AIT-082 Phase 1B Study

• ClinicalTrials.gov Identifier: NCT00000180
• Recruitment Status: Completed
• First Posted: November 1, 1999
• Last Update Posted: December 11, 2009
• Sponsor: National Institute on Aging (NIA)
• Information provided by: National Institute on Aging (NIA)

Tracking Information

• First Submitted Date: October 29, 1999
• First Posted Date: November 1, 1999
• Last Update Posted Date: December 11, 2009
• Study Start Date: Not Provided
• Actual Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AIT-082 Phase 1B Study
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Masking: Double; Primary Purpose: Treatment
• Condition: Memory Disorders
• Intervention: Drug: AIT-082
• Study Arms: 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment: Not Provided
• Original Enrollment: Not Provided
• Actual Study Completion Date: June 2005
• Actual Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
• Eligibility Criteria: Not Provided

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00000180
• Other Study ID Numbers: IA0008; 3U01AG010483-08S2 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Not Provided
• Original Responsible Party: Same as current
• Current Study Sponsor: National Institute on Aging (NIA)
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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