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Solanezumab in Preclinical Alzheimer’s Disease

An agent that targets monomeric amyloid in persons with elevated brain amyloid levels, solanezumab was not more effective than placebo in slowing cognitive decline in a 240-week phase 3 trial in persons with preclinical Alzheimer’s disease

The A4 study included 1,169 persons aged 65 to 85 years with a global Clinical Dementia Rating score of 0 (range, 0 to 3, with 0 indicating no cognitive impairment and 3 severe dementia), a score on the Mini–Mental State Examination of 25 or more (range, 0 to 30, with lower scores indicating poorer cognition), and elevated brain amyloid levels on 18F-florbetapir positron-emission tomography (PET). Participants were randomized to solanezumab 1600 mg intravenously every 4 weeks or placebo.

Over 240 weeks, the interventions had these effects on a primary endpoint of the change in the Preclinical Alzheimer Cognitive Composite (PACC) score: “The mean age of the participants was 72 years, approximately 60% were women, and 75% had a family history of dementia. At 240 weeks, the mean change in PACC score was −1.43 in the solanezumab group and −1.13 in the placebo group (difference, −0.30; 95% confidence interval, −0.82 to 0.22; P=0.26). Amyloid levels on brain PET increased by a mean of 11.6 centiloids in the solanezumab group and 19.3 centiloids in the placebo group. Amyloid-related imaging abnormalities (ARIA) with edema occurred in less than 1% of the participants in each group. ARIA with microhemorrhage or hemosiderosis occurred in 29.2% of the participants in the solanezumab group and 32.8% of those in the placebo group.”

Source: New England Journal of Medicine