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ABSTRACT
Introduction
There is no cure for Alzheimer’s disease, which is the sixth leading cause of death in the USA. Lecanemab is anti-Aβ monoclonal antibody approved for the treatment of early Alzheimer’s disease but is only marginally effective. Other antibodies are being developed including solanezumab.
Areas covered
A phase 3 clinical trial of solanezumab in preclinical Alzheimer’s disease. In the A4 study, solanezumab did not reduce the decline in cognition or function and had no effect on brain amyloid burden.
Expert opinion
After the poor results in the EXPEDITION series of trials, the development of solanezumab should have been terminated. The rationale for undertaking the A4 trial was questionable, and the lack of benefit was probable. The controversial approval of two anti-Aβ monoclonal antibodies (aducanumab and lecanemab) for the treatment of Alzheimer’s disease by the US Food and Drug Administration (FDA), despite a high incidence of amyloid-related imagining abnormalities (ARIA), may be fueling this continuation of clinical development of agents such as solanezumab. The lesson from the A4 trial is that more careful/realistic consideration needs to be given before embarking on further phase 3 trials with anti-Aβ monoclonal antibodies.
Declaration of interest
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants, or patents received or pending, or royalties.
Reviewer disclosure
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.