This clinical trial will evaluate single dose safety, tolerance and pharmacokinetics in elderly, non-demented, healthy volunteers. The study will be conducted at two clinical sites having access to a General Clinical Research Center. Eight subjects will be recruited (four from each clinical site). Each subject will receive a single oral dose of AIT-082 or placebo on a weekly basis for five weeks. Subjects will be permitted to advance to a higher dose only if the preceding dose is deemed safe and well tolerated. Subjects will be observed for adverse reactions throughout the study. Blood and urine will be collected to determine the pharmacokinetic parameters of AIT-082. Preliminary efficacy data utilizing neuropsychological performance tests will be obtained which may suggest beneficial effects of AIT-082 on memory in humans. The study will be a randomized, double-blind, parallel group, dose escalation trial. The eight patients will be randomized across two clinical sites. Six subjects will receive escalating doses of the active agent (AIT-082). Two subjects will receive placebo throughout the study. Standard statistical methods will be used to explore differences in vital signs and laboratory safety results at each dose. The frequency of physical exam abnormalities and adverse events in patients receiving AIT-082 will be tabulated and compared at each incremental dose as well as to subjects receiving placebo medication only. The pharmacokinetic parameters (e.g. AUC, Cl/F, Kel, Cmax, tmax, t 1/2, U0-24 hr) for AIT-082 will be derived using standard software (e.g. SAS, PCNONLIN or MKMODEL) at the different dose levels. Neuropsychological performance will be summarized and examined statistically to determine if there is preliminary evidence of a dose related treatment effect (Friedman's test).
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