Alvaro Pascual-Leone, MD, PhD, Wolk Center for Memory Health, Hebrew SeniorLife & Harvard Medical School, Boston, MA; Linus Health, CMO, provides an overview of the development, safety, and efficacy of lecanemab, following its approval for the treatment of Alzheimer’s disease (AD) by the US Food and Drug Administration (FDA) on January 6th, 2023. Lecanemab, an anti-amyloid immunotherapy, is unique for its preferential binding of soluble amyloid-β protofibrils compared to aggregated amyloid plaques. In its recently completed Phase III trial, Clarity AD (NCT03887455), lecanemab slowed cognitive decline by 27% compared to placebo, as measured by CDR-SB. Similar slowing of decline was reported in other measures of cognitive function such as ADCOMS, ADAS-Cog14 and ADCS MCI-ADL. This marks lecanemab as the first of its kind to provide meaningful clinical benefit in this way, and led to its accelerated approval. This effect is, however, measurably small and should be balanced against the risks involved. One of the major risks is that lecanemab increases the occurrence of amyloid-related imaging abnormalities (ARIA) which can result in edema or hemorrhage. Three people, all of whom were receiving blood thinners at the time, died as a result of brain hemorrhages during the open-label extension. This has sparked questions into whether blood thinners should become a contraindication for lecanemab use. Dr Pascual-Leone now encourages the push for earlier AD diagnosis and identification of individuals most at risk of developing the disease, in order to administer lecanemab at this early disease stage. This interview took place at the Clinical Trials on Alzheimer’s Disease Congress 2022 in San Francisco.
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