Positive European Medicines Agency decision on lecanemab highlights importance of AI-Mind's work
On 14 November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting a marketing authorisation to lecanemab for treating mild cognitive impairment (MCI) or early Alzheimer’s disease (AD) in patients who have only one or no copy of ApoE4, a certain form of the gene for the protein apolipoprotein E. This positive opinion could transform the landscape of AD care in Europe, reinforcing the urgency of early detection and risk assessment tools like those being developed by the AI-Mind project.
What is Lecanemab?
Lecanemab is an anti-amyloid monoclonal antibody that binds to amyloid beta, a protein that forms plaques in the brain of people with AD. By attaching to amyloid beta, lecanemab reduces these amyloid plaques in the brain. The approval is based on data demonstrating a 27% reduction in clinical decline after 18 months of treatment on a global cognitive and functional scale. In its opinion, the CHMP found that the benefits of lecanemab for a restricted population outweighed its risks. The AI-Mind project, which focuses on developing artificial intelligence (AI)-based tools for dementia risk prediction in individuals with MCI, views this positive opinion as a validation of its mission. With the emergence of disease-modifying treatments like lecanemab, the need for accurate and timely risk assessment has become more critical than ever. By leveraging AI and machine learning, AI-Mind aims to identify individuals at high risk of developing dementia, enabling earlier intervention and improved care pathways.
Safety measures for Lecanemab
The CHMP details safety precautions to mitigate potential risks associated with the treatment and highlights the importance of careful patient selection and monitoring to ensure the safe use of lecanemab, particularly in vulnerable populations:
- Monitoring for ARIA (Amyloid-Related Imaging Abnormalities): Patients must be closely monitored for ARIA, a known side effect of anti-amyloid therapies, which may include brain swelling or bleeding.
- Regular MRI scans: Periodic MRI scans are necessary before and during treatment to identify and manage potential ARIA symptoms.
- Healthcare professional training: The CHMP emphasises that healthcare providers administering lecanemab must be trained to recognise and address side effects promptly.
- Anticoagulant treatment: Lecanemab must not be used by people receiving anticoagulant treatment as this could increase the risk of developing ARIA.
AI-Mind’s innovative approach aligns closely with the call for action issued by Alzheimer Europe, a partner in the project. Commenting on the CHMP’s recommendation, Alzheimer Europe stated:
“As with many other conditions, this first drug with a new mode of action constitutes an important advance for the Alzheimer’s disease community in Europe. We therefore welcome the positive outcome from the CHMP’s re-examination of lecanemab. In our position paper on anti-amyloid therapies, we called for timely, safe, and equitable access to these medicines.”
The approval process for lecanemab underscores the importance of ensuring equitable access to innovative therapies. AI-Mind’s work in enhancing early detection capabilities is a crucial step in supporting this goal, as early and reliable identification of at-risk individuals is essential for maximising the benefits of new treatments.
As the Alzheimer’s disease community continues to advocate for improved care and treatment options, AI-Mind remains at the forefront of research efforts to address this challenge. The project’s AI-based tools have the potential to complement advances in pharmacological treatments like lecanemab, bridging the gap between diagnosis and therapeutic intervention.
With this decision, the focus now shifts to realising the promise of early detection and intervention—a vision that lies at the heart of the AI-Mind project.
Read the full press release here: https://www.ema.europa.eu/en/news/leqembi-recommended-treatment-early-alzheimers-disease