The applicant proposes to develop AIT-082 for the treatment of dementia due to Alzheimer's disease, stroke or aging. In Phase I, he plans to complete the preclinical studies needed to submit an Investigational New Drug (IND) exemption application to the Food and Drug Administration (FDA). Specifically, he will: (1) determine the preclinical pharmacodynamics/ pharmacokinetics of AIT-082, (2) conduct preclinical toxicological testing, (3) conduct additional preclinical studies on the mechanism of action of AIT-082, and (4) file an IND application.
The aim of Phase II will be to establish the clinical safety and efficacy of AIT-082.
