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Landen JW, Andreasen N, Cronenberger CL, et al. Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study. Alzheimers Dement (N Y). 2017;3(3):393-401doi: 10.1016/j.trci.2017.05.003.
Landen, J. W., Andreasen, N., Cronenberger, C. L., Schwartz, P. F., Börjesson-Hanson, A., Östlund, H., Sattler, C. A., Binneman, B., & Bednar, M. M. (2017). Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study. Alzheimer's & dementia (New York, N. Y.), 3(3), 393-401. https://doi.org/10.1016/j.trci.2017.05.003
Landen, Jaren W, et al. "Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study." Alzheimer's & dementia (New York, N. Y.) vol. 3,3 (2017): 393-401. doi: https://doi.org/10.1016/j.trci.2017.05.003
Landen JW, Andreasen N, Cronenberger CL, Schwartz PF, Börjesson-Hanson A, Östlund H, Sattler CA, Binneman B, Bednar MM. Ponezumab in mild-to-moderate Alzheimer's disease: Randomized phase II PET-PIB study. Alzheimers Dement (N Y). 2017 Jun 08;3(3):393-401. doi: 10.1016/j.trci.2017.05.003. eCollection 2017 Sep. PMID: 29067345; PMCID: PMC5651442.
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Alzheimers Dement (N Y). 2017 Jun 08;3(3):393-401. doi: 10.1016/j.trci.2017.05.003. eCollection 2017 Sep.

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

Alzheimer's & dementia (New York, N. Y.)

Jaren W Landen, Niels Andreasen, Carol L Cronenberger, Pamela F Schwartz, Anne Börjesson-Hanson, Henrik Östlund, Catherine A Sattler, Brendon Binneman, Martin M Bednar

Affiliations

  1. Pfizer Inc., Groton, CT, USA.
  2. Karolinska University Hospital, Stockholm, Sweden.
  3. Sahlgrenska University Hospital, Gothenburg, Sweden.
  4. Skanes University Hospital, Malmö, Sweden.
  5. Pfizer Inc., Cambridge, MA, USA.

PMID: 29067345 PMCID: PMC5651442 DOI: 10.1016/j.trci.2017.05.003

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 Examination scores 16 to 26. Cohort Q was randomized to ponezumab 10 mg/kg (

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.

Keywords: Alzheimer's disease; Amyloid; Anti-drug antibodies; Antibody; PIB; Pharmacodynamics; Pharmacokinetics; Ponezumab; Safety; Tolerability

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