On 11 August, academic clinicians from the European Alzheimer’s Disease Consortium (EADC) discussed the critical relevance of introducing β-amyloid-targeting antibody treatments for Alzheimer’s disease (AD) into clinical care. The paper begins by noting the increasing societal burden of dementia before addressing the new treatments currently in development, including anti-amyloid therapies. The target population of these recent clinical trials includes people in the early stages of AD (mild cognitive impairment and mild dementia due to AD). Each drug works slightly differently, by targeting β-amyloid at a different stage of plaque formation.
Aducanumab was the first antibody to show the association of amyloid lowering with slowing of symptomatic decline in a phase 2 clinical trial. Lecanemab was the first antibody with demonstration of clinical efficacy in a phase 3 study. The EADC stressed that while lecanemab has been approved by regulatory authorities in China, Hong Kong, Israel, Japan, South Korea, the United Arab Emirates and the US, the European Medicines Agency (EMA) issued a negative opinion on 26 July 2024. In its opinion, the Committee for Medicinal Products for Human Use (CHMP) of the EMA found that the benefits of treatment are not large enough to outweigh the risks associated with lecanemab.
Donanemab, the second amyloid-targeting antibody with proof of efficacy has been fully approved by the FDA in July 2024. The paper highlights the outcomes of clinical trials investigating lecanemab and donanemab, as well as the clinical meaningfulness of the observed effects. It also addresses the side effects of β-amyloid-targeting antibodies, barriers to access and the costs associated with treatment. The position statement calls for significant improvements in the treatment of AD. Regarding β-amyloid-targeting antibodies, their effects are considered as meaningful, with potential side effects deemed manageable.
However, it is assumed that only a fraction of all early AD patients will eventually receive treatment due to narrow eligibility criteria and barriers of access. In conclusion, the EADC investigators strongly endorse the use of these new compound in clinical practice for selected patients with treatment documentation in registries. They pointed out that this represents a critical step in advancing AD treatment and in shaping the health care systems for the new area of molecular-targeted treatment for neurodegenerative diseases. Read the EADC’s full position statement, here: https://doi.org/10.14283/jpad.2024.153
