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AIT-082 Phase 1B Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000180
Recruitment Status : Completed
First Posted : November 1, 1999
Last Update Posted : December 11, 2009
Information provided by:
National Institute on Aging (NIA)

Tracking Information
First Submitted Date  ICMJE October 29, 1999
First Posted Date  ICMJE November 1, 1999
Last Update Posted Date December 11, 2009
Study Start Date  ICMJE Not Provided
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE AIT-082 Phase 1B Study
Official Title  ICMJE Not Provided
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Memory Disorders
Intervention  ICMJE Drug: AIT-082
Study Arms  ICMJE Not Provided
Publications * 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. doi: 10.1016/s0024-3205(03)00320-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE Not Provided
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00000180
Other Study ID Numbers  ICMJE IA0008
3U01AG010483-08S2 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National Institute on Aging (NIA)
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Grundman, M.D., M.P.H. University of California, San Diego
PRS Account National Institute on Aging (NIA)
Verification Date February 2005

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