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AIT-082 Phase 1B Study

This study has been completed.
Study NCT00000180.   Last updated on June 23, 2005.   Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  AIT-082 Phase 1B Study
Official Title 
Brief Summary

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.

Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Randomized, Double-Blind, Placebo Control
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Memory Disorders
Intervention  Drug: AIT-082
MEDLINE PMIDs 12770610
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date 
Completion Date
Eligibility Criteria 
Gender Both
Ages
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00000180
Organization ID IA0008
Secondary IDs †† 3U01AG10483-08S2
Study Sponsor  National Institute on Aging (NIA)
Collaborators ††
Investigators 
Principal Investigator:     Michael Grundman, M.D., M.P.H.     University of California, San Diego    
Information Provided By National Institute on Aging (NIA)
Verification Date February 2005
First Received Date  October 29, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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