AIT-082 is a potentially new therapeutic agent for Alzheimer's Disease. Preclinical experiments indicate that AIT-082 has memory enhancing and neurotrophic properties. This protocol describes a Phase I development program for AIT-082 in Alzheimer's disease. Two clinical trials are planned. The first clinical trial will evaluate single dose safety, tolerance and pharmacokinetics in elderly, non-demented, healthy volunteers. Eight subjects will be recruited. Each subject will receive a single oral dose of AIT-082 on a weekly basis for five weeks. Subjects will be observed for adverse reactions throughout the study. Subjects will be permitted to advance to the next higher dose only when the last preceding dose is deemed safe and well tolerated. Blood and urine will be collected to determine pharmacokinetic parameters. A second trial will evaluate safety and tolerance of multiple dosing in patients with Alzheimer's disease. Twenty four patients will receive medication three times daily for one week. Patients will be randomized to receive one of three doses of AIT-082 or placebo. The frequency of physical exam abnormalities and adverse events will be tabulated for each dose. Selected efficacy measures will be incorporated for possible evidence of therapeutic benefit. These include the Cognitive portion of the Alzheimer's Disease Assessment Scale, the ADCS-Clinical Global Impression of Change, the Mini-Mental State Examination and the ADCS- Activities of Daily Living scale.
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