Real‐world one‐year estimation of the candidates for lecanemab in a South Korean memory clinic

Abstract

AbstractBackgroundResults from an 18‐month Phase 3 clinical trial showed that lecanemab reduced markers of amyloid on early Alzheimer’s disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events. As the lecanemab recently received accelerated approval by the US Food and Drug Administation, consideration for prescribing it in the right person, at the right dose and in a very carefully monitored way in a real‐world practice is necessary now.MethodIn this study, we aimed to estimate the candidates for lecanemab in a South Korean memory clinic based on one‐year clinical data. We reviewed retrospectively the medical records of a total 344 patients (211 females, 69.7±9.3 years old) who visited the memory clinic and took the amyloid PET at the department of Neurology, Ajou University Hospital in 2022. We tried to find the patients whose clinical characteristics fit with the inclusion as well as exclusion criteria from the Phase 4 clinical trial of lecanemab.ResultThe patients consisted of 14 subjective cognitive complaints, 139 mild cognitive impairments (MCI), 107 Alzheimer’s disease (AD) dementia, or 84 other neurodegenerative diseases whose amyloid positivity was 28.6%, 43.2%, 72.0%, or 10.7%, respectively. Among patients with evidence of amyloid deposition, 4 MCI and 38 AD dementia were within the exclusion criteria because they scored less than 22 at the Mini‐Mental State Examination (MMSE). Other 7 patients with AD dementia would be also excluded because they scored both Global Clinical Dementia Rating (CDR) score greater than 1 and <22 at the MMSE. One more AD dementia patient had no data of cognitive test. Finally, 56 patients with MCI and 31 patients with AD dementia met the criteria for using the lecanemab.ConclusionOur study showed that amyloid PET was already integrated in the real‐world Korean practice. In addition, the amyloid‐positivity data from real‐world practice in a South Korean memory clinic matched well with previous research data. It is expected that this pattern of the Korean practice might contribute to give real‐world data for prescribing the lecaemab in the future.