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AIT-082 Phase 1B Study
This study has been completed.
Study NCT00000180   Information provided by National Institute on Aging (NIA)
First Received: October 29, 1999   Last Updated: June 23, 2005   History of Changes

October 29, 1999
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00000180 on ClinicalTrials.gov Archive Site
 
 
 
AIT-082 Phase 1B Study
 

AIT-082 is a novel small molecule that crosses the blood-brain barrier to enhance nerve function by increasing levels of neurotrophic growth factors and encouraging nerve sprouting in the brain. Preclinical studies in animals have shown that AIT-082 improves memory in aged animals and in animals with neurological deficits.

This study was a double-blind placebo-controlled safety study that was designed to study whether AIT-082 may delay age-related mental decline. Eight healthy older volunteers at two clinical sites were given single, weekly, rising doses of AIT-082 or placebo for 5 weeks; were tested for side effects and absorption; and underwent a battery of neuropsychological memory tests, including word and number recall tests.

 
Phase I
Interventional
Treatment, Randomized, Double-Blind, Placebo Control
Memory Disorders
Drug: AIT-082
 
Grundman M, Capparelli E, Kim HT, Morris JC, Farlow M, Rubin EH, Heidebrink J, Hake A, Ho G, Schultz AN, Schafer K, Houston W, Thomas R, Thal LJ; Alzheimer's Disease Cooperative Study. A multicenter, randomized, placebo controlled, multiple-dose, safety and pharmacokinetic study of AIT-082 (Neotrofin) in mild Alzheimer's disease patients. Life Sci. 2003 Jun 20;73(5):539-53.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 
 
Both
 
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000180
 
IA0008, 3U01AG10483-08S2
National Institute on Aging (NIA)
 
Principal Investigator: Michael Grundman, M.D., M.P.H. University of California, San Diego
National Institute on Aging (NIA)
February 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP