A positron emission tomography microdosing study with a potential antiamyloid drug in healthy volunteers and patients with Alzheimer's disease

Martin Bauer, Oliver Langer, Peter Dal-Bianco, Rudolf Karch, Martin Brunner, Aiman Abrahim, Rupert Lanzenberger, Andrea Hofmann, Christian Joukhadar, Paolo Carminati, Orlando Ghirardi, Paola Piovesan, Gianluigi Forloni, Mario E. Corrado, Nadège Lods, Robert Dudczak, Eduard Auff, Kurt Kletter, Markus Müller

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Abstract

This work describes a microdosing study with an investigational, carbon 11-labeled antiamyloid drug, 1,1′-methylene-di-(2-naphthol) (ST1859), and positron emission tomography (PET) in healthy volunteers (n = 3) and patients with Alzheimer's disease (n = 6). The study aimed to assess the distribution and local tissue pharmacokinetics of the study drug in its target organ, the human brain. Before PET studies were performed in humans, the toxicologic characteristics of ST1859 were investigated by an extended single-dose toxicity study according to guidelines of the Food and Drug Administration and European Medicines Agency, which are relevant for clinical trials with a single microdose. After intravenous bolus injection of 341 ± 21 MBq [11C]ST1859 (containing

Original languageEnglish
Pages (from-to)216-227
Number of pages12
JournalClinical Pharmacology and Therapeutics
Volume80
Issue number3
DOIs
Publication statusPublished - Sep 2006

ASJC Scopus subject areas

  • Pharmacology

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    Bauer, M., Langer, O., Dal-Bianco, P., Karch, R., Brunner, M., Abrahim, A., Lanzenberger, R., Hofmann, A., Joukhadar, C., Carminati, P., Ghirardi, O., Piovesan, P., Forloni, G., Corrado, M. E., Lods, N., Dudczak, R., Auff, E., Kletter, K., & Müller, M. (2006). A positron emission tomography microdosing study with a potential antiamyloid drug in healthy volunteers and patients with Alzheimer's disease. Clinical Pharmacology and Therapeutics, 80(3), 216-227. https://doi.org/10.1016/j.clpt.2006.05.007