OBJECTIVES: Active and passive immunization strategies have been suggested as 
possible options for the treatment of Alzheimer disease (AD). LY2062430 
(solanezumab) is a humanized monoclonal antibody being studied as a putative 
disease-modifying treatment of AD.
METHODS: Patients with mild to moderate AD were screened and selected for 
inclusion. Initial screening was performed for 54 subjects, and 29 of these 
underwent additional screening; after this second screening, a total of 19 
subjects were included. Single doses of solanezumab using 0.5, 1.5, 4.0, and 
10.0 mg/kg were administered. Safety assessments included gadolinium-enhanced 
magnetic resonance imaging of the brain and cerebrospinal fluid (CSF) analyses 
at baseline and 21 days after dosing. Plasma and CSF concentrations of 
solanezumab and amyloid beta (Abeta) and cognitive evaluations were obtained.
RESULTS: Administration of solanezumab was generally well tolerated except that 
mild self-limited symptoms consistent with infusion reactions occurred for 2 of 
4 subjects given 10 mg/kg. No evidence of meningoencephalitis, microhemorrhage, 
or vasogenic edema was present based on magnetic resonance image and CSF 
analyses. A substantial dose-dependent increase in total (bound plus unbound) 
Abeta was demonstrated in plasma; CSF total Abeta also increased. No changes in 
cognitive scores occurred.
CONCLUSIONS: A single dose of solanezumab was generally well tolerated, although 
infusion reactions similar to those seen with administration of other proteins 
may occur with higher doses. A dose-dependent change in plasma and CSF Abeta was 
observed, although changes in cognitive scores were not noted. Further studies 
of solanezumab for the treatment of AD are warranted.