Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study
2017
Abstract Introduction The safety, pharmacokinetics, and effect on peripheral and central amyloid β (Aβ) of multiple doses of
ponezumab, an anti-Aβ monoclonal antibody, were characterized in subjects with mild-to-moderate Alzheimer's disease treated for 1 year. Methods Subjects were aged ≥50 years with
Mini–Mental State Examinationscores 16 to 26. Cohort Q was randomized to
ponezumab10 mg/kg ( n = 12) or placebo ( n = 6) quarterly. Cohort M was randomized to a
loading doseof
ponezumab10 mg/kg or placebo, followed by monthly
ponezumab7.5 mg/kg ( n = 12) or placebo ( n = 6), respectively. Results
Ponezumabwas generally well tolerated. Plasma concentrations increased dose dependently, but cerebrospinal fluid (CSF) penetration was low. Plasma Aβ increased dose dependently with
ponezumab, but CSF biomarkers, brain amyloid burden, cognition, and function were not affected. Conclusions Both
ponezumabdosing schedules were generally safe and well tolerated but did not alter CSF biomarkers, brain amyloid burden, or clinical outcomes.
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