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P1‐448: Solanezumab was safe and well‐tolerated for Asian patients with mild‐to‐moderate Alzheimer's disease in a multicenter, randomized, open‐label, multi‐dose study
Author(s) -
Goto Taro,
Fujikoshi Shinji,
Uenaka Kazunori,
Nishiuma Shinichi,
Siemers Eric R.,
Dean Robert A.,
Takahashi Michihiro
Publication year - 2010
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2010.05.1003
Subject(s) - tolerability , medicine , adverse effect , pharmacokinetics , pharmacodynamics , open label study , randomized controlled trial , open label , pharmacology , gastroenterology
Background: Solanezumab is a humanized anti-amyloid-b monoclonal antibody being developed as a passive-immunization treatment to slow the progression of AD. It recognizes a mid-domain epitope of the amyloid-b (Ab) peptide and elicits continuous changes of Ab dynamics. Although multiple doses of solanezumab are safe and well tolerated in non-Japanese, there are no data available in Asians. This is the first study to describe the safety and tolerability of multiple doses of solanezumab in Asian patients with mild-to-moderate AD. Methods: This study was a multicenter, randomized, open-label, parallel study in Japan. Duration was 5 days to 5 weeks in Period I (eligibility), 8 weeks in Period II (treatment), and 16 weeks in Period III (follow-up). Patients were randomized 1:1:1 to 3 solanezumab dose arms: iv infusions of 400 mg once every week (QW group), 400 mg once every four weeks (Q4W group) and 400 mg once every eight weeks (Q8W group). All patients visited every week and blood samples were taken for safety, pharmacokinetics, and pharmacodynamics. Results: Thirty five patients entered the study. Thirty three patients were randomly assigned to treatment, received at least one dose of study drug, and completed the study. Eighteen patients (54.5%) were female, fifteen patients (45.5%) were male, and their ages ranged from 56 to 84 years (mean 1⁄4 70.7). There were no serious adverse events related to solanezumab; although treatment-emergent adverse events (TEAEs) were reported in 8 patients from the Q8W group (66.7%), 5 patients from the Q4W group (50.0%), and 5 patients from the QW group (45.5%). Adverse events reported were mild or moderate except one event. Only one event (pain in extremity) was judged as severe but was not related to the study drug or a study procedure. There were no infusion reactions, MRI evidence of meningoencephalitis, or clinically meaningful laboratory abnormalities. Conclusions: Solanezumab was safe and well-tolerated up to 400 mg once a week in Asian (Japanese) AD patients.