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Landen JW, Cohen S, Billing CB, et al. Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy. Alzheimers Dement (N Y). 2017;3(3):339-347doi: 10.1016/j.trci.2017.04.003.
Landen, J. W., Cohen, S., Billing, C. B., Cronenberger, C., Styren, S., Burstein, A. H., Sattler, C., Lee, J. H., Jack, C. R., Kantarci, K., Schwartz, P. F., Duggan, W. T., Zhao, Q., Sprenger, K., Bednar, M. M., & Binneman, B. (2017). Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy. Alzheimer's & dementia (New York, N. Y.), 3(3), 339-347. https://doi.org/10.1016/j.trci.2017.04.003
Landen, Jaren W, et al. "Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy." Alzheimer's & dementia (New York, N. Y.) vol. 3,3 (2017): 339-347. doi: https://doi.org/10.1016/j.trci.2017.04.003
Landen JW, Cohen S, Billing CB, Cronenberger C, Styren S, Burstein AH, Sattler C, Lee JH, Jack CR, Kantarci K, Schwartz PF, Duggan WT, Zhao Q, Sprenger K, Bednar MM, Binneman B. Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy. Alzheimers Dement (N Y). 2017 May 10;3(3):339-347. doi: 10.1016/j.trci.2017.04.003. eCollection 2017 Sep. PMID: 29067341; PMCID: PMC5651443.
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Alzheimers Dement (N Y). 2017 May 10;3(3):339-347. doi: 10.1016/j.trci.2017.04.003. eCollection 2017 Sep.

Multiple-dose ponezumab for mild-to-moderate Alzheimer's disease: Safety and efficacy.

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

Jaren W Landen, Sharon Cohen, Clare B Billing, Carol Cronenberger, Scot Styren, Aaron H Burstein, Catherine Sattler, Jae-Hong Lee, Clifford R Jack, Kejal Kantarci, Pamela F Schwartz, William T Duggan, Qinying Zhao, Ken Sprenger, Martin M Bednar, Brendon Binneman

Affiliations

  1. Pfizer Inc., Groton, CT, USA.
  2. Toronto Memory Program, Toronto, Ontario, Canada.
  3. Department of Neurology, Asan Medical Center, Seoul, Korea.
  4. Department of Radiology, Mayo Clinic, Rochester, MN, USA.
  5. Pfizer Inc., Cambridge, MA, USA.

PMID: 29067341 PMCID: PMC5651443 DOI: 10.1016/j.trci.2017.04.003

Abstract

INTRODUCTION: Multiple intravenous doses of ponezumab, an anti-amyloid antibody, were evaluated in subjects with mild-to-moderate Alzheimer's disease (AD).

METHODS: In part A, 77 subjects were randomized to ponezumab 0.1, 0.5, or 1 mg/kg (75 treated) and 26 to placebo (24 treated). In part B, 63 subjects were randomized and treated with ponezumab 3 or 8.5 mg/kg and 32 with placebo. Subjects received 10 infusions over 18 months and were followed for 6 months thereafter.

RESULTS: Ponezumab was generally safe and well tolerated. Most common adverse events were fall (16.7% ponezumab, 21.4% placebo), headache (13.8%, 21.4%), and cerebral microhemorrhage (13.8%, 19.6%). Plasma ponezumab increased dose-dependently with limited accumulation. Cerebrospinal fluid penetration was low. Plasma Aβ

CONCLUSIONS: Multiple-dose ponezumab was generally safe, but not efficacious, in mild-to-moderate AD.

Keywords: Alzheimer's disease; Amyloid β; Biomarkers; Cerebrospinal fluid; Immunotherapy; Monoclonal antibody; Pharmacodynamics; Pharmacokinetics; Phase-II study; Ponezumab

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