Promising trial results for the anti-amyloid monoclonal lecanamab in early Alzheimer’s disease have been given a cautious welcome by dementia researchers.
The drug was shown to reduce cognitive decline by 27% in patients with early stage Alzheimer’s disease and also reduce amyloid levels in the brain according to phase 3 trial results from the released by Eisai and Biogen.
The Clarity AD randomised controlled trial which involved 1,795 people with early AD, showed that lecanemab treatment (10 mg/kg bi-weekly) met the primary endpoint and reduced clinical decline on the global cognitive and functional scale, CDR-SB (Clinical Dementia Rating-Sum of Boxes), compared with placebo at 18 months, with a treatment difference in the score change of -0.45 (p=0.00005) in the analysis of intent-to-treat (ITT) population.
Lecanemab treatment showed highly statistically significant changes in CDR-SB from baseline compared to placebo starting as early as six months.
Key secondary endpoints including amyloid level changes also showed highly statistically significant results compared with placebo. These were change from baseline at 18 months in amyloid levels in the brain measured by amyloid positron emission tomography (PET), the AD Assessment Scale-cognitive subscale14 (ADAS-cog14), AD Composite Score (ADCOMS) and the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL).
The incidence of amyloid-related imaging abnormalities-edema/effusion (ARIA-E), and ARIA-H (ARIA cerebral microhaemorrhages, cerebral macrohaemorrhages, and superficial siderosis) was 21.3% in the lecanemab group and 9.3% in the placebo group, which was within expectations, according to the company.
Dr Catherine Mummery, Consultant Neurologist, National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust, UK, said the lecanemab CLARITY results were “exciting” and the clearest indicator to date that targeting amyloid levels in the brain could slow cognitive decline.