Mixed-effect circadian rhythm model for human erythrocyte acetylcholinesterase activity-application to the proof of concept of cholinesterase inhibition by acorn extract in healthy subjects with galantamine as positive control.

Purpose: The aim of this study was to develop a non-linear mixed effect circadian rhythm model of acetylcholinesterase (AChE) activity variation and to evaluate the inhibitory effect of acorn extract (2 g) and galantamine (16 mg), used as positive control, on human AChE in red blood cells (RBC). Met...

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Published in:European Journal of Clinical Pharmacology Vol. 68; no. 5; pp. 599 - 606
Main Authors: Han, Seunghoon, Lee, Jongtae, Jeon, Sangil, Hong, Taegon, Yim, Dong-Seok
Format: equations & formulas research tables/charts randomized controlled trial Journal Article
Published: Springer Nature May2012
Online Access:View this record in EBSCOhost
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      dt: May2012
      vid: 68
      iid: 5
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      pub: Springer Nature
      place: New York, New York
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        10.1007/s00228-011-1192-3
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        atl: Mixed-effect circadian rhythm model for human erythrocyte acetylcholinesterase activity-application to the proof of concept of cholinesterase inhibition by acorn extract in healthy subjects with galantamine as positive control.
      aug:
        au:
          Han, Seunghoon
          Lee, Jongtae
          Jeon, Sangil
          Hong, Taegon
          Yim, Dong-Seok
      sug:
        subj:
          Acetylcholinesterase Blood
          Cholinesterase Inhibitors
          Galanthamine Administration and Dosage
          Circadian Rhythm
          Alzheimer's Disease Drug Therapy
          Dementia Drug Therapy
          Plant Extracts Therapeutic Use
          Human
          Models, Statistical
          Randomized Controlled Trials
          Random Assignment
          Crossover Design
          Male
          Adult
          Middle Age
          South Korea
          Plant Extracts Administration and Dosage
          Time Factors
          Confidence Intervals
          Descriptive Statistics
          T-Tests
          Funding Source
          Adult: 19-44 years
          Middle Aged: 45-64 years
          Male
      ab: Purpose: The aim of this study was to develop a non-linear mixed effect circadian rhythm model of acetylcholinesterase (AChE) activity variation and to evaluate the inhibitory effect of acorn extract (2 g) and galantamine (16 mg), used as positive control, on human AChE in red blood cells (RBC). Methods: This was an open-label, randomized, three-way crossover study involving 12 healthy subjects who received one of the treatments in each study period: no treatment, acorn extract, and galantamine. RBC AChE activity was measured in peripheral blood samples collected at 0 (pre-dose), 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16 and 24 h post-dose administration. Non-linear mixed effect modeling was performed using NONMEM (ver. 7.0). Results: The circadian variation of AChE activity was best described using two mixed effect cosine functions, with periods of 24 and 12 h, respectively. When the inhibitory effect terms were added, the model was significantly improved for both acorn extract and galantamine. In terms of the effect, a 2-g single dose of acorn extract showed AChE inhibition (about 5%) similar to that of a 16-mg single dose of galantamine, in the first 24 h after administration. Conclusions: Based on the very pronounced inter- and intra-day variation in AChE activity in RBC, we conclude that the model-based approach is essential for the proof of concept and quantitation of AChE inhibition in human subjects.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        research
        tables/charts
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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