care.
How Does Donanemab Work?
Donanemab, approved by the U.S. Food and Drug Administration (FDA) in June 2023 and under review by the European Medicines Agency (EMA), works by binding to beta-amyloid plaques in the brain. These plaques are a key biological marker of Alzheimer’s, and their removal is theorized to slow cognitive decline. Clinical trials published in *The New England Journal of Medicine* showed the drug reduced plaque buildup by 72% in treated patients.
Who Is Eligible for the Treatment?
The therapy is restricted to individuals with mild cognitive impairment or early-stage dementia, as determined by strict criteria. Patients undergo comprehensive evaluations, including genetic testing, neuroimaging, and lab work, to ensure suitability. Dr. Salvatore Mazzeo, head of the Center for Cognitive Disorders and Dementias (Cdcd) at San Raffaele University, emphasized the rigorous selection process: “We prioritize patients who show early biological signs of Alzheimer’s to maximize treatment efficacy.”
What Makes This Development Unique?
This treatment represents a shift from symptom management to targeting the disease’s underlying biology. Unlike previous Alzheimer’s drugs, donanemab directly addresses amyloid accumulation, a mechanism supported by the National Institute on Aging (NIA). However, experts caution that its long-term benefits and risks, including brain swelling observed in trials, require further study.
What’s Next for Alzheimer’s Research?
The Milan trial aligns with global efforts to advance early intervention strategies. The Alzheimer’s Association highlights that 60-70% of dementia cases may be linked to biological factors detectable years before symptoms appear. Researchers at San Donato plan to share findings with international consortia to refine treatment protocols.
FAQ
What is donanemab?
A monoclonal antibody designed to target and clear beta-amyloid plaques in the brain, a hallmark of Alzheimer’s disease.
Who can access the treatment?
Currently, only patients with mild cognitive impairment or early dementia who meet specific clinical and imaging criteria, as determined by a multidisciplinary team.
Are there side effects?
Common adverse effects include amyloid-related imaging abnormalities (ARIA), such as brain swelling or microhemorrhages, observed in 12% of trial participants. Close monitoring is required.