Indianapolis, Indiana 46202

  • Memory Disorders

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.


Criteria:


Study is Available At:


Original ID:

IA0008


NCT ID:

NCT00000180


Secondary ID:

3U01AG10483-08S2


Study Acronym:


Brief Title:

AIT-082 Phase 1B Study


Official Title:


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Aging (NIA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Masking: Double-Blind, P


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:Michael Grundman, M.D., M.P.H.
Principal Investigator
University of California, San Diego

Study Dates

Completion Date:June 2005
Completion Type:Actual
Primary Completion Date:June 2005
Primary Completion Type:Actual
Verification Date:February 2005
Last Changed Date:December 10, 2009
First Received Date:October 29, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:AIT-082

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Aging (NIA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
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.
PMID:12770610

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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