Nctid:
NCT00000180
Payload:
{"FullStudy"=>{"Rank"=>499133, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000008569", "ConditionMeshTerm"=>"Memory Disorders"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000019954", "ConditionAncestorTerm"=>"Neurobehavioral Manifestations"}, {"ConditionAncestorId"=>"D000009461", "ConditionAncestorTerm"=>"Neurologic Manifestations"}, {"ConditionAncestorId"=>"D000009422", "ConditionAncestorTerm"=>"Nervous System Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M29705", "ConditionBrowseLeafName"=>"Cognitive Dysfunction", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11552", "ConditionBrowseLeafName"=>"Memory Disorders", "ConditionBrowseLeafAsFound"=>"Memory Disorders", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M21826", "ConditionBrowseLeafName"=>"Neurobehavioral Manifestations", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M12404", "ConditionBrowseLeafName"=>"Neurologic Manifestations", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Nervous System Diseases", "ConditionBrowseBranchAbbrev"=>"BC10"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M11900", "InterventionBrowseLeafName"=>"Mitogens", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 1"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Treatment"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"February 2005", "CompletionDateStruct"=>{"CompletionDate"=>"June 2005", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 10, 2009", "StudyFirstSubmitDate"=>"October 29, 1999", "StudyFirstSubmitQCDate"=>"October 29, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 11, 2009", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"November 1, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"June 2005", "PrimaryCompletionDateType"=>"Actual"}}, "ConditionsModule"=>{"KeywordList"=>{"Keyword"=>["Memory", "Mild cognitive impairment", "Nerve growth factors"]}, "ConditionList"=>{"Condition"=>["Memory Disorders"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"12770610", "ReferenceType"=>"result", "ReferenceCitation"=>"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."}]}}, "DescriptionModule"=>{"BriefSummary"=>"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.\n\nThis 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."}, "EligibilityModule"=>{"Gender"=>"All", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"Accepts Healthy Volunteers"}, "IdentificationModule"=>{"NCTId"=>"NCT00000180", "BriefTitle"=>"AIT-082 Phase 1B Study", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute on Aging (NIA)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"IA0008"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"3U01AG010483-08S2", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/3U01AG010483-08S2", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"AIT-082", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"92093-0949", "LocationCity"=>"San Diego", "LocationState"=>"California", "LocationCountry"=>"United States", "LocationFacility"=>"University of California, San Diego"}, {"LocationZip"=>"46202", "LocationCity"=>"Indianapolis", "LocationState"=>"Indiana", "LocationCountry"=>"United States", "LocationFacility"=>"Indiana University Alzheimer's Center"}, {"LocationZip"=>"48109-0322", "LocationCity"=>"Ann Arbor", "LocationState"=>"Michigan", "LocationCountry"=>"United States", "LocationFacility"=>"University of Michigan"}, {"LocationZip"=>"63110", "LocationCity"=>"St. Louis", "LocationState"=>"Missouri", "LocationCountry"=>"United States", "LocationFacility"=>"Washington University"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Michael Grundman, M.D., M.P.H.", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"University of California, San Diego"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute on Aging (NIA)", "LeadSponsorClass"=>"NIH"}}}}}}
