AIT-082 Phase 1B Study

NCT ID: NCT00000180

Last Updated: 2009-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Completion Date

2005-06-30

Brief Summary

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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

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Conditions

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Memory Disorders

Keywords

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Memory Mild cognitive impairment Nerve growth factors

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AIT-082

Intervention Type DRUG

Eligibility Criteria

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Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role lead

Principal Investigators

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Michael Grundman, M.D., M.P.H.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Indiana University Alzheimer's Center

Indianapolis, Indiana, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 12770610 (View on PubMed)

Other Identifiers

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3U01AG010483-08S2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IA0008

Identifier Type: -

Identifier Source: org_study_id