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.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
2M01RR000750-28
Application #
6411407
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
1976-12-01
Project End
2004-11-30
Budget Start
Budget End
Support Year
28
Fiscal Year
2000
Total Cost
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Type
DUNS #
005436803
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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