Solanezumab does not slow cognitive decline in preclinical Alzheimer disease

For patients with preclinical Alzheimer disease, solanezumab does not slow cognitive decline, according to a study published online July 17 in the New England Journal of Medicine to coincide with the annual Alzheimer's Association International Conference, held from July 16 to 20 in Amsterdam.

Reisa A. Sperling, M.D., from Massachusetts General Hospital in Boston, and colleagues tested solanezumab, which targets monomeric amyloid, in a phase 3 trial involving persons aged 65 to 85 years with preclinical Alzheimer disease and elevated brain amyloid levels. Participants were randomly assigned to receive solanezumab or placebo (578 and 591, respectively).

The researchers found that the mean change in the Preclinical Alzheimer Cognitive Composite score was −1.43 and −1.13 in the solanezumab and placebo groups, respectively, at 240 weeks. Amyloid levels on brain positron emission tomography increased by a mean of 11.6 and 19.3 centiloids in the solanezumab and placebo groups, respectively. Less than 1 percent of the participants in each group had amyloid-related imaging abnormalities (ARIA) with edema. ARIA with microhemorrhage or hemosiderosis occurred in 29.2 and 32.8 percent of participants in the solanezumab and placebo groups, respectively.

"The anti-monomeric amyloid antibody solanezumab did not slow the progression of preclinical Alzheimer's disease as compared with placebo on the basis of the primary or secondary cognitive and functional end points over a period of 4.5 years," the authors write.

The study was partially funded by Eli Lilly, which also supplied the active medication and placebo, and in-kind support from Avid Radiopharmaceuticals and Cogstate.

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