Back to resultsAIT-082 Phase 1B Study
Primary Purpose
Memory Disorders
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AIT-082
Sponsored by
About this trial
This is an interventional treatment trial for Memory Disorders focused on measuring Memory, Mild cognitive impairment, Nerve growth factors
Eligibility Criteria
Sites / Locations
- University of California, San Diego
- Indiana University Alzheimer's Center
- University of Michigan
- Washington University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000180
First Posted
October 29, 1999
Last Updated
December 10, 2009
Sponsor
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00000180
Brief Title
AIT-082 Phase 1B Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Aging (NIA)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Disorders
Keywords
Memory, Mild cognitive impairment, Nerve growth factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AIT-082
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Grundman, M.D., M.P.H.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093-0949
Country
United States
Facility Name
Indiana University Alzheimer's Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0322
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12770610
Citation
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.
Results Reference
result
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AIT-082 Phase 1B Study
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