Assessment of MAO-B occupancy in the brain with PET and [11C]-L-deprenyl-D2: a dose-finding study with a novel MAO-B inhibitor, EVT 301

Clin Pharmacol Ther. 2009 May;85(5):506-12. doi: 10.1038/clpt.2008.241. Epub 2009 Jan 7.

Abstract

Inhibition of monoamine oxidase type B (MAO-B) activity in the brain is a putative strategy for the treatment of Alzheimer's disease (AD). We performed a dose-selection and validation study of a novel, reversible MAO-B inhibitor, EVT 301. Sixteen healthy volunteers received selegiline (10 mg) or EVT 301 (25, 75, or 150 mg) daily for 7-8 days, and four subjects with AD received 75 mg of EVT 301. MAO-B occupancy in the brain was assessed using positron emission tomography (PET) with [11C]-L-deprenyl-D2. EVT 301 was found to dose-dependently occupy MAO-B in the human brain, with occupancy ranging from 58-78% at a dose of 25 mg to 73-90% at a dose of 150 mg. The corresponding occupancy after selegiline was 77-92%. Determination of MAO-B inhibition in blood platelets underestimated the actual brain occupancy achieved with EVT 301. A daily EVT 301 dose of 75 or 150 mg appears suitable for clinical efficacy studies in patients with AD.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Aged
  • Alzheimer Disease / drug therapy*
  • Alzheimer Disease / enzymology
  • Blood Platelets / drug effects
  • Blood Platelets / enzymology
  • Brain / drug effects
  • Brain / enzymology
  • Carbon Radioisotopes
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Malonates / administration & dosage
  • Malonates / pharmacology*
  • Middle Aged
  • Monoamine Oxidase / drug effects*
  • Monoamine Oxidase / metabolism
  • Monoamine Oxidase Inhibitors / administration & dosage
  • Monoamine Oxidase Inhibitors / pharmacology*
  • Positron-Emission Tomography / methods
  • Selegiline / pharmacology

Substances

  • Carbon Radioisotopes
  • Malonates
  • Monoamine Oxidase Inhibitors
  • N-(4-(3-fluorobenzyloxy)phenyl)malonamide
  • Selegiline
  • Monoamine Oxidase