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.
An epizootic of chronic respiratory disease was found in a rat colony. Lungs of the symptomatic rats showed histopathologically severe peribronchial lymphoid cuffing. Filamentous bacteria were detected on the border of the tracheal and bronchial epithelium by light and electron microscopy. These bacteria did not grown on artificial media but propagated in embryonated chicken eggs. The disease was thus diagnosed as cilia-associated respiratory (CAR) bacillus infection. Epizootiological observations of the natural and experimentally induced cases revealed that the disease was highly contagious, slowly progressive and intractable. Contact infection may play a major role in the transmission of this disease.
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