AIT-082 Phase 1B Study

Phase 1

Completed

• Conditions: Memory Disorders

• Registration Number: NCT00000180
• Lead Sponsor: National Institute on Aging (NIA)

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 available

Study Timeline

• Study First Submitted: 1999-10-29
• Study First Submitted QC: 1999-10-29
• Study First Posted: 1999-11-01
• Status Verified: 2005-02
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Last Update Submitted: 2009-12-10
• Last Update Posted: 2009-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

University of California, San Diego; 🇺🇸 San Diego, California, United States

Indiana University Alzheimer's Center; 🇺🇸 Indianapolis, Indiana, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Washington University; 🇺🇸 St. Louis, Missouri, United States