- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000180
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.
Study Overview
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92093-0949
- University of California, San Diego
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Alzheimer's Center
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Michigan
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Ann Arbor, Michigan, United States, 48109-0322
- University of Michigan
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Missouri
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St. Louis, Missouri, United States, 63110
- Washington University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Investigators
- Principal Investigator: Michael Grundman, M.D., M.P.H., University of California, San Diego
Publications and helpful links
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IA0008
- 3U01AG010483-08S2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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