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Safety and changes in plasma and cerebrospinal fluid amyloid beta after a single administration of an amyloid beta monoclonal antibody in subjects with Alzheimer disease


Siemers, Eric R., Friedrich, Stuart, Dean, Robert A., Gonzales, Celedon R., Farlow, Martin R., Paul, Steven M., Demattos, Ronald B.


Clinical Neuropharmacology, Volume: 33, No.: 2, Pages.: 67-73

Year of Publication



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.;

Bibtex Citation

@article{Siemers_2010, doi = {10.1097/wnf.0b013e3181cb577a}, url = {}, year = 2010, month = {mar}, publisher = {Ovid Technologies (Wolters Kluwer Health)}, volume = {33}, number = {2}, pages = {67--73}, author = {Eric R. Siemers and Stuart Friedrich and Robert A. Dean and Celedon R. Gonzales and Martin R. Farlow and Steven M. Paul and Ronald B. DeMattos}, title = {Safety and Changes in Plasma and Cerebrospinal Fluid Amyloid $upbeta$ After a Single Administration of an Amyloid $upbeta$ Monoclonal Antibody in Subjects With Alzheimer Disease}, journal = {Clinical Neuropharmacology} }


adverse, adverse effects, aged, alzheimer disease, analyses, and, antibodies monoclonal, antibodies monoclonal humanized, blood, cerebrospinal, cerebrospinal fluid, cognition, csf, drug effects, drug therapy, events, female, fluid, humans, immunology, male, middle aged, pharmacokinetics, placebos, plasma, solanezumab, therapeutic use

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Before and After Study

Type of Outcomes

Cognition, Other

Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions