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Comparison of pharmacokinetics, pharmacodynamics, safety, and tolerability of the amyloid β monoclonal antibody solanezumab in Japanese and white patients with mild to moderate alzheimer disease


Uenaka, Kazunori, Nakano, Masako, Willis, Brian A., Friedrich, Stuart, Ferguson-Sells, Lisa, Dean, Robert A., Ieiri, Ichiro, Siemers, Eric R.


Clinical Neuropharmacology, Volume: 35, No.: 1, Pages.: 25-29

Year of Publication



Objectives: Solanezumab is a humanized anti-amyloid β monoclonal antibody being developed as a passive immunization treatment to slow the progression of Alzheimer disease (AD). Pharmacokinetics (PK), pharmacodynamics, safety, and tolerability after a single dose of solanezumab were compared between Japanese and white patients with AD.; Methods: Japanese and white patients with mild to moderate AD were enrolled in 2 separate studies. In each study, single doses of solanezumab at 0.5, 1.5, 4.0, and 10.0 mg/kg were administered by intravenous infusion. Plasma concentrations of solanezumab and amyloid β (Aβ) were measured. A safety assessment was conducted up to 112 days after a single-dose administration of solanezumab.; Results: The PK profile was similar between the Japanese and the white patients with AD. In both the Japanese and the white patients, clearance and volume of distribution appeared similar across doses, suggesting that solanezumab exhibited dose-proportional PK within the studied dose range. A marked increase in plasma total Aβ was observed; both the magnitude and time to reach maximum concentration tended to increase with increasing doses of solanezumab. Administration of solanezumab was generally well-tolerated in both Japanese and white patients with AD.; Conclusions: When administered as a per-kilogram single dose of solanezumab, PK and pharmacodynamics (plasma total Aβ1-40 concentration) in the Japanese patients with AD were comparable with those in the white patients with AD. In addition, solanezumab was generally well tolerated in both Japanese and white patients at all dose levels.;

Bibtex Citation

@article{Uenaka_2012, doi = {10.1097/wnf.0b013e31823a13d3}, url = {}, year = 2012, publisher = {Ovid Technologies (Wolters Kluwer Health)}, volume = {35}, number = {1}, pages = {25--29}, author = {Kazunori Uenaka and Masako Nakano and Brian A. Willis and Stuart Friedrich and Lisa Ferguson-Sells and Robert A. Dean and Ichiro Ieiri and Eric R. Siemers}, title = {Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of the Amyloid $upbeta$ Monoclonal Antibody Solanezumab in Japanese and White Patients With Mild to Moderate Alzheimer Disease}, journal = {Clinical Neuropharmacology} }


adverse, aged, aged, 80 and over, alzheimer disease, amyloid betapeptides, antibodies monoclonal humanized, antipsychotic agents, area under curve, asian continental ancestry group, blood, cohort studies, doseresponse relationship drug, drug therapy, enzymelinked immunosorbent assay, european continental ancestry group, events, female, humans, immunology, infusions intravenous, japan, male, middle aged, solanezumab, therapeutic use, time factors

Countries of Study

Japan, USA

Types of Dementia

Alzheimer’s Disease

Types of Study

Before and After Study

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions