AIT-082 is currently being developed as a new therapeutic agent for Alzheimer's Disease (AD). Preclinical experiments indicate that AIT-082 has memory enhancing and neurotrophic properties. Two prior single-dose, Phase 1 studies with AIT-082 have shown good safety and tolerability in humans. This protocol describes a Phase 1 clinical trial of AIT-082 in mild AD patients. Multiple-dose safety, tolerance and pharmacokinetics will be evaluated. The study will be conducted at four clinical sites with access to a General Clinical Research Center. Thirty-six patients will be recruited (nine from each clinical site). Each patient will receive an oral dose of AIT-082 or placebo, daily, for one week. Data collected on patients receiving three different doses of AIT-082 will be compared to placebo. We plan to recruit three escalating dose cohorts with twelve patients in each cohort. Each cohort will consist of eight patients randomized to a dose of AIT-082, four patients to placebo. Patients will be observed for adverse reactions throughout the study. Blood will be collected to determine the phamacokinetic parameters of AIT-082 with multiple dosing. Preliminary efficacy data utilizing neuropsychological tests will be obtained which may suggest possible short term effects of AIT-082 on cognition and memory in AD.
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