Ponezumab in mild-to-moderate Alzheimer's disease : Randomized phase II PET-PIB study

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 Examination scores 16 to 26. Cohort Q was randomized to ponezumab 10 mg/kg (n = 12) or placebo (n = 6) quarterly. Cohort M was randomized to a loading dose of ponezumab 10 mg/kg or placebo, followed by monthly ponezumab 7.5 mg/kg (n = 12) or placebo (n = 6), respectively. Results Ponezumab was 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 ponezumab dosing schedules were generally safe and well tolerated but did not alter CSF biomarkers, brain amyloid burden, or clinical outcomes.

Andreasen, NielsKarolinska University Hospital (author)
Cronenberger, Carol L.Pfizer Inc. US (author)
Schwartz, Pamela F.Pfizer Inc. US (author)
Börjesson-Hanson, AnneSahlgrenska University Hospital (author)
Östlund, HenrikLund University,Lunds universitet,Klinisk minnesforskning,Forskargrupper vid Lunds universitet,Clinical Memory Research,Lund University Research Groups(Swepub:lu)med-hk_ (author)
Sattler, Catherine A.Pfizer Inc. US (author)
Binneman, BrendonPfizer Inc. US (author)
Bednar, Martin M.Pfizer Inc. US (author)
Pfizer Inc. USKarolinska University Hospital (creator_code:org_t)

In:Alzheimer's and Dementia: Translational Research and Clinical Interventions: Wiley3:3, s. 393-4012352-8737

By the author/editor: Landen, Jaren W.; Andreasen, Niels; Cronenberger, Ca ...; Schwartz, Pamela ...; Börjesson-Hanson ...; Östlund, Henrik; show more...; Sattler, Catheri ...; Binneman, Brendo ...; Bednar, Martin M ...; show less...

About the subject

MEDICAL AND HEALTH SCIENCES: MEDICAL AND HEAL ...; and Clinical Medicin ...; and Neurology

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