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| Research article summary (published 9 Jul 2002): |
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Safety, pharmacokinetics, and effects on cognitive function of multiple doses of GTS-21 in healthy, male volunteers.
Full Abstract
This study was designed to determine the safety, tolerability, pharmacokinetics and effects on cognitive function of GTS-21 in healthy, male volunteers. A total of 18 subjects were randomized to GTS-21 (25, 75 and 150 mg) or placebo administered three times daily (first 4 days, once on Day 5) for three, 5-day sessions. GTS-21 was well tolerated up to doses of 450 mg/day, with no clinically significant safety findings. C(max) and the area under the plasma concentration of GTS-21 and the metabolite 4-OH-GTS-21 increased in a dose-related fashion; although considerable intersubject variability occurred, it decreased with continued dosing. GTS-21 showed statistically significant enhancement of three measures of cognitive function (attention, working memory, episodic secondary memory) compared to placebo. A relationship between exposure to GTS-21 and the magnitude of the cognitive response was apparent, with maximal effect approached for doses between 75 and 150 mg three times a day. These data indicate that GTS-21 may represent a novel treatment for dementia.
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Author information
Author/s: Kitagawa, Harumi (H); Takenouchi, Toshiharu (T); Azuma, Ryotaro (R); Wesnes, Keith A (KA); Kramer, William G (WG); Clody, Donald E (DE); Burnett, Angela L (AL);
Affiliation: Quintiles, Inc., Tokyo, Japan.
Journal and publication information
Publication Type: Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Journal: Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology (Neuropsychopharmacology), published in United States. (Language: eng)
Reference: 2003-Mar; vol 28 (issue 3) : pp 542-51
Dates: Created 2003/03/11; Completed 2003/05/07; Revised 2006/11/15;
PMID: 12629535, status: MEDLINE (last retrieval date: 11/6/2008)
Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.
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