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AIT-082 Phase 1B Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000180
First Posted: November 1, 1999
Last Update Posted: December 11, 2009
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.
Information provided by:
National Institute on Aging (NIA)
  Purpose

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.


Condition Intervention Phase
Memory Disorders Drug: AIT-082 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000180


Locations
United States, California
University of California, San Diego
San Diego, California, United States, 92093-0949
United States, Indiana
Indiana University Alzheimer's Center
Indianapolis, Indiana, United States, 46202
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0322
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Institute on Aging (NIA)
Investigators
Principal Investigator: Michael Grundman, M.D., M.P.H. University of California, San Diego
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000180     History of Changes
Other Study ID Numbers: IA0008
3U01AG010483-08S2 ( U.S. NIH Grant/Contract )
First Submitted: October 29, 1999
First Posted: November 1, 1999
Last Update Posted: December 11, 2009
Last Verified: February 2005

Keywords provided by National Institute on Aging (NIA):
Memory
Mild cognitive impairment
Nerve growth factors

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms