Here is a link that those on this thread will get more out of than laymen.
These are the Abstracts Neotherapeutics is presenting at the Nov 7,2000 Society for Neuroscience Conference Meeting.
sfn.scholarone.com
Select search option and look for all references to AIT-082. You should get 7 of them.
Although the abstract below only deals with a phase 1b follow-up trial, they are in now phase 2/3 world wide trials with over 1,500 patients.
Abstract View
A MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE-DOSE, SAFETY AND PHARMACOKINETIC STUDY OF AIT-082 (NEOTROFIN) IN MILD ALZHEIMER'S DISEASE PATIENTS.
M. Grundman1*; H.T. Kim1; J.C. Morris2; M. Farlow3; J. Heidebrink4; A. Hake3; E. Rubin2; G. Ho1; Capparelli E1; A. Schultz1; K. Schafer1; W. Houston1; R. Thomas1; L.J. Thal1
1. University of California, San Diego, La Jolla, CA,
2. Washington University, School of Medicine,
3. Indiana University School of Medicine,
4. University of Michigan Health System,
We report here preliminary results from a Phase I, double-blind, placebo-controlled, multiple-dose safety, tolerance and pharmacokinetic study of the purine derivative, AIT-082, in mild Alzheimer's disease patients. AIT-082 is currently being developed as a potential treatment for Alzheimer's disease. Pre-clinical studies indicate that AIT-082 has memory enhancing properties, stimulates neuritogenesis and upregulates neurotrophic factors. Subjects were randomly assigned to one of three escalating dose cohorts of AIT-082 (100 mg/day, 500 mg/day, or 2,000 mg/day) or placebo. All patients received an oral dose of AIT-082 or placebo, daily, for one week. Pharmacokinetic assessments and cognitive measures (MMSE, ADAS-COG, and a neuropsychological battery) were obtained at the beginning and end of the trial. Thirty-six subjects participated. Twenty-four patients received active drug (eight in each dose cohort) and twelve patients received placebo. The mean age of the patients was 72 years with a mean education of 15 years. Twenty-two men and 14 women were enrolled in the study. At entry, the mean MMSE was 22 and the mean score on the ADAS-COG was 19. All subjects completed the study. There were no serious adverse events at any dose and the drug was well tolerated. Analyses of the cognitive and pharmacokinetic data are currently underway.Supported by: NIH grants #AG-10483, M01RR00042. |
