Abstract

AIT-082 is being developed as a new therapeutic agent for Alzheimer' 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 Phase 1B clinical trial is designed to assess multiple-dose safety, tolerability and pharmacokinetics of AIT-082 in patients diagnosed with mild Alzheimer's disease. The study will be conducted at four sites with General Clinical Research Centers. Thirty-six patients will be recruited (nine at each clinical site). Each patient will receive an oral dose of AIT-082 or placebo, daily for one week. Patients will be divided into three escalating dose cohorts, 12 patients each. Each cohort will consist of eight patients randomized to a dose of AIT-082 (100mg/day, 500mg/day or 2000 mg/day) plus four patients to placebo. Patients will be observed for adverse reactions throughout the study. Blood will be collected to determine the pharmacokinetic parameters of AIT-082 with multiple dosing. Preliminary efficacy data will be collected. Neuropsychological tests will be used to assess possible short-term effects of AIT-082 on cognition and memory in AD.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000042-39
Application #
6297060
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
39
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
University of Michigan Ann Arbor
Department
Type
DUNS #
791277940
City
Ann Arbor
State
MI
Country
United States
Zip Code
48109

  Publications

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